RhinitisPhase 4NCT06448585
Dietary Supplement (Beta-Glucans) in Allergic Patients Undergoing Subcutaneous Immunotherapy.
A Phase 4 study testing Specific immunotherapy (SIT) treatment, Dietary Supplement: ABB C1 and Mini-tablets with pork extract in people with Rhinitis and Allergic Rhinoconjunctivitis, run by Gala Servicios Clinicos S.L. at 1 site in Spain.
Trial summary
The present study will attempt to determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis, Allergic Rhinoconjunctivitis, Rhinoconjunctivitis
- What is being tested?
- Specific immunotherapy (SIT) treatment, Dietary Supplement: ABB C1 and Mini-tablets with pork extract
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 29 May 2024to 10 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Both sexes.
- Patients diagnosed with allergic rhinitis or allergic rhinoconjunctivitis, with or without allergic asthma due to sensitization to aeroallergens, undergoing treatment with subcutaneous polymerized 100 immunotherapy, initiating treatment with rapid dosing.
- Normoglycemia (fasting glucose ≤ 100 mg/dL).
- BMI between 18.5-29.9 kg/m².
Who cannot join
- Refusal to sign the informed consent.
- Outside the age range specified for the study.
- Presence of intolerance or hypersensitivity to selenium or zinc, or to any of the components of the dietary supplement individually.
- Participation in a clinical trial within the past two months, or currently participating in another study.
- Personal history of liver or kidney disease.
- Excessive alcohol consumption (\> 20 grams/day) or use of substance abuse.
- Any condition that, in the opinion of the investigators, renders the subject unable to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Dietary Supplement Based on a Synergistic Combination of Beta-Glucans and Saccharomyces Cerevisiae Yeast Enriched With Zinc and Selenium in Allergic Patients Undergoing Subcutaneous Immunotherapy Study.
The present study will attempt to determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, who are undergoing subcutaneous polymerized 100 immunotherapy with a rapid initiation protocol. It will also attempt to determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy.
Read the detailed description
The study\'s hypothesis is to verify whether the dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium is an immunomodulator of innate immunity with antioxidant properties that can strengthen and enhance the immune system response in allergic patients undergoing specific subcutaneous polymerized immunotherapy (ITE).
Its ingredients (beta-glucans, Saccharomyces cerevisiae yeast, selenium, and zinc) may provide patients with a balanced immune response during periods of seasonal stress as a result of increased levels of aeroallergens.
Histamine is a biogenic amine involved in numerous physiological systems, including allergic processes. Diamine oxidase (DAO) is an enzyme that metabolizes histamine. Pork kidney extract contains high amounts of DAO enzyme and is marketed for the management of various symptoms related to high levels of histamine in the blood. DAO deficiency has been associated with clinical manifestations of asthma and allergic rhinitis. The aim is to investigate whether DAO supplementation enhances the effect of a dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium in allergic patients undergoing specific subcutaneous polymerized immunotherapy (ITE).
This part of the study will be conducted in a separate and subsequent phase (follow-up) to the intake of the dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium alone.
The high tolerance, safety, and immediate bioavailability of this dietary supplement could provide beneficial effects on the immune system in an allergic population diagnosed with rhinitis or rhinoconjunctivitis, undergoing subcutaneous ITE treatment.
General Objective:
To determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, who are undergoing subcutaneous polymerized 100 immunotherapy with a rapid initiation protocol.
To determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy.
Primary Objective:
To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and subclasses: Total IgE, specific IgE, and IgG4 in serum.
Secondary Objectives:
Monitoring health status (quality of life) in the various phases of the study through the application of the SF-36 Quality of Life Questionnaire:
This questionnaire measures eight dimensions of health (physical functioning, role limitations due to physical problems, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality-energy-fatigue, and general health perception) in carrying out daily activities. Due to its validity, internal consistency, and reliability of the recorded data, the SF-36 questionnaire is a very useful tool in assessing the physical and mental health status of subjects and their progress in relation to the treatment.
Safety (evaluation during the various periods of the study after ingestion of the dietary supplement):
Recording of adverse events. If applicable, determining the causal relationship between the adverse event and the ingestion of the dietary supplement.
Assessment of the degree of satisfaction with the dietary supplement by the patient (TSQM questionnaire, Spanish version); and by both the doctor and the patient (simple Likert satisfaction scale).
Control of compliance/adherence to the treatment.
Evaluate the effectiveness of the combination of the dietary supplement and DAO extract on the immune response in allergic patients through the application of the SF-36 Quality of Life Questionnaire.
Study Design:
Multicenter, prospective, controlled, longitudinal, and randomized study conducted in the allergy clinics of the Extremadura Health Service (SES).
Study Population:
Sixty patients (n = 60) of both sexes, aged between 18 and 65 years, diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, undergoing subcutaneous polymerized 100 immunotherapy in the initiation phase with a rapid (cluster) protocol, in which the highest concentration of allergen (0.2 + 0.3 mL) is injected directly with an interval of 30 to 45 minutes between injections, in the allergy clinics of the SES.
All patients are required to have the ability to take the dietary supplement orally and to understand the process development for inclusion in the clinical study.
Eligibility Criteria:
Inclusion Criteria:
Age between 18 and 65 years. Both sexes. Patients diagnosed with allergic rhinitis or rhinoconjunctivitis, with or without allergic asthma due to sensitization to aeroallergens, undergoing subcutaneous polymerized 100 immunotherapy, initiating treatment with a rapid protocol.
Normoglycemia (fasting glucose ≤ 100 mg/dl). BMI between 18.5-29.9 kg/m².
Exclusion Criteria:
Not signing the informed consent. Not within the study age range. Intolerance or hypersensitivity to selenium or zinc, or to any components of the dietary supplement in isolation.
Participation in a clinical trial in the past two months or currently participating in another study.
Personal history of liver or kidney diseases. Excessive alcohol consumption (\> 20 g/day) or substance abuse. Any condition that, in the opinion of the investigators, disqualifies the subject from participating in the study.
Types of Intervention and Procedure:
All patients participating in the study are undergoing treatment with subcutaneous polymerized 100 immunotherapy in cluster format.
Patients will be randomly assigned to one of the two branches or groups in the study:
Experimental Group (n= 30): Participants receive the dietary supplement (1 sachet/day; containing 3 grams) in addition to ITE treatment, for 90 days.
Control Group (n= 30): Patients are undergoing ITE treatment but do not receive any dietary supplement, serving as a comparison for the study variables.
At the end of the first blinded phase of the study (90 days), all patients will have the opportunity to take ABB C1 openly (without a washout phase), but they will be randomized into two other groups:
Experimental Group (n= 30): Participants receive the dietary supplement (1 sachet/day; containing 3 grams) and mini-tablets with pig extract containing diamine oxidase enzyme (3 mini-tablets/day), in addition to ITE treatment, for 90 days.
Control Group (n= 30): Participants receive the dietary supplement (1 sachet/day; containing 3 grams), but do not receive pig extract with diamine oxidase enzyme, and serve as a comparison for the study variables.
Based on the available information provided by the manufacturer, the dietary supplement has the following composition (per 3-gram sachet): mannitol (bulking agent), beta 1,3/1,6 glucan polysaccharides from yeast (Saccharomyces cerevisiae); yeast Saccharomyces cerevisiae enriched with minerals (selenium and zinc); anhydrous citric acid (acidulant); lemon flavor; silicon dioxide (anticaking agent); sucralose (sweetener).
This dietary supplement is gluten-free, lactose-free, and suitable for vegans.
According to the available information provided by the manufacturer, the mini-tablets of DAO extract have the following composition: microcrystalline cellulose and hydroxypropyl cellulose (bulking agents); 7% kidney pork protein extract with diamine oxidase (DAO); ethylcellulose (coating agent), potato starch, medium-chain triglycerides, oleic acid, and stearic acid (stabilizers).
The study procedure is identical for all participants (n= 60) and consists of:
Baseline assessment (T0) and sample collection before the study. Intermediate assessment (T1) at 30 days. Intermediate assessment (T2) at 60 days. Final assessment (T3) and sample collection at 90 days. Follow-up: continuation of optional supplementation with ABB C1 for all volunteers who agree to take the product for an additional 90 days, including those who were previously randomized to the placebo group (follow-up study). These volunteers will be re-randomized and assigned to either the ABB C1® + DAO group or the ABB C1® group.
Final follow-up assessment (T4) and sample collection at 180 days.
- Conditions
- Rhinitis, Allergic Rhinoconjunctivitis, Rhinoconjunctivitis, Controlled Asthma, Uncontrolled Asthma
- Being tested
- Specific immunotherapy (SIT) treatment, Dietary Supplement: ABB C1, Mini-tablets with pork extract
- Keywords
- Rhinitis, Allergic rhinoconjunctivitis, Controlled asthma, Subcutaneous polymerized 100 cluster immunotherapy, Beta-glucans and yeast Saccharomyces cerevisiae, Subcutaneous immunotherapy, Multicenter study, Prospective study, Controlled group, Longitudinal study, Randomized study
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific immunotherapy (SIT) treatmentDrug
Also called Treatment with subcutaneous polymerized specific immunotherapy (ITE), allergen-specific immunotherapy (AIT)
Treatment with subcutaneous polymerized 100 specific immunotherapy (SIT) in its initiation phase with rapid (clustered) dosing, where the highest allergen concentration (0.2 + 0.3 mL) is administered directly, with an interval of 30 to 45 minutes between injections, in allergology consultations of the SES.
Dietary Supplement: ABB C1Dietary supplement
Ingredients: betaglucanos, levadura Saccharomyces cerevisiae, selenio y zinc.
1 sachet/day; contains 3 grams
Mini-tablets with pork extractDietary supplement
Mini-tablets with pork extract containing the diamine oxidase enzyme (3 mini-tablets/day)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Stage 1 (first 90 days) | Placebo comparator | Control group (n= 30):
Stage 1: Under treatment with subcutaneous immunotherapy (ITE) but not receiving any dietary supplement, serving as a comparison for the variables collected in the study, for 90 days. Receives: Drug: Specific immunotherapy (SIT) treatment |
| Dietary supplement Stage 1 (first 90 days) | Experimental | Experimental group (n= 30):
Stage 1: Participants receive the dietary supplement (1 sachet/day; contains 3 grams), in addition to the ITE treatment, for 90 days. Receives: Drug: Specific immunotherapy (SIT) treatment; Dietary Supplement: Dietary Supplement: ABB C1 |
| Placebo Stage 2 (last 90 days) | Placebo comparator | Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams), but they do not receive the pork extract with diamine oxidase enzyme and serve as a comparison for the variables collected in the study, for 90 days. Receives: Drug: Specific immunotherapy (SIT) treatment; Dietary Supplement: Dietary Supplement: ABB C1 |
| Dietary supplement Stage 2 (last 90 days) | Experimental | Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams) and mini-tablets with pork extract containing diamine oxidase enzyme (3 mini-tablets/day), for 90 days. Receives: Drug: Specific immunotherapy (SIT) treatment; Dietary Supplement: Dietary Supplement: ABB C1; Dietary Supplement: Mini-tablets with pork extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the dietary supplement
To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and IgE subclasses (Total IgE, specific IgE, and IgG4) in serum.
Measured: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
Secondary outcomes (5)
Monitoring of health status (quality of life) in the different phases of the study using the SF-36 Quality of Life Questionnaire.
This questionnaire measures eight dimensions of health (physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health). It assesses the impact of health conditions on daily activities. Due to its validity, internal consistency, and reliability of recorded data, the SF-36 questionnaire is highly useful in evaluating the physical and mental health status of subjects and their response to treatment.
Measured: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
Safety (assessment in the different study periods following intake of the dietary supplement)
Recording of adverse events. If applicable, determination of the causal relationship between the adverse event and the intake of the dietary supplement.
Measured: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
TSQM Spanish version questionnaire
Assessment of patient satisfaction with the dietary supplement (TSQM Spanish version questionnaire); and by both the physician and the patient (simple Likert scale of satisfaction).
Measured: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
• Monitoring treatment compliance/adherence.
- Monitoring treatment compliance/adherence.
Measured: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
SF-36 Quality of Life Questionnaire
To evaluate the effectiveness of the combination of the dietary supplement and DAO extract on the immune response in allergic patients using the SF-36 Quality of Life Questionnaire.
Measured: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start29 May 2024
- Primary completion29 May 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, controlled group, longitudinal, and randomized study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gala Servicios Clinicos S.L.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Antonio Carrillo, Medicine, Principal investigator, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448585
- Sponsor's protocol ID
- 90//2024
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Martin E, Garcia-Menaya J, Sanchez B, Martinez C, Rosendo R, Agundez JA. Polymorphisms of histamine-metabolizing enzymes and clinical manifestations of asthma and allergic rhinitis. Clin Exp Allergy. 2007 Aug;37(8):1175-82. doi: 10.1111/j.1365-2222.2007.02769.x.
PubMed 17651147Rodriguez JAM, Bifano M, Roca Goma E, Plasencia CM, Torralba AO, Font MS, Millan PR. Effect and Tolerability of a Nutritional Supplement Based on a Synergistic Combination of beta-Glucans and Selenium- and Zinc-Enriched Saccharomyces cerevisiae (ABB C1(R)) in Volunteers Receiving the Influenza or the COVID-19 Vaccine: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2021 Dec 2;13(12):4347. doi: 10.3390/nu13124347.
PubMed 34959898Calderon MA, Cox L, Casale TB, Moingeon P, Demoly P. Multiple-allergen and single-allergen immunotherapy strategies in polysensitized patients: looking at the published evidence. J Allergy Clin Immunol. 2012 Apr;129(4):929-34. doi: 10.1016/j.jaci.2011.11.019. Epub 2012 Jan 11.
PubMed 22244595
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Dietary Supplement Based on a Synergistic Combination of Beta-Glucans and Saccharomyces Cerevisiae Yeast Enriched With Zinc and Selenium in Allergic Patients Undergoing Subcutaneous Immunotherapy Study.
- ClinicalTrials.gov ID
- NCT06448585
- Acronym / sponsor ID
- 90//2024
- Conditions
- Rhinitis, Allergic Rhinoconjunctivitis, Rhinoconjunctivitis, Controlled Asthma, Uncontrolled Asthma
- Keywords
- Rhinitis, Allergic rhinoconjunctivitis, Controlled asthma, Subcutaneous polymerized 100 cluster immunotherapy, Beta-glucans and yeast Saccharomyces cerevisiae, Subcutaneous immunotherapy, Multicenter study, Prospective study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gala Servicios Clinicos S.L.University, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will attempt to determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, who are undergoing subcutaneous polymerized 100 immunotherapy with a rapid initiation protocol. It will also attempt to determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy.
Detailed description
The study\'s hypothesis is to verify whether the dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium is an immunomodulator of innate immunity with antioxidant properties that can strengthen and enhance the immune system response in allergic patients undergoing specific subcutaneous polymerized immunotherapy (ITE).
Its ingredients (beta-glucans, Saccharomyces cerevisiae yeast, selenium, and zinc) may provide patients with a balanced immune response during periods of seasonal stress as a result of increased levels of aeroallergens.
Histamine is a biogenic amine involved in numerous physiological systems, including allergic processes. Diamine oxidase (DAO) is an enzyme that metabolizes histamine. Pork kidney extract contains high amounts of DAO enzyme and is marketed for the management of various symptoms related to high levels of histamine in the blood. DAO deficiency has been associated with clinical manifestations of asthma and allergic rhinitis. The aim is to investigate whether DAO supplementation enhances the effect of a dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium in allergic patients undergoing specific subcutaneous polymerized immunotherapy (ITE).
This part of the study will be conducted in a separate and subsequent phase (follow-up) to the intake of the dietary supplement based on a synergistic combination of Beta-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium alone.
The high tolerance, safety, and immediate bioavailability of this dietary supplement could provide beneficial effects on the immune system in an allergic population diagnosed with rhinitis or rhinoconjunctivitis, undergoing subcutaneous ITE treatment.
General Objective:
To determine if the dietary supplement, based on a synergistic combination of β-glucans and Saccharomyces cerevisiae yeast enriched with Zinc and Selenium, can improve the immune response in allergic patients diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, who are undergoing subcutaneous polymerized 100 immunotherapy with a rapid initiation protocol.
To determine if the dietary supplement in combination with DAO enzyme could improve the immunological response to immunotherapy.
Primary Objective:
To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and subclasses: Total IgE, specific IgE, and IgG4 in serum.
Secondary Objectives:
Monitoring health status (quality of life) in the various phases of the study through the application of the SF-36 Quality of Life Questionnaire:
This questionnaire measures eight dimensions of health (physical functioning, role limitations due to physical problems, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality-energy-fatigue, and general health perception) in carrying out daily activities. Due to its validity, internal consistency, and reliability of the recorded data, the SF-36 questionnaire is a very useful tool in assessing the physical and mental health status of subjects and their progress in relation to the treatment.
Safety (evaluation during the various periods of the study after ingestion of the dietary supplement):
Recording of adverse events. If applicable, determining the causal relationship between the adverse event and the ingestion of the dietary supplement.
Assessment of the degree of satisfaction with the dietary supplement by the patient (TSQM questionnaire, Spanish version); and by both the doctor and the patient (simple Likert satisfaction scale).
Control of compliance/adherence to the treatment.
Evaluate the effectiveness of the combination of the dietary supplement and DAO extract on the immune response in allergic patients through the application of the SF-36 Quality of Life Questionnaire.
Study Design:
Multicenter, prospective, controlled, longitudinal, and randomized study conducted in the allergy clinics of the Extremadura Health Service (SES).
Study Population:
Sixty patients (n = 60) of both sexes, aged between 18 and 65 years, diagnosed with rhinitis or rhinoconjunctivitis, with or without controlled asthma, undergoing subcutaneous polymerized 100 immunotherapy in the initiation phase with a rapid (cluster) protocol, in which the highest concentration of allergen (0.2 + 0.3 mL) is injected directly with an interval of 30 to 45 minutes between injections, in the allergy clinics of the SES.
All patients are required to have the ability to take the dietary supplement orally and to understand the process development for inclusion in the clinical study.
Eligibility Criteria:
Inclusion Criteria:
Age between 18 and 65 years. Both sexes. Patients diagnosed with allergic rhinitis or rhinoconjunctivitis, with or without allergic asthma due to sensitization to aeroallergens, undergoing subcutaneous polymerized 100 immunotherapy, initiating treatment with a rapid protocol.
Normoglycemia (fasting glucose ≤ 100 mg/dl). BMI between 18.5-29.9 kg/m².
Exclusion Criteria:
Not signing the informed consent. Not within the study age range. Intolerance or hypersensitivity to selenium or zinc, or to any components of the dietary supplement in isolation.
Participation in a clinical trial in the past two months or currently participating in another study.
Personal history of liver or kidney diseases. Excessive alcohol consumption (\> 20 g/day) or substance abuse. Any condition that, in the opinion of the investigators, disqualifies the subject from participating in the study.
Types of Intervention and Procedure:
All patients participating in the study are undergoing treatment with subcutaneous polymerized 100 immunotherapy in cluster format.
Patients will be randomly assigned to one of the two branches or groups in the study:
Experimental Group (n= 30): Participants receive the dietary supplement (1 sachet/day; containing 3 grams) in addition to ITE treatment, for 90 days.
Control Group (n= 30): Patients are undergoing ITE treatment but do not receive any dietary supplement, serving as a comparison for the study variables.
At the end of the first blinded phase of the study (90 days), all patients will have the opportunity to take ABB C1 openly (without a washout phase), but they will be randomized into two other groups:
Experimental Group (n= 30): Participants receive the dietary supplement (1 sachet/day; containing 3 grams) and mini-tablets with pig extract containing diamine oxidase enzyme (3 mini-tablets/day), in addition to ITE treatment, for 90 days.
Control Group (n= 30): Participants receive the dietary supplement (1 sachet/day; containing 3 grams), but do not receive pig extract with diamine oxidase enzyme, and serve as a comparison for the study variables.
Based on the available information provided by the manufacturer, the dietary supplement has the following composition (per 3-gram sachet): mannitol (bulking agent), beta 1,3/1,6 glucan polysaccharides from yeast (Saccharomyces cerevisiae); yeast Saccharomyces cerevisiae enriched with minerals (selenium and zinc); anhydrous citric acid (acidulant); lemon flavor; silicon dioxide (anticaking agent); sucralose (sweetener).
This dietary supplement is gluten-free, lactose-free, and suitable for vegans.
According to the available information provided by the manufacturer, the mini-tablets of DAO extract have the following composition: microcrystalline cellulose and hydroxypropyl cellulose (bulking agents); 7% kidney pork protein extract with diamine oxidase (DAO); ethylcellulose (coating agent), potato starch, medium-chain triglycerides, oleic acid, and stearic acid (stabilizers).
The study procedure is identical for all participants (n= 60) and consists of:
Baseline assessment (T0) and sample collection before the study. Intermediate assessment (T1) at 30 days. Intermediate assessment (T2) at 60 days. Final assessment (T3) and sample collection at 90 days. Follow-up: continuation of optional supplementation with ABB C1 for all volunteers who agree to take the product for an additional 90 days, including those who were previously randomized to the placebo group (follow-up study). These volunteers will be re-randomized and assigned to either the ABB C1® + DAO group or the ABB C1® group.
Final follow-up assessment (T4) and sample collection at 180 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Multicenter, prospective, controlled group, longitudinal, and randomized study
| Arm | Type | Receives |
|---|---|---|
| Placebo Stage 1 (first 90 days) | Placebo comparator | Drug: Specific immunotherapy (SIT) treatmentControl group (n= 30): Stage 1: Under treatment with subcutaneous immunotherapy (ITE) but not receiving any dietary supplement, serving as a comparison for the variables collected in the study, for 90 days. |
| Dietary supplement Stage 1 (first 90 days) | Experimental | Drug: Specific immunotherapy (SIT) treatment, Dietary Supplement: Dietary Supplement: ABB C1Experimental group (n= 30): Stage 1: Participants receive the dietary supplement (1 sachet/day; contains 3 grams), in addition to the ITE treatment, for 90 days. |
| Placebo Stage 2 (last 90 days) | Placebo comparator | Drug: Specific immunotherapy (SIT) treatment, Dietary Supplement: Dietary Supplement: ABB C1Stage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams), but they do not receive the pork extract with diamine oxidase enzyme and serve as a comparison for the variables collected in the study, for 90 days. |
| Dietary supplement Stage 2 (last 90 days) | Experimental | Drug: Specific immunotherapy (SIT) treatment, Dietary Supplement: Dietary Supplement: ABB C1, Dietary Supplement: Mini-tablets with pork extractStage 2: In addition to the ITE treatment, they receive the dietary supplement (1 sachet/day; contains 3 grams) and mini-tablets with pork extract containing diamine oxidase enzyme (3 mini-tablets/day), for 90 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years.
- Both sexes.
- Patients diagnosed with allergic rhinitis or allergic rhinoconjunctivitis, with or without allergic asthma due to sensitization to aeroallergens, undergoing treatment with subcutaneous polymerized 100 immunotherapy, initiating treatment with rapid dosing.
- Normoglycemia (fasting glucose ≤ 100 mg/dL).
- BMI between 18.5-29.9 kg/m².
Key exclusion criteria (7 listed)
- Refusal to sign the informed consent.
- Outside the age range specified for the study.
- Presence of intolerance or hypersensitivity to selenium or zinc, or to any of the components of the dietary supplement individually.
- Participation in a clinical trial within the past two months, or currently participating in another study.
- Personal history of liver or kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific immunotherapy (SIT) treatmentAlso: Treatment with subcutaneous polymerized specific immunotherapy (ITE), allergen-specific immunotherapy (AIT)Treatment with subcutaneous polymerized 100 specific immunotherapy (SIT) in its initiation phase with rapid (clustered) dosing, where the highest allergen concentration (0.2 + 0.3 mL) is administered directly, with an interval of 30 to 45 minutes between injections, in allergology consultations of the SES. | Drug | Dietary supplement Stage 1 (first 90 days), Dietary supplement Stage 2 (last 90 days), Placebo Stage 1 (first 90 days), Placebo Stage 2 (last 90 days) |
| Dietary Supplement: ABB C1Ingredients: betaglucanos, levadura Saccharomyces cerevisiae, selenio y zinc. 1 sachet/day; contains 3 grams | Dietary supplement | Dietary supplement Stage 1 (first 90 days), Dietary supplement Stage 2 (last 90 days), Placebo Stage 2 (last 90 days) |
| Mini-tablets with pork extractMini-tablets with pork extract containing the diamine oxidase enzyme (3 mini-tablets/day) | Dietary supplement | Dietary supplement Stage 2 (last 90 days) |
Primary outcome
Effectiveness of the dietary supplement
Time frame: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
To evaluate the effectiveness of the dietary supplement on the immune response in allergic patients by determining the levels of immunoglobulins and IgE subclasses (Total IgE, specific IgE, and IgG4) in serum.
5 secondary outcomes
Monitoring of health status (quality of life) in the different phases of the study using the SF-36 Quality of Life Questionnaire.
Time frame: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
Safety (assessment in the different study periods following intake of the dietary supplement)
Time frame: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
TSQM Spanish version questionnaire
Time frame: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
• Monitoring treatment compliance/adherence.
Time frame: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
SF-36 Quality of Life Questionnaire
Time frame: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 17651147Garcia-Martin E, Garcia-Menaya J, Sanchez B, Martinez C, Rosendo R, Agundez JA. Polymorphisms of histamine-metabolizing enzymes and clinical manifestations of asthma and allergic rhinitis. Clin Exp Allergy. 2007 Aug;37(8):1175-82. doi: 10.1111/j.1365-2222.2007.02769.x.
- Background: PubMed 34959898Rodriguez JAM, Bifano M, Roca Goma E, Plasencia CM, Torralba AO, Font MS, Millan PR. Effect and Tolerability of a Nutritional Supplement Based on a Synergistic Combination of beta-Glucans and Selenium- and Zinc-Enriched Saccharomyces cerevisiae (ABB C1(R)) in Volunteers Receiving the Influenza or the COVID-19 Vaccine: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2021 Dec 2;13(12):4347. doi: 10.3390/nu13124347.
- Background: PubMed 22244595Calderon MA, Cox L, Casale TB, Moingeon P, Demoly P. Multiple-allergen and single-allergen immunotherapy strategies in polysensitized patients: looking at the published evidence. J Allergy Clin Immunol. 2012 Apr;129(4):929-34. doi: 10.1016/j.jaci.2011.11.019. Epub 2012 Jan 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Antonio Carrillo, Medicine principal investigator
Universidad de Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Specific immunotherapy (SIT) treatment, Dietary Supplement: ABB C1 and Mini-tablets with pork extract in people with Rhinitis and Allergic Rhinoconjunctivitis, run by Gala Servicios Clinicos S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the dietary supplement (time frame: (T0) before the study. (T1) at 30 days. (T2) at 60 days. (T3) and sample collection at 90 days. (T4) and sample collection at 180 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06448585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.