Celiac DiseaseGalacNCT07831408
Study On The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Disorders
A study testing Galactol® in people with Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial summary
The aim of this randomized, double-blind, placebo-controlled interventional study is to evaluate the efficacy of Galactol® in adult patients aged 18 to 70 years with celiac disease and functional abdominal bloating. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Galactol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have provided written informed consent
- Age: 18-70 years
- Patients with celiac disease and functional abdominal bloating
Who cannot join
- Women who are pregnant or breastfeeding
- Patients intolerant to one or more components of Galactol®/placebo
- Patients allergic to one or more components of Galactol®/placebo
About this study
Official title: Randomized Double-Blind Interventional Study To Evaluate The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Pain
The aim of this randomized, double-blind, placebo-controlled interventional study is to evaluate the efficacy of Galactol® in adult patients aged 18 to 70 years with celiac disease and functional abdominal bloating.
The main question the study aims to answer is:
Read more
Does Galactol® improve the overall well-being of patients with celiac disease and functional abdominal bloating? Researchers will compare a group taking Galactol® with a group taking a placebo to determine whether the treatment leads to an improvement in overall well-being and gastrointestinal symptoms.
Participants will: be randomly assigned to either the Galactol® group or the placebo group; take the assigned product for 30 days; complete questionnaires and assessment scales to evaluate overall well-being, gastrointestinal symptoms, quality of life, mental health, and adherence to a gluten-free diet; undergo 5 mL blood draws before and after treatment to measure IL-10 and TNF-α levels; attend an initial visit and a visit after 30 days of treatment, during which tolerability, compliance, and any adverse events will also be assessed.
Read the detailed description
The study is designed as a non-pharmacological interventional clinical investigation aimed at evaluating the effect of a food supplement on overall well-being and gastrointestinal symptoms in adult subjects with celiac disease (CD) and functional abdominal bloating. The study design involves a comparison between the intake of Galactol® and a placebo, with treatment effects assessed using clinical tools and validated questionnaires, as well as through the measurement of specific blood biomarkers.
The primary objective is to determine whether the intervention results in an improvement in patients' perceived overall well-being over a 30-day period compared with baseline, and whether any such improvement differs from that observed in subjects receiving the placebo.
A total of 50 adult patients are expected to be enrolled. Participants will be randomly assigned to the treatments in a 1:1 ratio and will therefore be allocated to two groups of comparable size: intervention group, receiving treatment with Galactol®; placebo group, receiving the placebo product. The intervention group will receive Galactol®, a food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase. The treatment will be administered for 30 days as follows: 2 tablets at the beginning of lunch; 2 tablets at the beginning of dinner.
The control group will receive a placebo with characteristics corresponding to those of the active product and with identical administration schedules and timing. The use of a placebo is intended, as far as possible, to distinguish the specific effect of the supplement from non-specific effects associated with participation in the study, the attention received from healthcare staff, and participants' expectations.
Each participant will take part in three main study visits: a screening visit, a baseline visit and a visit at the end of the treatment period. Screening visit (T0):
During this visit, the patient will be informed about the possibility of taking part in the study and will receive information about its purpose, procedures and duration. Participation will be voluntary and will require the participant to provide written informed consent. Only eligible participants will proceed to the baseline visit. Baseline visit (T1): The T1 visit will take place within 7 days of the screening visit. During this visit, information about the participant's health and general characteristics will be collected, including age, sex, body mass index, available blood test results and medical history. A nutritional assessment will also be performed, including a dietary history and anthropometric measurements. Particular attention will be paid to adherence to the gluten-free diet (GFD), as this may influence gastrointestinal symptoms and the results of the study. Before treatment begins, a small blood sample (5 mL) will be collected specifically for the study. The sample will be used to measure IL-10 and TNF-α levels. Overall well-being will be assessed using a visual analogue scale (VAS) from 0 to 10, allowing participants to indicate how satisfied they are with their overall well-being. Gastrointestinal symptoms will be assessed using VAS scales from 0 to 10, covering abdominal pain, stool consistency, abdominal bloating, post-meal fullness, early satiety and epigastric burning. Higher scores indicate more severe symptoms. Quality of life will be assessed using the SF-36 questionnaire, while mental health symptoms will be evaluated using the Symptom Checklist-90-R (SCL-90). Adherence to the gluten-free diet will be assessed using the CDAT questionnaire. End-of-treatment visit (T2): The T2 visit will take place after 30 days of treatment. The purpose of this visit is to assess any changes compared with the participant's baseline condition. The assessments of overall well-being, gastrointestinal symptoms, quality of life and mental health will therefore be repeated using the same questionnaires and scales used at T1. Adherence to the gluten-free diet will also be reassessed to determine whether it has remained stable throughout the treatment period. A second 5 mL blood sample will be collected to measure IL-10 and TNF-α levels. These results will be compared with the baseline measurements to assess any changes during the treatment period.
- Conditions
- Celiac Disease
- Being tested
- Galactol®, Placebo
- Keywords
- Celiac disease, Functional abdominal bloating, Abdominal bloating, Gluten-free diet, Food supplement
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galactol®Dietary supplement
A food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase.
PlaceboOther
The composition of the placebo product will be qualitatively the same as that of the verum product, but without the active components under investigation
| Study group | Role | What they receive |
|---|---|---|
| Galactol Group | Active comparator | Galactol group, receiving treatment with Galactol® Receives: Dietary Supplement: Galactol® |
| Placebo group | Placebo comparator | Placebo group, receiving the placebo product Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
The primary endpoint is the quantitative change in the patient's overall well-being, assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores indicating better well-being. The change in VAS score will be calculated as the difference between the post-treatment visit (T2) and the baseline visit (T1) (T2-T1) in both groups. The change in VAS score will be compared between the treatment group and the placebo group.
Measured: 30 days (T1 to T2)
Secondary outcomes (9)
Abdominal pain
Abdominal pain will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates absence of the symptom and 10 indicates a very severe symptom. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
Measured: 30 days (T1 to T2)
Abdominal bloating
Abdominal bloating will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no abdominal bloating and 10 indicates very severe abdominal bloating. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
Measured: 30 days (T1 to T2)
Satisfaction with stool consistency
Satisfaction with stool consistency will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates complete dissatisfaction with stool consistency and 10 indicates very high satisfaction. Higher scores indicate greater satisfaction with stool consistency. The absolute change between T1 and T2 will be analyzed. An increase in the score between T1 and T2 will indicate an improvement in satisfaction with stool consistency.
Measured: 30 days (T1 to T2)
Postprandial fullness severity
The severity of postprandial fullness will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no postprandial fullness and 10 indicates very severe postprandial fullness. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
Measured: 30 days (T1 to T2)
Severity of early satiety
The severity of early satiety will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no early satiety and 10 indicates very severe early satiety. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
Measured: 30 days (T1 to T2)
Gastric burning severity
The severity of gastric burning will be assessed using a 10-cm Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates no gastric burning and 10 indicates very severe gastric burning. Higher scores indicate greater symptom severity. The absolute change between T1 and T2 will be analyzed. A reduction of ≥3 cm will be considered a clinically relevant improvement.
Measured: 30 days (T1 to T2)
Improvement in quality of life and mental health
Quality of life will be assessed before and after treatment using the 36-Item Short Form Health Survey (SF-36), with comparison of the scores obtained at T1 and T2. An increase in the score between T1 and T2 (T2-T1 > 0) will be interpreted as indicative of an improvement in perceived quality of life.
Measured: 30 days (T1 to T2)
Improvement in quality of life and mental health
Psychological distress will be assessed before and after treatment using the Symptom Checklist-90 (SCL-90), with comparison of the scores obtained at T1 and T2. Since higher scores reflect a higher level of psychological distress, a reduction in the score between T1 and T2 (T2-T1 < 0) will be interpreted as indicative of an improvement.
Measured: 30 days (from T1 to T2)
Intestinal permeability indicators
Quantification of the pre- and post-treatment changes in plasma concentrations of IL-10 (pg/mL) and TNF-α (pg/mL).
Measured: 30 days (T1 to T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- PharmExtracta S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831408
- Sponsor's protocol ID
- ID6919
- Acronym
- Galac
- Status last verified
- Jun 2026
- First submitted
- 1 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Interventional Study To Evaluate The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Pain
- ClinicalTrials.gov ID
- NCT07831408
- Acronym / sponsor ID
- Galac / ID6919
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Functional abdominal bloating, Abdominal bloating, Gluten-free diet, Food supplement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- PharmExtracta S.p.A.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Sep 2026 (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 aim of this randomized, double-blind, placebo-controlled interventional study is to evaluate the efficacy of Galactol® in adult patients aged 18 to 70 years with celiac disease and functional abdominal bloating.
The main question the study aims to answer is:
Does Galactol® improve the overall well-being of patients with celiac disease and functional abdominal bloating? Researchers will compare a group taking Galactol® with a group taking a placebo to determine whether the treatment leads to an improvement in overall well-being and gastrointestinal symptoms.
Participants will: be randomly assigned to either the Galactol® group or the placebo group; take the assigned product for 30 days; complete questionnaires and assessment scales to evaluate overall well-being, gastrointestinal symptoms, quality of life, mental health, and adherence to a gluten-free diet; undergo 5 mL blood draws before and after treatment to measure IL-10 and TNF-α levels; attend an initial visit and a visit after 30 days of treatment, during which tolerability, compliance, and any adverse events will also be assessed.
Detailed description
The study is designed as a non-pharmacological interventional clinical investigation aimed at evaluating the effect of a food supplement on overall well-being and gastrointestinal symptoms in adult subjects with celiac disease (CD) and functional abdominal bloating. The study design involves a comparison between the intake of Galactol® and a placebo, with treatment effects assessed using clinical tools and validated questionnaires, as well as through the measurement of specific blood biomarkers.
The primary objective is to determine whether the intervention results in an improvement in patients' perceived overall well-being over a 30-day period compared with baseline, and whether any such improvement differs from that observed in subjects receiving the placebo.
A total of 50 adult patients are expected to be enrolled. Participants will be randomly assigned to the treatments in a 1:1 ratio and will therefore be allocated to two groups of comparable size: intervention group, receiving treatment with Galactol®; placebo group, receiving the placebo product. The intervention group will receive Galactol®, a food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase. The treatment will be administered for 30 days as follows: 2 tablets at the beginning of lunch; 2 tablets at the beginning of dinner.
The control group will receive a placebo with characteristics corresponding to those of the active product and with identical administration schedules and timing. The use of a placebo is intended, as far as possible, to distinguish the specific effect of the supplement from non-specific effects associated with participation in the study, the attention received from healthcare staff, and participants' expectations.
Each participant will take part in three main study visits: a screening visit, a baseline visit and a visit at the end of the treatment period. Screening visit (T0):
During this visit, the patient will be informed about the possibility of taking part in the study and will receive information about its purpose, procedures and duration. Participation will be voluntary and will require the participant to provide written informed consent. Only eligible participants will proceed to the baseline visit. Baseline visit (T1): The T1 visit will take place within 7 days of the screening visit. During this visit, information about the participant's health and general characteristics will be collected, including age, sex, body mass index, available blood test results and medical history. A nutritional assessment will also be performed, including a dietary history and anthropometric measurements. Particular attention will be paid to adherence to the gluten-free diet (GFD), as this may influence gastrointestinal symptoms and the results of the study. Before treatment begins, a small blood sample (5 mL) will be collected specifically for the study. The sample will be used to measure IL-10 and TNF-α levels. Overall well-being will be assessed using a visual analogue scale (VAS) from 0 to 10, allowing participants to indicate how satisfied they are with their overall well-being. Gastrointestinal symptoms will be assessed using VAS scales from 0 to 10, covering abdominal pain, stool consistency, abdominal bloating, post-meal fullness, early satiety and epigastric burning. Higher scores indicate more severe symptoms. Quality of life will be assessed using the SF-36 questionnaire, while mental health symptoms will be evaluated using the Symptom Checklist-90-R (SCL-90). Adherence to the gluten-free diet will be assessed using the CDAT questionnaire. End-of-treatment visit (T2): The T2 visit will take place after 30 days of treatment. The purpose of this visit is to assess any changes compared with the participant's baseline condition. The assessments of overall well-being, gastrointestinal symptoms, quality of life and mental health will therefore be repeated using the same questionnaires and scales used at T1. Adherence to the gluten-free diet will also be reassessed to determine whether it has remained stable throughout the treatment period. A second 5 mL blood sample will be collected to measure IL-10 and TNF-α levels. These results will be compared with the baseline measurements to assess any changes during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galactol Group | Active comparator | Dietary Supplement: Galactol®Galactol group, receiving treatment with Galactol® |
| Placebo group | Placebo comparator | Other: PlaceboPlacebo group, receiving the placebo product |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have provided written informed consent
- Age: 18-70 years
- Patients with celiac disease and functional abdominal bloating
Key exclusion criteria (3 listed)
- Women who are pregnant or breastfeeding
- Patients intolerant to one or more components of Galactol®/placebo
- Patients allergic to one or more components of Galactol®/placebo
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 |
|---|---|---|
| Galactol®A food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase. | Dietary supplement | Galactol Group |
| PlaceboThe composition of the placebo product will be qualitatively the same as that of the verum product, but without the active components under investigation | Other | Placebo group |
Primary outcome
Primary endpoint
Time frame: 30 days (T1 to T2)
The primary endpoint is the quantitative change in the patient's overall well-being, assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores indicating better well-being. The change in VAS score will be calculated as the difference between the post-treatment visit (T2) and the baseline visit (T1) (T2-T1) in both groups. The change in VAS score will be compared between the treatment group and the placebo group.
9 secondary outcomes
Abdominal pain
Time frame: 30 days (T1 to T2)
Abdominal bloating
Time frame: 30 days (T1 to T2)
Satisfaction with stool consistency
Time frame: 30 days (T1 to T2)
Postprandial fullness severity
Time frame: 30 days (T1 to T2)
Severity of early satiety
Time frame: 30 days (T1 to T2)
Gastric burning severity
Time frame: 30 days (T1 to T2)
Improvement in quality of life and mental health
Time frame: 30 days (T1 to T2)
Improvement in quality of life and mental health
Time frame: 30 days (from T1 to T2)
Intestinal permeability indicators
Time frame: 30 days (T1 to T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Galactol® in people with Celiac Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Primary endpoint (time frame: 30 days (T1 to T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.