HealthyJENNCT02349711
Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies
A study testing Probiotic mixture in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
In this randomized, double-blind, placebo-controlled study, participants with seasonal allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse events, and compliance. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be included if they:
- are 18 to 60 years of age (inclusive).
- receive a score of 2 or greater on the Mini Rhinoconjunctivitis Quality of Life Questionnaire.
- are willing and able to complete the Informed Consent Form in English.
- are available for 8 consecutive weeks to participate in this study.
- be willing and able to complete online daily and weekly questionnaires regarding general wellness, bowel function, quality of life, gastrointestinal symptoms, and physical activity.
Show all 10Show fewer
- are willing and able to maintain their regular level of physical activity and diet for the 8-week study.
- are able to take the study supplement without the aid of another person.
- are willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements), or immune-enhancing supplements (e.g., Echinacea or fish oil).
- are willing to provide 2 blood and 2 stool samples (subgroup only).
Who cannot join
- Subjects will be excluded if they:
- do not meet any of the above criteria.
- use allergy medications, including nasal sprays, 5 or more days per week.
- receive allergy shots.
- are currently pregnant or attempting to get pregnant.
- are currently taking any systemic corticosteroids, androgens (such as testosterone), or large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
- are currently being treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer, etc.); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including GERD; or have a central venous catheter.
- have received chemotherapy or other immune suppressing therapy within the last year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) and Health-related Quality of Life in Individuals With Seasonal Allergies
In this randomized, double-blind, placebo-controlled study, participants with seasonal allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse events, and compliance. In a subset of subjects, stool and blood samples will be collected at baseline and at week 6 of the intervention (estimated to be peak allergy season) to characterize microbial communities and immune function.
- Conditions
- Healthy
- Being tested
- Probiotic mixture, Placebo
- Keywords
- probiotic, allergy, immune
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mixtureDietary supplement
Also called Kyo-Dophilus, Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2
A 350 mg capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.
PlaceboDietary supplement
Placebo will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Receives: Dietary Supplement: Placebo |
| Probiotic mixture | Experimental | A commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Receives: Dietary Supplement: Probiotic mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ
MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)
Measured: up to 8 weeks from date of randomization
Secondary outcomes (3)
Serum Total Immunoglobulin E (IgE)
Serum total immunoglobulin E (IgE) was quantified via ELISA
Measured: baseline and week 6
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire
Symptoms included in this score are constipation, hard stools, and feeling of incomplete evacuation reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire. Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.
Measured: weeks 0, 1, 2, 3, 4, 5, 6, 7
Regulatory T Cells (Tregs)
Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry
Measured: baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bobbi Langkamp-Henken, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349711
- Sponsor's protocol ID
- IRB201400894
- Other IDs
- Project No. 00120905
- Acronym
- JEN
- Status last verified
- May 2017
- First submitted
- 23 Jan 2015
- Last updated
- 9 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dennis-Wall JC, Culpepper T, Nieves C Jr, Rowe CC, Burns AM, Rusch CT, Federico A, Ukhanova M, Waugh S, Mai V, Christman MC, Langkamp-Henken B. Probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2) improve rhinoconjunctivitis-specific quality of life in individuals with seasonal allergies: a double-blind, placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Mar;105(3):758-767. doi: 10.3945/ajcn.116.140012. Epub 2017 Feb 22.
PubMed 28228426
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) and Health-related Quality of Life in Individuals With Seasonal Allergies
- ClinicalTrials.gov ID
- NCT02349711
- Acronym / sponsor ID
- JEN / IRB201400894
- Conditions
- Healthy
- Keywords
- probiotic, allergy, immune
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Wakunaga Pharmaceutical Co., Ltd.
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Posted 31 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized, double-blind, placebo-controlled study, participants with seasonal allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse events, and compliance. In a subset of subjects, stool and blood samples will be collected at baseline and at week 6 of the intervention (estimated to be peak allergy season) to characterize microbial communities and immune function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
| Probiotic mixture | Experimental | Dietary Supplement: Probiotic mixtureA commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- are 18 to 60 years of age (inclusive).
- receive a score of 2 or greater on the Mini Rhinoconjunctivitis Quality of Life Questionnaire.
- are willing and able to complete the Informed Consent Form in English.
- are available for 8 consecutive weeks to participate in this study.
- be willing and able to complete online daily and weekly questionnaires regarding general wellness, bowel function, quality of life, gastrointestinal symptoms, and physical activity.
Key exclusion criteria (8 listed)
- do not meet any of the above criteria.
- use allergy medications, including nasal sprays, 5 or more days per week.
- receive allergy shots.
- are currently pregnant or attempting to get pregnant.
- are currently taking any systemic corticosteroids, androgens (such as testosterone), or large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
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 |
|---|---|---|
| Probiotic mixtureAlso: Kyo-Dophilus, Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2A 350 mg capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica. | Dietary supplement | Probiotic mixture |
| PlaceboPlacebo will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Supplement contains 348.25 mg of potato starch. | Dietary supplement | Placebo |
Primary outcome
Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ
Time frame: up to 8 weeks from date of randomization
MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)
3 secondary outcomes
Serum Total Immunoglobulin E (IgE)
Time frame: baseline and week 6
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire
Time frame: weeks 0, 1, 2, 3, 4, 5, 6, 7
Regulatory T Cells (Tregs)
Time frame: baseline and week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28228426Dennis-Wall JC, Culpepper T, Nieves C Jr, Rowe CC, Burns AM, Rusch CT, Federico A, Ukhanova M, Waugh S, Mai V, Christman MC, Langkamp-Henken B. Probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2) improve rhinoconjunctivitis-specific quality of life in individuals with seasonal allergies: a double-blind, placebo-controlled, randomized trial. Am J Clin Nutr. 2017 Mar;105(3):758-767. doi: 10.3945/ajcn.116.140012. Epub 2017 Feb 22.
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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.
Bobbi Langkamp-Henken, PhD, RD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic mixture in people with Healthy, run by University of Florida at 1 site in United States.
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 10 inclusion and 8 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 9 Jun 2017. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ (time frame: up to 8 weeks from date of randomization). 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 NCT02349711, which also lists 1 linked publication.
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 9 Jun 2017.