Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies

Study Overview
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Brief Summary
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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.

Official Title
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Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) and Health-related Quality of Life in Individuals With Seasonal Allergies

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Probiotic mixture
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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). | Dietary Supplement: Placebo<br>* 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.<br>|
| Experimental: Probiotic mixture<br>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). | Dietary Supplement: Probiotic mixture<br>* 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.<br>* Other names: Bifidobacterium longum MM-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 8 weeks from date of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Total Immunoglobulin E (IgE) | Serum total immunoglobulin E (IgE) was quantified via ELISA | 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. | 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 | baseline and week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotic, allergy, immune