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

University of Florida224 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

224

Conditions

Healthy

Interventions

Probiotic mixtureDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: up to 8 weeks from date of randomization

Secondary Outcomes

Serum Total Immunoglobulin E (IgE)

Serum total immunoglobulin E (IgE) was quantified via ELISA

Time frame: 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.

Time frame: 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

Time frame: baseline and week 6

Data from ClinicalTrials.gov

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