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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotic mixture

• Registration Number: NCT02349711
• Lead Sponsor: University of Florida

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-01-29
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-05-24
• Results First Submitted QC: 2016-07-19
• Results First Posted: 2016-08-31
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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).
Probiotic mixture	Probiotic mixture	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).

Primary Outcome Measures

Name	Time	Method
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	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)

Secondary Outcome Measures

Name	Time	Method
Regulatory T Cells (Tregs)	baseline and week 6	Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry
Serum Total Immunoglobulin E (IgE)	baseline and week 6	Serum total immunoglobulin E (IgE) was quantified via ELISA
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire	weeks 0, 1, 2, 3, 4, 5, 6, 7	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States