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

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2015

Interventions

  • Dietary Supplement: Probiotic mixture
    • 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.
  • Dietary Supplement: 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). Supplement contains 348.25 mg of potato starch.

Arms, Groups and Cohorts

  • Placebo Comparator: 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).
  • Experimental: 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • Serum Total Immunoglobulin E (IgE)
    • Time Frame: baseline and week 6
    • Serum total immunoglobulin E (IgE) was quantified via ELISA
  • Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire
    • Time Frame: 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.
  • Regulatory T Cells (Tregs)
    • Time Frame: baseline and week 6
    • Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • Wakunaga Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bobbi Langkamp-Henken, PhD, RD, Principal Investigator, University of Florida

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