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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic mixture

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.
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).	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.; Other Names: Kyo-Dophilus; Lactobacillus gasseri KS-13; Bifidobacterium bifidum G9-1; Bifidobacterium longum MM-2

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Wakunaga Pharmaceutical Co., Ltd.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (ESTIMATE): January 29, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: probiotic; immune; allergy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Hypersensitivity; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: IRB201400894; Project No. 00120905 (OTHER: Wakunaga Pharmaceutical Co., Ltd.)