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

• ClinicalTrials.gov Identifier: NCT02349711
• Recruitment Status: Completed
• First Posted: January 29, 2015
• Results First Posted: August 31, 2016
• Last Update Posted: June 9, 2017
• Sponsor: University of Florida
• Collaborator: Wakunaga Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: Probiotic mixture; Dietary Supplement: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: 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 Start Date: January 2015
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Serum Total Immunoglobulin E (IgE) [ Time Frame: baseline and week 6 ]
   Serum total immunoglobulin E (IgE) was quantified via ELISA
2. 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.
3. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Florida

University of Florida

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

Wakunaga Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Bobbi Langkamp-Henken, PhD, RD; University of Florida

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT02349711
• Other Study ID Numbers: IRB201400894; Project No. 00120905 ( Other Identifier: Wakunaga Pharmaceutical Co., Ltd. )
• First Posted: January 29, 2015
• Results First Posted: August 31, 2016
• Last Update Posted: June 9, 2017
• Last Verified: May 2017

Keywords provided by University of Florida:

probiotic; allergy; immune

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate