Clinical trial NCT02349711: Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: probiotic
allergy
immune
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Wakunaga Pharmaceutical Co., Ltd.
First posted: 2015-01-29
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: up to 8 weeks from date of randomization
Secondary outcomes:
measure: Serum Total Immunoglobulin E (IgE)
timeFrame: baseline and week 6
measure: Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire
timeFrame: weeks 0, 1, 2, 3, 4, 5, 6, 7
measure: Regulatory T Cells (Tregs)
timeFrame: baseline and week 6
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.