Clinical trial NCT03056846: Probiotics on Stress-associated Gastrointestinal Function in University Students
Official title: Probiotics (Lactobacillus Gasseri KS-13, Bifidobacterium Bifidum G9-1, Bifidobacterium Longum MM-2) on Stress-associated Gastrointestinal Function in University Students: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: probiotic
gastrointestinal
stress
student
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Wakunaga Pharmaceutical Co., Ltd.
First posted: 2017-02-17
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research study is to evaluate the effect of a daily supplement of probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2) on stress-associated gastrointestinal function in university students during the time of semester exams.

Detailed description: In this randomized, double-blind, placebo-controlled study, undergraduate students planning to take a fall final exam will receive a daily probiotic combination, individual probiotic, or placebo for 6 weeks. Questionnaires will assess gastrointestinal symptoms, immune health, stress and stress management, quality of life, diet, adverse events, and compliance. In a subset of subjects, stool samples will be collected at baseline and at week 5 of the intervention (the week before final exams) to characterize microbial communities.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Healthy full-time undergraduate student at the University of Florida
* Willing and able to consume a daily supplement (probiotic or placebo) for the duration of the 6-week study
* Willing and able to complete daily questionnaires online regarding general health and well-being, including stress levels and gastrointestinal symptoms (Note: we will recruit participants who will have Internet access for the duration of the protocol, but understand that, once enrolled, situations may change. If this is the case, paper copies of the online forms will be provided)
* Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, Echinacea, fish oil, vitamin E \[\>400% of the RDA or \>60 mg/day\])
* Had a cold/flu within the past year

Exclusion Criteria:

* Currently smoke
* Women who are lactating, know that they are pregnant, or are attempting to get pregnant
* Currently taking any systemic corticosteroids
* Currently being treated for any physician-diagnosed diseases
* Have received chemotherapy or other immune suppressing therapy within the last year

Primary outcomes:
measure: Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score
timeFrame: Baseline (Week 0) to Final (Week 6)
Secondary outcomes:
measure: Change in diarrhea symptoms, measured by GSRS
timeFrame: Baseline (Week 0) to Final (Week 6)
measure: Change in abdominal pain symptoms, measured by GSRS
timeFrame: Baseline (Week 0) to Final (Week 6)
measure: Change in indigestion symptoms, measured by GSRS
timeFrame: Baseline (Week 0) to Final (Week 6)
measure: Change in reflux symptoms, measured by GSRS
timeFrame: Baseline (Week 0) to Final (Week 6)
measure: Weekly average of daily levels of stress
timeFrame: Baseline (Week 0) to Final (Week 6)
measure: Microbiota studies, measured by 16S rRNA sequence analysis
timeFrame: Baseline (Week 0) and Week 5
measure: Microbiota studies, qPCR
timeFrame: Baseline (Week 0) and Week 5
measure: Immune health, measured by questionnaire data
timeFrame: Baseline (Week 0) to Final (Week 6)
measure: Immune function, measured by questionnaire data
timeFrame: Baseline (Week 0) to Final (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: