Probiotics on Stress-associated Gastrointestinal Function in University Students

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Bifidobacterium longum; Dietary Supplement: Bifidobacterium bifidum; Dietary Supplement: Probiotic Combination

• Registration Number: NCT03056846
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2017-02-14
• Study First Posted: 2017-02-17
• Study Start: 2017-09-05
• Primary Completion: 2017-12-21
• Study Completion: 2018-02-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Bifidobacterium longum	Bifidobacterium longum	A commercially available probiotic strain (Bifidobacterium longum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Bifidobacterium bifidum	Bifidobacterium bifidum	A commercially available probiotic strain (Bifidobacterium bifidum) will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Probiotic Combination	Probiotic Combination	A commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).

Primary Outcome Measures

Name	Time	Method
Change in Gastrointestinal Symptom Response Scale (GSRS) constipation symptom score	Baseline (Week 0) to Final (Week 6)	Weekly GSRS constipation symptom score in probiotic mixture vs. individual probiotic vs. placebo

Secondary Outcome Measures

Name	Time	Method
Microbiota studies, measured by 16S rRNA sequence analysis	Baseline (Week 0) and Week 5	Microbial diversity measured by 16S rRNA sequence analysis
Immune health, measured by questionnaire data	Baseline (Week 0) to Final (Week 6)	Proportion of healthy days (i.e., days without cold symptoms with an intensity \>6). Daily health questionnaires ask students about non-allergy-related cold symptoms (running/congested nose, stiffness or chills, headache, cough, fatigue, fever, sore throat, achiness, and ear discomfort) and symptom intensity (0=none, 1=mild, 2=moderate, 3=severe)
Change in reflux symptoms, measured by GSRS	Baseline (Week 0) to Final (Week 6)	Weekly GSRS reflux symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Change in indigestion symptoms, measured by GSRS	Baseline (Week 0) to Final (Week 6)	Weekly GSRS indigestion symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Weekly average of daily levels of stress	Baseline (Week 0) to Final (Week 6)	Daily stress (0 = no stress to 10 = severe or extreme stress)
Change in diarrhea symptoms, measured by GSRS	Baseline (Week 0) to Final (Week 6)	Weekly GSRS diarrhea symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Change in abdominal pain symptoms, measured by GSRS	Baseline (Week 0) to Final (Week 6)	Weekly GSRS abdominal pain symptom scores in probiotic mixture vs. individual probiotic vs. placebo
Microbiota studies, qPCR	Baseline (Week 0) and Week 5	qPCR to quantify changes in bacteria of interest
Immune function, measured by questionnaire data	Baseline (Week 0) to Final (Week 6)	Symptom intensity score (average sum of symptom intensities)

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States