Probiotics on Stress-associated Gastrointestinal Function in University Students

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 21, 2017

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.

Interventions

  • Dietary Supplement: 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).
  • Dietary Supplement: Probiotic Combination
    • A 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 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
  • Dietary Supplement: Bifidobacterium bifidum
    • A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
  • Dietary Supplement: Bifidobacterium longum
    • A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.

Arms, Groups and Cohorts

  • Placebo Comparator: 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).
  • Experimental: 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).
  • Experimental: 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).
  • Experimental: 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).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in diarrhea symptoms, measured by GSRS
    • Time Frame: 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
    • Time Frame: Baseline (Week 0) to Final (Week 6)
    • Weekly GSRS abdominal pain symptom scores in probiotic mixture vs. individual probiotic vs. placebo
  • Change in indigestion symptoms, measured by GSRS
    • Time Frame: Baseline (Week 0) to Final (Week 6)
    • Weekly GSRS indigestion symptom scores in probiotic mixture vs. individual probiotic vs. placebo
  • Change in reflux symptoms, measured by GSRS
    • Time Frame: Baseline (Week 0) to Final (Week 6)
    • Weekly GSRS reflux symptom scores in probiotic mixture vs. individual probiotic vs. placebo
  • Weekly average of daily levels of stress
    • Time Frame: Baseline (Week 0) to Final (Week 6)
    • Daily stress (0 = no stress to 10 = severe or extreme stress)
  • Microbiota studies, measured by 16S rRNA sequence analysis
    • Time Frame: Baseline (Week 0) and Week 5
    • Microbial diversity measured by 16S rRNA sequence analysis
  • Microbiota studies, qPCR
    • Time Frame: Baseline (Week 0) and Week 5
    • qPCR to quantify changes in bacteria of interest
  • Immune health, measured by questionnaire data
    • Time Frame: 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)
  • Immune function, measured by questionnaire data
    • Time Frame: Baseline (Week 0) to Final (Week 6)
    • Symptom intensity score (average sum of symptom intensities)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • Wakunaga Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bobbi Langkamp-Henken, PhD, RD, Principal Investigator, University of Florida

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