Probiotics on Stress-associated Gastrointestinal Function in University Students (SAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic Combination; Dietary supplement: Bifidobacterium bifidum; Dietary supplement: Bifidobacterium longum

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 Type: Interventional
• Enrollment (Actual): 634
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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).
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).	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).; Other Names: Kyo-Dophilus; Lactobacillus gasseri KS-13; Bifidobacterium bifidum G9-1; Bifidobacterium longum MM-2
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).	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).; Other Names: Kyo-Dophilus; Bifidobacterium bifidum G9-1
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).	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.; Other Names: Kyo-Dophilus; Bifidobacterium longum MM-2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Wakunaga Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): December 21, 2017
• Study Completion (Actual): February 5, 2018

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: probiotic; stress; gastrointestinal; student
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anti-Infective Agents, Urinary; Renal Agents; Sulfalene
• Other Study ID Numbers: IRB201600917

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No