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Probiotics on Stress-associated Gastrointestinal Function in University Students

NCT03056846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2019-03-25

No results posted yet for this study

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.

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • Wakunaga Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Bobbi Langkamp-Henken, PhD, RD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2017-12-21
Completion
2018-02-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056846 on ClinicalTrials.gov