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Completed

NCT Number: NCT03056846

Probiotics on Stress-associated Gastrointestinal Function in University Students

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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).

Probiotic Combination

Dietary Supplement

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

Bifidobacterium bifidum

Dietary Supplement

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

Bifidobacterium longum

Dietary Supplement

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. Microbiota studies, measured by 16S rRNA sequence analysis

    Time frame: Baseline (Week 0) and Week 5

    Microbial diversity measured by 16S rRNA sequence analysis

  7. Microbiota studies, qPCR

    Time frame: Baseline (Week 0) and Week 5

    qPCR to quantify changes in bacteria of interest

  8. 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)

  9. Immune function, measured by questionnaire data

    Time frame: Baseline (Week 0) to Final (Week 6)

    Symptom intensity score (average sum of symptom intensities)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Wakunaga Pharmaceutical Co., Ltd.

Registry information

Official study 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

Acronym: SAS

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 17, 2017
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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