Probiotics on Stress-associated Gastrointestinal Function in University Students

NCT03056846 | Completed

• 1 other identifier: IRB201600917
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

probiotic; gastrointestinal; stress; student

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in diarrhea symptoms, measured by GSRS

  Baseline (Week 0) to Final (Week 6)

• Change in abdominal pain symptoms, measured by GSRS

  Baseline (Week 0) to Final (Week 6)

• Change in indigestion symptoms, measured by GSRS

  Baseline (Week 0) to Final (Week 6)

• Change in reflux symptoms, measured by GSRS

  Baseline (Week 0) to Final (Week 6)

• Weekly average of daily levels of stress

  Baseline (Week 0) to Final (Week 6)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Probiotic Combination

EXPERIMENTAL

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

Bifidobacterium bifidum

EXPERIMENTAL

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

Bifidobacterium longum

EXPERIMENTAL

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

Interventions

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).

Placebo

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).

Also known as: Kyo-Dophilus, Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, Bifidobacterium longum MM-2

Probiotic Combination

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).

Also known as: Kyo-Dophilus, Bifidobacterium bifidum G9-1

Bifidobacterium bifidum

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.

Also known as: Kyo-Dophilus, Bifidobacterium longum MM-2

Bifidobacterium longum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Wakunaga Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Study Officials

• Bobbi Langkamp-Henken, PhD, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: February 17, 2017
• Study Start: September 5, 2017
• Primary Completion: December 21, 2017
• Study Completion: February 5, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

US (1)