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

University of Florida

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Bifidobacterium bifidum; Dietary Supplement: Placebo; Dietary Supplement: Probiotic Combination; Dietary Supplement: Bifidobacterium longum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03056846

IRB201600917

Details and patient eligibility

About

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 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.

Enrollment: 634 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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634 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Placebo

Probiotic Combination

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Probiotic Combination

Bifidobacterium bifidum

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Bifidobacterium bifidum

Bifidobacterium longum

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Bifidobacterium longum