Probiotics on Stress-associated Gastrointestinal Function in University Students

Healthy Clinical Trial

— SAS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056846
• Other study ID #: IRB201600917
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: February 5, 2018

Study information

• Verified date: March 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: February 5, 2018
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Wakunaga Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Microbiota studies, measured by 16S rRNA sequence analysis	Microbial diversity measured by 16S rRNA sequence analysis	Baseline (Week 0) and Week 5
Secondary	Microbiota studies, qPCR	qPCR to quantify changes in bacteria of interest	Baseline (Week 0) and Week 5
Secondary	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)
Secondary	Immune function, measured by questionnaire data	Symptom intensity score (average sum of symptom intensities)	Baseline (Week 0) to Final (Week 6)