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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056846
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Wakunaga Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Placebo Dietary Supplement: Probiotic Combination Dietary Supplement: Bifidobacterium bifidum Dietary Supplement: Bifidobacterium longum Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 634 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : February 5, 2018

Arm Intervention/treatment
Placebo Comparator: 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: 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).

Experimental: Probiotic Combination
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
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

Experimental: Bifidobacterium bifidum
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
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

Experimental: Bifidobacterium longum
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
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 Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056846


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Wakunaga Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03056846    
Other Study ID Numbers: IRB201600917
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
probiotic
gastrointestinal
stress
student
Additional relevant MeSH terms:
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Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents