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Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

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: NCT04083521
Recruitment Status : Completed
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Kennesaw State University
Information provided by (Responsible Party):
Deerland Enzymes

Brief Summary:
The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic for regulation of bowel movements.

Condition or disease Intervention/treatment Phase
Bowel Movement Regulation Occasional Constipation Occasional Diarrhea Dietary Supplement: Bacillus subtilis DE111® Not Applicable

Detailed Description:
The purpose of this study is to determine the efficacy of the probiotic B. subtilis DE111® for regulation of bowel movements. A single capsule containing 1 x 10^9 CFU B. subtilis is to be consumed once a day per participant. 50 adults (18-65 years of age at the time of participation) suffering from occasional constipation and/or diarrhea will be enrolled. Participants will be double-blindly and randomly assigned to either the probiotic (Bacillus subtilis) or the placebo (maltodextrin) group. Efficacy will be assessed with participant-reported bowel movement (BM) records. As a secondary outcome, the study will provide further insight into the tolerance of the supplement. Tolerance will be assessed using a digestive health questionnaire and blood samples to analyze pertinent metabolic biomarkers. Participants will be asked to complete a daily dietary intake record as well. Prior to capsule consumption, participants will complete a two-week pre-testing phase in order to provide a more inclusive diagnostic baseline. This phase will consist of daily BM and dietary intake record keeping.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Bacillus Subtilis DE111® on the Daily Bowel Movement Profile for People With Occasional Gastrointestinal Irregularity
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Treatment
Subjects received a once daily dose of Bacillus subtilis DE111® 1x10^9 CFU for 90-days.
Dietary Supplement: Bacillus subtilis DE111®
Subjects were administered a dose of Bacillus subtilis at levels of 1x10^9 CFU once a day for 90-days.

No Intervention: Placebo
Subjects received a once daily dose of maltodextrin for 90-days.



Primary Outcome Measures :
  1. Bowel movement regularity [ Time Frame: 105-day study period (consisting of 90-days treatment plus 15-day follow up) ]
    Increasing regularity of bowel movements in subjects with occasional diarrhea or constipation

  2. Tolerance [ Time Frame: 105-day study period (consisting of 90-days treatment plus 15-day follow up) ]
    To determine if the supplement is tolerable among subjects without causing adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants suffering from occasional constipation and/or diarrhea will be eligible for participation.

Exclusion Criteria:

  • Blood CRP levels for each participant will be monitored at days 0, 60 and 105 of this study. Participants with CRP levels greater than 5mg/l on day 0 of the study will be excluded from further participation as this level is indicative of underlying inflammatory bowel disease. Participants excluded under such conditions will be instructed to seek further treatment with their health care provider.

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): NCT04083521


Locations
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United States, Georgia
Kennesaw State University
Kennesaw, Georgia, United States, 30144
Sponsors and Collaborators
Deerland Enzymes
Kennesaw State University
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Responsible Party: Deerland Enzymes
ClinicalTrials.gov Identifier: NCT04083521    
Other Study ID Numbers: DE111Reg
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Deerland Enzymes:
Bowel movement regulation
Occasional constipation
Occasional diarrhea
Gastrointestinal health
Additional relevant MeSH terms:
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Constipation
Diarrhea
Signs and Symptoms, Digestive