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Completed

NCT Number: NCT04083521

Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

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

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Key information

Conditions

Bowel Movement Regulation Occasional Constipation Occasional Diarrhea

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennesaw State University

Kennesaw, Georgia, 30144, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bacillus subtilis DE111®

Dietary Supplement

Subjects were administered a dose of Bacillus subtilis at levels of 1x10^9 CFU once a day for 90-days.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Deerland Enzymes

Industry

Collaborators

  • Kennesaw State University

Registry information

Official study title

The Effect of Bacillus Subtilis DE111® on the Daily Bowel Movement Profile for People With Occasional Gastrointestinal Irregularity

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2019
Registry last updated
Sep 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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