Effect of Bacillus Subtilis DE111® on Daily Bowel Movements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bowel Movement Regulation Occasional Constipation Occasional Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Subjects received a once daily dose of Bacillus subtilis DE111® 1x10\^9 CFU for 90-days.

Group Type EXPERIMENTAL

Bacillus subtilis DE111®

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Subjects received a once daily dose of maltodextrin for 90-days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bacillus subtilis DE111®

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes