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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04083521
Other study ID # DE111Reg
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date August 31, 2017

Study information

Verified date September 2019
Source Deerland Enzymes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Kennesaw State University Kennesaw Georgia

Sponsors (2)

Lead Sponsor Collaborator
Deerland Enzymes Kennesaw State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bowel movement regularity Increasing regularity of bowel movements in subjects with occasional diarrhea or constipation 105-day study period (consisting of 90-days treatment plus 15-day follow up)
Primary Tolerance To determine if the supplement is tolerable among subjects without causing adverse events 105-day study period (consisting of 90-days treatment plus 15-day follow up)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06444139 - Probiotic Intervention for Occasional Constipation N/A
Completed NCT02423564 - A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation Phase 2