Occasional Constipation Clinical Trial
Official title:
The Effect of Bacillus Subtilis DE111® on the Daily Bowel Movement Profile for People With Occasional Gastrointestinal Irregularity
Verified date | September 2019 |
Source | Deerland Enzymes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic for regulation of bowel movements.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Kennesaw State University | Kennesaw | Georgia |
Lead Sponsor | Collaborator |
---|---|
Deerland Enzymes | Kennesaw State University |
United States,
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06444139 -
Probiotic Intervention for Occasional Constipation
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N/A | |
Completed |
NCT02423564 -
A Study Investigating the Effect of Digesta-Lac in Healthy Adults With Occasional Constipation
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Phase 2 |