Occasional Constipation Clinical Trial
Official title:
The Effect of Bacillus Subtilis DE111® on the Daily Bowel Movement Profile for People With Occasional Gastrointestinal Irregularity
The purpose of this study is to determine the efficacy of Bacillus subtilis DE111® probiotic for regulation of bowel movements.
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. ;
| 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 |