NCT04083521

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

September 6, 2019

Last Update Submit

September 6, 2019

Conditions

Bowel Movement RegulationOccasional ConstipationOccasional Diarrhea

Keywords

Bowel movement regulationOccasional constipationOccasional diarrheaGastrointestinal health

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

Treatment

EXPERIMENTAL

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

Dietary Supplement: Bacillus subtilis DE111®

Placebo

NO INTERVENTION

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

Interventions

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.

Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants suffering from occasional constipation and/or diarrhea will be eligible for participation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennesaw State University

Kennesaw, Georgia, 30144, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

September 1, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)