Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.

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

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-10-30

Brief Summary

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A single centre, double-blind, placebo-controlled study to evaluate the effect of the consumption of Bacillus coagulans at a daily dose of 1 x 10⁹ CFU on bowel habits, intestinal microbiota and gastrointestinal symptoms in healthy adults.

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Detailed Description

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Conditions

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Digestive Discomfort Constipation Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, interventional, randomized, double-blind, parallel, placebo-controlled clinical study. Eligible subjects were randomized at a ratio of 1:1 to receive Bacillus coagulans or placebo once daily for 28 days.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Bacillus coagulans

Group Type EXPERIMENTAL

Bacillus coagulans GBI-30,6086 (BC GBI-30)

Intervention Type DIETARY_SUPPLEMENT

2g powder/sachet, consists of bacillus coagulans at a dose of 1x10\^9 CFU, taken once daily before a meal.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2g powder/sachet, consists of maltodextrin only, taken once daily before a meal.

Interventions

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Bacillus coagulans GBI-30,6086 (BC GBI-30)

2g powder/sachet, consists of bacillus coagulans at a dose of 1x10\^9 CFU, taken once daily before a meal.

Intervention Type DIETARY_SUPPLEMENT

Placebo

2g powder/sachet, consists of maltodextrin only, taken once daily before a meal.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1- Adults male or female aged 18-65 years old. 2- Generally healthy but with irregular bowel movements, including \<4 stools/week or periodic (over 2/week) loose stools 2- Agreed not to take other probiotics or prebiotics products during the study period, unless specified by the investigator.

3- Subjects enrolled in the study voluntarily and signed the Consent Form.

Exclusion Criteria

1. Subjects aged \<18 or \> 65 years, pregnant or lactating women, and those who are susceptible to allergens or have food allergies.
2. Subjects with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases or endocrine diseases, and or mental illness.
3. Subjects with constipation symptoms caused by surgical operation within the past 30 days; subjects with acute GI track diseases in the past 30 days; subjects with constipation symptoms due to severe organ lesion (colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.)
4. Subjects who could not eat orally or take the study products as prescribed or cannot comply with the protocol.
5. Subjects administered relevant products recently, which would affect the outcome of the study.
6. Subjects who took probiotics or prebiotics products (including yogurt, beverages or foods containing probiotics) within the past month, which may affect the results of the study.
7. Subjects who suffered from gastrointestinal disease within the past month.
8. Subjects who had taken antibiotics in the past month.
9. Subjects who had not taken the test product as prescribed or took other supplements or drugs.
10. Subjects with incomplete data or incomplete information, so that the efficacy could not be estimated.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes