Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.

NCT06644001 | Completed

• 1 other identifier: S23-1464685
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Digestive Discomfort; Constipation; Microbiota

Keywords

GI microbiota, bowel habits, GI symptoms

Outcome Measures

Primary Outcomes (7)

• Stool frequency

  Changes in stool frequency, defined as the number of stools per day. Participants will record their daily stool frequency in a Health Daily Diary. Comparisons will be made between the intervention group and the control group and between timepoints, specifically at each week during the 2-week run-in period and each week from Week 1 to Week 4.

  6 weeks period, from enrollment to the end of the study.

• Stool consistency.

  Changes in stool consistency will be assessed using the standard Bristol Stool Scale (BSS). Participants will record their daily stool consistency in a Health Daily Diary. Comparisons will be made between the intervention group and the control group and between timepoints. Specifically, at each week during the 2-week run-in period and each week from Week 1 to Week 4.

  6 weeks period, from enrollment to the end of the study.

• Improvement of constipation rate

  Constipation is defined as present if a participant has \<4 stools/week and absent if 4 stools/week or more were noted. Analysis will be conducted using data on stool frequency collected by the participants in the Health Daily Diary. Comparisons will be made between groups and between timepoints. Specifically at each week during the 2-week run-in period and each week from Week 1 to Week 4.

  6 weeks period, from enrollment to the end of the study.

• Improvement in the defection effort

  Data on symptoms during defection will be collected from the Health Daily Diary and scored as: 0=normal stool habit, 1=defection with mild discomfort, 2= defection with discomfort and difficulty, or 3=defection with frequent abdominal pain or burning. Comparisons will be made between the intervention group and control group and between timepoints. Specifically, at each week during the 2-week run-in period and each week from Week 1 to Week 4.

  6 weeks period, from enrollment to the end of the study.

• Changes in intestinal microbiota

  Assessment of changes in the diversity of the fecal microbiota and relative abundance after intervention. Comparisons will be made between groups and between timepoints. Specifically at specifically at baseline (Day 0), Day 14, and Week 28 (end of the study).

  4 weeks period, assessment at Day 0, Day 14 and Day28

• Improvement in digestive symptoms scores

  Assessed by the Gastrointestinal Symptom Rates Scale (GSRS).The GSRS has 15 items rated on a seven-point Likert scale from no discomfort to very severe discomfort. These items are grouped into five domains: abdominal pain, reflux, diarrhea, indigestion, and constipation. Scores are the mean of items within each domain, with higher scores indicating more severe symptoms. The overall GSRS score is the average of the five domain scores. Comparisons will be made between the intervention and control groups and at days 0, 14, and 28.

  6 weeks; assessment at Day 0, Day 14 and Day 28

• Improvement in upper GI symptoms

  The Severity Of Dyspepsia Assessment (SODA) tool evaluates four symptoms: dyspepsia, heartburn, reflux, and nausea. Each symptom is rated by frequency: 1 (none per week), 2 (once per week), 3 (1-2 times per week), 4 (3-4 times per week), and 5 (daily or more). A decrease in the score over time indicates an improvement in symptoms. Comparisons will be made between the intervention and control groups and at days 0, 14, and 28.

  6 weeks; assessment at Day 0, Day 14 and Day 28

Secondary Outcomes (15)

• Assessment of the impact of the intervention on the quality of life

  6 weeks; assessment at Day 0, Day 14 and Day 28.

• Safety assessment-Safety as measured by adverse events

  from Day 0 to Day 28

• Safety assessment -liver function- Aspartate Aminotransferase (AST)

  Day 0 and Day 28

• Safety assessment- Liver profile-alanine aminotransferase (ALT)

  Day 0 and Day 28

• Safety assessment- Liver profile- Bilirubin

  Day 0 and Day 28

Study Arms (2)

Probiotic

EXPERIMENTAL

Bacillus coagulans

Dietary Supplement: Bacillus coagulans GBI-30,6086 (BC GBI-30)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

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

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

Probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults male or female aged 18-65 years old. 2- Generally healthy but with irregular bowel movements, including \&lt;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.
• Subjects enrolled in the study voluntarily and signed the Consent Form.

You may not qualify if:

• Subjects aged \&lt;18 or \&gt; 65 years, pregnant or lactating women, and those who are susceptible to allergens or have food allergies.
• Subjects with cardiovascular, cerebrovascular, hepatic, renal, hematopoietic diseases or endocrine diseases, and or mental illness.
• 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.)
• Subjects who could not eat orally or take the study products as prescribed or cannot comply with the protocol.
• Subjects administered relevant products recently, which would affect the outcome of the study.
• 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.
• Subjects who suffered from gastrointestinal disease within the past month.
• Subjects who had taken antibiotics in the past month.
• Subjects who had not taken the test product as prescribed or took other supplements or drugs.
• Subjects with incomplete data or incomplete information, so that the efficacy could not be estimated.

Sponsors & Collaborators

• Kerry Group P.L.C: lead
• Beijing Hospital: collaborator

Study Sites (1)

Beijing Hospital

Beijing, China

Location

Related Publications (1)

• Gang H, Wei J, McFarland LV, Zahra R, Saez ME, Blanco-Rojo R, Millette M. Impact of Heyndrickxia (Bacillus) coagulans GBI-30, 6086 (BC30) probiotic on gastrointestinal function in healthy adults: a randomised controlled trial. Benef Microbes. 2025 Jul 22:1-18. doi: 10.1163/18762891-bja00084. Online ahead of print.

  PMID: 40707016 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gang Hu, MD

  Beijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 16, 2024
• Study Start: July 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)