Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.

Impact of Heyndrickxia (Bacillus) Coagulans Probiotic on Gastrointestinal Function in Healthy Adults: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Microbiota; Digestive Discomfort
• Intervention / Treatment: Dietary supplement: Bacillus coagulans GBI-30,6086 (BC GBI-30); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 2g powder/sachet, consists of maltodextrin only, taken once daily before a meal.
Experimental: Probiotic; Bacillus coagulans	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the impact of the intervention on the quality of life	Changes in Quality of Life (QoL) will be assessed using the 36-Item Short Form Survey (SF-36) version 2. The questionnaire evaluates eight domains of a person's health-related quality of life. Scores for the different domains are converted to a 0-100 scale, where a lower score indicates worse QoL and a higher score reflects better outcome.	6 weeks; assessment at Day 0, Day 14 and Day 28.
Safety assessment-Safety as measured by adverse events	Documentation of any adverse events to the study product by participants in their daily health diary.	from Day 0 to Day 28
Safety assessment -liver function- Aspartate Aminotransferase (AST)	To assess changes in the Aspartate Aminotransferase blood levels (U/L).	Day 0 and Day 28
Safety assessment- Liver profile-alanine aminotransferase (ALT)	To assess changes in Alanine Aminotransferase (ALT) blood levels (U/L).	Day 0 and Day 28
Safety assessment- Liver profile- Bilirubin	To assess changes in blood bilirubin levels (µmol/L).	Day 0 and Day 28
Safety assessment- Heart rate (vitals)	Heart rate (beats per minute)	Day 0, Day 14 and Day 28
Safety assessment- Blood pressure (vitals)	blood pressure, both of systolic and diastolic (mm Hg)	Day 0, Day 14 and Day 28
Safety assessment-ECG findings	Including heart rate (beats per minute), PR Interval (milliseconds), PQ Interval (milliseconds), RR Interval (milliseconds), QRS Interval (milliseconds), and QT Interval (milliseconds), will be recorded.	Day 0
Safety assessment-urine analysis	To determine any changes in the routine urine analysis test.	Day 0 and Day 28
Safety assessment-stool analysis	To determine any changes in the routine stool analysis test.	Day 0 and Day 28
Safety assessment- Chest X-ray findings	Standard Chest X-ray to be checked before the start of the study.	Day 0
Safety assessment- Kidney profile-Urea	To assess changes in blood urea levels (mmol/L).	Day 0 and Day 28
Safety assessment- Kidney profile-Creatinine	To assess changes in blood creatinine levels (µmol/L)	Day 0 and Day 28
Safety assessment- Lipid Profile	To assess changes in blood lipid profile including : Cholesterol (mmol/L), Triglyceride (mmol/L), HDL (mmol/L) and LDL (mmol/L).	Day 0 and Day 28
Safety assessment- Blood Glucose levels	To assess changes in blood glucose levels (mmol/L)	Day 0 and Day 28

Collaborators and Investigators

• Sponsor: Kerry Group P.L.C
• Collaborators: Beijing Hospital
• Investigators: Principal Investigator: Gang Hu, MD, Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: GI microbiota, bowel habits, GI symptoms
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: S23-1464685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No