Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.

October 15, 2024 updated by: Kerry Group P.L.C

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stool frequency
Time Frame: 6 weeks period, from enrollment to the end of the study.
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.
Time Frame: 6 weeks period, from enrollment to the end of the study.
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
Time Frame: 6 weeks period, from enrollment to the end of the study.
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
Time Frame: 6 weeks period, from enrollment to the end of the study.
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
Time Frame: 4 weeks period, assessment at Day 0, Day 14 and Day28
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
Time Frame: 6 weeks; assessment at Day 0, Day 14 and Day 28
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
Time Frame: 6 weeks; assessment at Day 0, Day 14 and Day 28
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of the impact of the intervention on the quality of life
Time Frame: 6 weeks; assessment at Day 0, Day 14 and Day 28.
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
Time Frame: from Day 0 to Day 28
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)
Time Frame: Day 0 and Day 28
To assess changes in the Aspartate Aminotransferase blood levels (U/L).
Day 0 and Day 28
Safety assessment- Liver profile-alanine aminotransferase (ALT)
Time Frame: Day 0 and Day 28
To assess changes in Alanine Aminotransferase (ALT) blood levels (U/L).
Day 0 and Day 28
Safety assessment- Liver profile- Bilirubin
Time Frame: Day 0 and Day 28
To assess changes in blood bilirubin levels (µmol/L).
Day 0 and Day 28
Safety assessment- Heart rate (vitals)
Time Frame: Day 0, Day 14 and Day 28
Heart rate (beats per minute)
Day 0, Day 14 and Day 28
Safety assessment- Blood pressure (vitals)
Time Frame: Day 0, Day 14 and Day 28
blood pressure, both of systolic and diastolic (mm Hg)
Day 0, Day 14 and Day 28
Safety assessment-ECG findings
Time Frame: Day 0
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
Time Frame: Day 0 and Day 28
To determine any changes in the routine urine analysis test.
Day 0 and Day 28
Safety assessment-stool analysis
Time Frame: Day 0 and Day 28
To determine any changes in the routine stool analysis test.
Day 0 and Day 28
Safety assessment- Chest X-ray findings
Time Frame: Day 0
Standard Chest X-ray to be checked before the start of the study.
Day 0
Safety assessment- Kidney profile-Urea
Time Frame: Day 0 and Day 28
To assess changes in blood urea levels (mmol/L).
Day 0 and Day 28
Safety assessment- Kidney profile-Creatinine
Time Frame: Day 0 and Day 28
To assess changes in blood creatinine levels (µmol/L)
Day 0 and Day 28
Safety assessment- Lipid Profile
Time Frame: Day 0 and Day 28
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
Time Frame: Day 0 and Day 28
To assess changes in blood glucose levels (mmol/L)
Day 0 and Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kerry Group P.L.C

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gang Hu, MD, Beijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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