Clinical trial NCT06644001: Bacillus Coagulans Effect on Gastrointestinal Function in Healthy Adults.
Official title: Impact of Heyndrickxia (Bacillus) Coagulans Probiotic on Gastrointestinal Function in Healthy Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive Discomfort
Constipation
Microbiota
Keywords: GI microbiota, bowel habits, GI symptoms
Lead sponsor: Kerry Group P.L.C
Sponsor class: INDUSTRY
Collaborators: name: Beijing Hospital
First posted: 2024-10-16
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1- 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.

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

Exclusion Criteria:

1. Subjects aged \&lt;18 or \&gt; 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.

Primary outcomes:
measure: Stool frequency
timeFrame: 6 weeks period, from enrollment to the end of the study.
measure: Stool consistency.
timeFrame: 6 weeks period, from enrollment to the end of the study.
measure: Improvement of constipation rate
timeFrame: 6 weeks period, from enrollment to the end of the study.
measure: Improvement in the defection effort
timeFrame: 6 weeks period, from enrollment to the end of the study.
measure: Changes in intestinal microbiota
timeFrame: 4 weeks period, assessment at Day 0, Day 14 and Day28
measure: Improvement in digestive symptoms scores
timeFrame: 6 weeks; assessment at Day 0, Day 14 and Day 28
measure: Improvement in upper GI symptoms
timeFrame: 6 weeks; assessment at Day 0, Day 14 and Day 28
Secondary outcomes:
measure: Assessment of the impact of the intervention on the quality of life
timeFrame: 6 weeks; assessment at Day 0, Day 14 and Day 28.
measure: Safety assessment-Safety as measured by adverse events
timeFrame: from Day 0 to Day 28
measure: Safety assessment -liver function- Aspartate Aminotransferase (AST)
timeFrame: Day 0 and Day 28
measure: Safety assessment- Liver profile-alanine aminotransferase (ALT)
timeFrame: Day 0 and Day 28
measure: Safety assessment- Liver profile- Bilirubin
timeFrame: Day 0 and Day 28
measure: Safety assessment- Heart rate (vitals)
timeFrame: Day 0, Day 14 and Day 28
measure: Safety assessment- Blood pressure (vitals)
timeFrame: Day 0, Day 14 and Day 28
measure: Safety assessment-ECG findings
timeFrame: Day 0
measure: Safety assessment-urine analysis
timeFrame: Day 0 and Day 28
measure: Safety assessment-stool analysis
timeFrame: Day 0 and Day 28
measure: Safety assessment- Chest X-ray findings
timeFrame: Day 0
measure: Safety assessment- Kidney profile-Urea
timeFrame: Day 0 and Day 28
measure: Safety assessment- Kidney profile-Creatinine
timeFrame: Day 0 and Day 28
measure: Safety assessment- Lipid Profile
timeFrame: Day 0 and Day 28
measure: Safety assessment- Blood Glucose levels
timeFrame: Day 0 and Day 28
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
Study officials:
affiliation: Beijing Hospital
name: Gang Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: