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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
111
2g powder/sachet, consists of bacillus coagulans at a dose of 1x10\^9 CFU, taken once daily before a meal.
2g powder/sachet, consists of maltodextrin only, taken once daily before a meal.
Beijing Hospital
Beijing, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks period, from enrollment to the end of the study.
Changes in intestinal microbiota
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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).
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks; assessment at Day 0, Day 14 and Day 28
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.
Time frame: 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.
Time frame: from Day 0 to Day 28
Safety assessment -liver function- Aspartate Aminotransferase (AST)
To assess changes in the Aspartate Aminotransferase blood levels (U/L).
Time frame: Day 0 and Day 28
Safety assessment- Liver profile-alanine aminotransferase (ALT)
To assess changes in Alanine Aminotransferase (ALT) blood levels (U/L).
Time frame: Day 0 and Day 28
Safety assessment- Liver profile- Bilirubin
To assess changes in blood bilirubin levels (µmol/L).
Time frame: Day 0 and Day 28
Safety assessment- Heart rate (vitals)
Heart rate (beats per minute)
Time frame: Day 0, Day 14 and Day 28
Safety assessment- Blood pressure (vitals)
blood pressure, both of systolic and diastolic (mm Hg)
Time frame: 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.
Time frame: Day 0
Safety assessment-urine analysis
To determine any changes in the routine urine analysis test.
Time frame: Day 0 and Day 28
Safety assessment-stool analysis
To determine any changes in the routine stool analysis test.
Time frame: Day 0 and Day 28
Safety assessment- Chest X-ray findings
Standard Chest X-ray to be checked before the start of the study.
Time frame: Day 0
Safety assessment- Kidney profile-Urea
To assess changes in blood urea levels (mmol/L).
Time frame: Day 0 and Day 28
Safety assessment- Kidney profile-Creatinine
To assess changes in blood creatinine levels (µmol/L)
Time frame: 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).
Time frame: Day 0 and Day 28
Safety assessment- Blood Glucose levels
To assess changes in blood glucose levels (mmol/L)
Time frame: Day 0 and Day 28