The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans on various symptoms and fecal microbial diversity in adults with with functional constipation for 12 weeks.
A previous study has indicated that Bacillus coagulans provided control of abdominal pain, less discomfort during defecation, and a more normalized defecation style, especially in adults with with functional constipation. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Bacillus coagulans various symptoms and fecal microbial diversity in adults with with functional constipation for 8 weeks; the safety of the compound are also evaluated. The Investigators examine constipation visual analogue scale, Bristol Stool Form Scale type 3 \& 4 ratio, visual analogue scale for irritable bowel syndrome (VAS-IBS) questionnaire score, IBS-symptom severity scale, IBS quality-of-life questionnaire score, fecal microbial diversity at baseline, as well as after 8 weeks of intervention. Eighty adults were administered either 400 mg of Bacillus coagulans or a placebo each day for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
Bacillus coagulans 400 mg/day for 12 weeks
Placebo 400 mg/day for 12 weeks
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea
constipation visual analogue scale
using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a worse outcome.
Time frame: 8 weeks
Bristol Stool Form Scale (BSFS) type 1 & 2 ratio (%)
using Bristol Stool Form Scale. The minimum value was 0% and the maximum value was 100%, and higher scores mean a better outcome.
Time frame: 8 weeks
visual analogue scale for irritable bowel syndrome
using visual analogue scale (100 mm). The minimum value was 0 mm and the maximum value was 100 mm, and higher scores mean a better outcome.
Time frame: 8 weeks
irritable bowel syndrome-symptom severity scale
using IBS-Symptom Severity Scale questionnaire. The minimum value was 0 score and the maximum value was 500 score and higher scores mean a worse outcome.
Time frame: 8 weeks
irritable bowel syndrome-quality-of-life
using IBS-QOL questionnaire. The minimum value was 0 score and the maximum value was 5 score and higher scores mean a better outcome.
Time frame: 8 weeks
fecal microbial diversity
using gut microbiome analysis
Time frame: 8 weeks
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