Effect of Bacillus Coagulans in Adults With With Functional Constipation
- Conditions
- Constipation - Functional
- Registration Number
- NCT04997187
- Lead Sponsor
- Pusan National University Yangsan Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- function constipation by Romes criteria IV
- Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
- Uncontrolled diabetes mellitus (>160 mg/dL of fasting blood sugar)
- Uncontrolled hypertension (>160/100 mmHg)
- Uncontrolled thyroid diseases.
- History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
- History of structural abnormalities of colon within 4 year
- History of medication for probiotics and psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
- Alcohol abuser
- Allergic reaction to this test food
- Those who participated in other drug clinical trials within 1 month from the screening date.
- Severe gastrointestinal symptoms such as heartburn and indigestion
- Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
- Those who are judged to be unsuitable by the PI for other reasons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method constipation visual analogue scale 8 weeks 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.
- Secondary Outcome Measures
Name Time Method visual analogue scale for irritable bowel syndrome 8 weeks 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.
irritable bowel syndrome-symptom severity scale 8 weeks 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.
irritable bowel syndrome-quality-of-life 8 weeks using IBS-QOL questionnaire. The minimum value was 0 score and the maximum value was 5 score and higher scores mean a better outcome.
Bristol Stool Form Scale (BSFS) type 3 & 4 ratio (%) 8 weeks using Bristol Stool Form Scale. The minimum value was 0% and the maximum value was 100%, and higher scores mean a better outcome.
fecal microbial diversity 8 weeks using gut microbiome analysis
Trial Locations
- Locations (1)
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeungsangnam-do, Korea, Republic of
Pusan National University Yangsan Hospital🇰🇷Yangsan, Gyeungsangnam-do, Korea, Republic of