Effect of Bacillus Coagulans in Adults With With Functional Constipation

Not Applicable

Completed

• Conditions: Constipation - Functional
• Interventions: Dietary Supplement: Control group; Dietary Supplement: Bacillus coagulans group

• 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.

Study Timeline

• Study Start: 2021-07-20
• Study First Submitted: 2021-07-30
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-09
• Primary Completion: 2022-02-27
• Study Completion: 2022-04-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• function constipation by Romes criteria IV

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
Control group	Control group	This group takes placebo for 12 weeks.
Bacillus coagulans group	Bacillus coagulans group	This group takes Bacillus coagulans for 12 weeks.

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.
fecal microbial diversity	8 weeks	using gut microbiome analysis
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.

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of