Effect of Bacillus Coagulans in Adults With With Functional Constipation

Constipation - Functional Clinical Trial

Official title:

Effect of Bacillus Coagulans on Various Symptoms and Fecal Microbial Diversity in Adults With With Functional Constipation: a Randomized, Double-blinded, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04997187
• Other study ID #: 02-2021-008
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: April 2023
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 15, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Dietary Supplement:
• Bacillus coagulans group
Bacillus coagulans 400 mg/day for 12 weeks
• Control group
Placebo 400 mg/day for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	Bristol Stool Form Scale (BSFS) type 3 & 4 ratio (%)	using Bristol Stool Form Scale. The minimum value was 0% and the maximum value was 100%, and higher scores mean a better outcome.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	fecal microbial diversity	using gut microbiome analysis	8 weeks