Effect of Bacillus Coagulans in Adults With With Functional Constipation

NCT04997187 | Completed

• 1 other identifier: 02-2021-008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Bristol Stool Form Scale (BSFS) type 1 & 2 ratio (%)

  8 weeks

• visual analogue scale for irritable bowel syndrome

  8 weeks

• irritable bowel syndrome-symptom severity scale

  8 weeks

• irritable bowel syndrome-quality-of-life

  8 weeks

• fecal microbial diversity

  8 weeks

Study Arms (2)

Bacillus coagulans group

EXPERIMENTAL

This group takes Bacillus coagulans for 12 weeks.

Dietary Supplement: Bacillus coagulans group

Control group

PLACEBO COMPARATOR

This group takes placebo for 12 weeks.

Dietary Supplement: Control group

Interventions

Bacillus coagulans group DIETARY_SUPPLEMENT

Bacillus coagulans 400 mg/day for 12 weeks

Bacillus coagulans group

Control group DIETARY_SUPPLEMENT

Placebo 400 mg/day for 12 weeks

Control group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- function constipation by Romes criteria IV

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sang Yeoup Lee, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: July 20, 2021
• Primary Completion: February 27, 2022
• Study Completion: April 15, 2022
• Last Updated: January 6, 2026

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)