Skip to main content
OpenTrials
Completed

NCT Number: NCT04997187

Effect of Bacillus Coagulans in Adults With With Functional Constipation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Constipation - Functional

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bacillus coagulans group

Dietary Supplement

Bacillus coagulans 400 mg/day for 12 weeks

Control group

Dietary Supplement

Placebo 400 mg/day for 12 weeks

Primary outcomes

  1. constipation visual analogue scale

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. visual analogue scale for irritable bowel syndrome

    Time frame: 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.

  3. irritable bowel syndrome-symptom severity scale

    Time frame: 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.

  4. irritable bowel syndrome-quality-of-life

    Time frame: 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.

  5. fecal microbial diversity

    Time frame: 8 weeks

    using gut microbiome analysis

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2021
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.