Effect of Bacillus Coagulans in Adults With With Functional Constipation

• Sponsor: Pusan National University Yangsan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04997187
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 9.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation - Functional	Dietary Supplement: Bacillus coagulans group; Dietary Supplement: Control group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 20, 2021
• Actual Primary Completion Date: Mar 30, 2022
• Actual Study Completion Date: Apr 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bacillus coagulans group This group takes Bacillus coagulans for 12 weeks.	Dietary Supplement: Bacillus coagulans group; Bacillus coagulans 400 mg/day for 12 weeks
Placebo Comparator: Control group This group takes placebo for 12 weeks.	Dietary Supplement: Control group; Placebo 400 mg/day for 12 weeks

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. fecal microbial diversity [8 weeks]

   using gut microbiome analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do	Korea, Republic of	50612

Sponsors and Collaborators

• Pusan National University Yangsan Hospital

Investigators

• Principal Investigator: Sang Yeoup Lee, MD, PhD, Pusan National University Yangsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
• ClinicalTrials.gov Identifier: NCT04997187
• Other Study ID Numbers: 02-2021-008
• First Posted: Aug 9, 2021
• Last Update Posted: Apr 26, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Constipation

Study Results

No Results Posted as of Apr 26, 2022