Effect of Bacillus Coagulans in Adults With With Function... | NCT04997187

Studies
Effect of Bacillus Coagulans in Adults With With Functional Constipation

NCT04997187

Sponsor

Pusan National University Yangsan Hospital

Status

Completed

Last Update Posted

Jan 6, 2026Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Constipation - Functional

Interventions

Bacillus coagulans group
Control group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2021Actual

Primary Completion Date

Feb 27, 2022Actual

Completion Date

Apr 15, 2022Actual

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2025

Last Update Posted Date

Jan 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bacillus coagulans group	Dietary Supplement	Bacillus coagulans 400 mg/day for 12 weeks	Bacillus coagulans group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Bristol Stool Form Scale (BSFS) type 1 & 2 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
visual analogue scale for irritable bowel syndrome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang Yeoup Lee, MD, PhD	Pusan National University Yangsan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Yangsan Hospital		Yangsan	Gyeungsangnam-do	50612	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D035061	Control Groups

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design

Browse Leaves

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Browse Branches

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