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Effect of Bacillus Coagulans in Adults With With Functional Constipation

Primary Purpose

Constipation - Functional

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bacillus coagulans group
Control group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation - Functional

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bacillus coagulans group

Control group

Arm Description

This group takes Bacillus coagulans for 12 weeks.

This group takes placebo for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
fecal microbial diversity
using gut microbiome analysis

Full Information

First Posted
July 30, 2021
Last Updated
April 10, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04997187
Brief Title
Effect of Bacillus Coagulans in Adults With With Functional Constipation
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
February 27, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bacillus coagulans group
Arm Type
Experimental
Arm Description
This group takes Bacillus coagulans for 12 weeks.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bacillus coagulans group
Intervention Description
Bacillus coagulans 400 mg/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group
Intervention Description
Placebo 400 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
constipation visual analogue scale
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Bristol Stool Form Scale (BSFS) type 3 & 4 ratio (%)
Description
using Bristol Stool Form Scale. The minimum value was 0% and the maximum value was 100%, and higher scores mean a better outcome.
Time Frame
8 weeks
Title
visual analogue scale for irritable bowel syndrome
Description
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.
Time Frame
8 weeks
Title
irritable bowel syndrome-symptom severity scale
Description
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.
Time Frame
8 weeks
Title
irritable bowel syndrome-quality-of-life
Description
using IBS-QOL questionnaire. The minimum value was 0 score and the maximum value was 5 score and higher scores mean a better outcome.
Time Frame
8 weeks
Title
fecal microbial diversity
Description
using gut microbiome analysis
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee, MD, PhD
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Bacillus Coagulans in Adults With With Functional Constipation

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