Effect of Bacillus Coagulans in Adults With With Functional Constipation

Phase

N/A

Condition

Constipation

Treatment

N/A

Clinical Study ID

NCT04997187

02-2021-008

Ages 19-75
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

function constipation by Romes criteria IV

Exclusion

Exclusion Criteria:

Abnormal liver or renal function (more than twice the normal upper limit of theresearch 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 ormyocardial infarction within 6 months
History of structural abnormalities of colon within 4 year
History of medication for probiotics and psychiatric diseases such as severedepression, schizophrenia, drug intoxication.
Alcohol abuser
Allergic reaction to this test food
Those who participated in other drug clinical trials within 1 month from the screeningdate.
Severe gastrointestinal symptoms such as heartburn and indigestion
Those who are pregnant, lactating, or plan to become pregnant during the clinicaltrial
Those who are judged to be unsuitable by the PI for other reasons

Study Design

July 20, 2021

April 15, 2022

Study 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.

Connect with a study center

Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do 50612
Korea, Republic of
Site Not Available

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