Effect of Bacillus Coagulans in Adults With With Functional Constipation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Bacillus Coagulans on Various Symptoms and Fecal Microbial Diversity in Adults With With Functional Constipation: a Randomized, Double-blinded, Placebo-controlled Trial

Conditions
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Constipation - Functional

Intervention / Treatment
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* Dietary Supplement: Bacillus coagulans group
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bacillus coagulans group<br>This group takes Bacillus coagulans for 12 weeks. | Dietary Supplement: Bacillus coagulans group<br>* Bacillus coagulans 400 mg/day for 12 weeks<br>|
| Placebo Comparator: Control group<br>This group takes placebo for 12 weeks. | Dietary Supplement: Control group<br>* Placebo 400 mg/day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| 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. | 8 weeks | 
| 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. | 8 weeks | 
| 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. | 8 weeks | 
| fecal microbial diversity | using gut microbiome analysis | 8 weeks |