Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Shandong University

Status and phase: Unknown; Phase 4

Conditions: Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Treatments: Drug: placebo; Drug: Clostridium Butyricum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02614963

2015SDU-QILU-G13

Details and patient eligibility

About

Clostridium Butyricum might be an effective drug in treating irritable bowel syndrome

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the presence of Rome III criteria for IBS ;
• Aged between 18 and 65 years old

Exclusion criteria

• Antibiotic, probiotic or laxative usage within 4 weeks.
• organic gastrointestinal diseases
• Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
• pregnancy or lactation.
• previous major or complicated abdominal surgery.
• severe endometriosis and dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Clostridium Butyricum group

Experimental group

Description:

Irritable bowel syndrome patients treated with Clostridium Butyricum

Treatment:

Drug: Clostridium Butyricum

Placebo group

Placebo Comparator group

Description:

Irritable bowel syndrome patients treated with placebo

Treatment:

Drug: placebo