Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Phase 4UnknownNCT02614963

Shandong University300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Interventions

Clostridium ButyricumDRUG

Irritable bowel syndrome patients treated with Clostridium Butyricum

placeboDRUG

Irritable bowel syndrome patients treated with placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores

Time frame: 7 months

Secondary Outcomes

IBS patients'quality of life

Quality of life was determined by using IBS-QOL scoring system for patients with IBS.

Time frame: 7 months

Composition of Microorganisms in stool

Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).

Time frame: 7 months

Central Contacts

Li Yanqing, MD,PhD

CONTACT

86-531-82169236 liyanqing@sdu.edu.cn

Data from ClinicalTrials.gov

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