Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome: A Randomized, Double-blinded,Placebo- Controlled Multicenter Study

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

Study Overview

• Status: Unknown
• Conditions: Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Clostridium Butyricum; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University
      • Contact: Yanqing Li, MD, PhD; Phone Number: 82169508 86-531-82169236; Email: liyanqing@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clostridium Butyricum group; Irritable bowel syndrome patients treated with Clostridium Butyricum	Drug: Clostridium Butyricum; Irritable bowel syndrome patients treated with Clostridium Butyricum
Placebo Comparator: Placebo group; Irritable bowel syndrome patients treated with placebo	Drug: placebo; Irritable bowel syndrome patients treated with placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS patients'quality of life	Quality of life was determined by using IBS-QOL scoring system for patients with IBS.	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).	7 months

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Linyi People's Hospital; Taian City Central Hospital; Qingdao Eastsea Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Li Yanqing, MD,PhD, Qilu Hospital，Shandong University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Clostridium Butyricum
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 2015SDU-QILU-G13