Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02614963
• Other study ID #: 2015SDU-QILU-G13
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 23, 2015
• Last updated: November 24, 2015
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2015
• Source: Shandong University
• Contact: Li Yanqing, MD,PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission of the PRC
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Clostridium Butyricum
Irritable bowel syndrome patients treated with Clostridium Butyricum
• placebo
Irritable bowel syndrome patients treated with placebo

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (4)

Lead Sponsor	Collaborator
Shandong University	Linyi People's Hospital, Qingdao Eastsea Pharmaceutical Co., Ltd., Taian City Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores		7 months	No
Secondary	IBS patients'quality of life	Quality of life was determined by using IBS-QOL scoring system for patients with IBS.	7 months	No
Secondary	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	No