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Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Primary Purpose

Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Clostridium Butyricum
placebo
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Clostridium Butyricum

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Gastroenterology, Qilu Hospital, Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clostridium Butyricum group

Placebo group

Arm Description

Irritable bowel syndrome patients treated with Clostridium Butyricum

Irritable bowel syndrome patients treated with placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 23, 2015
Last Updated
May 15, 2016
Sponsor
Shandong University
Collaborators
Linyi People's Hospital, Taian City Central Hospital, Qingdao Eastsea Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02614963
Brief Title
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
Official Title
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome: A Randomized, Double-blinded,Placebo- Controlled Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
Linyi People's Hospital, Taian City Central Hospital, Qingdao Eastsea Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Clostridium Butyricum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clostridium Butyricum group
Arm Type
Experimental
Arm Description
Irritable bowel syndrome patients treated with Clostridium Butyricum
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Irritable bowel syndrome patients treated with placebo
Intervention Type
Drug
Intervention Name(s)
Clostridium Butyricum
Intervention Description
Irritable bowel syndrome patients treated with Clostridium Butyricum
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Irritable bowel syndrome patients treated with placebo
Primary Outcome Measure Information:
Title
the changes of Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) scores
Time Frame
7 months
Secondary Outcome Measure Information:
Title
IBS patients'quality of life
Description
Quality of life was determined by using IBS-QOL scoring system for patients with IBS.
Time Frame
7 months
Title
Composition of Microorganisms in stool
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yanqing, MD,PhD
Phone
86-531-82169236
Email
liyanqing@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yanqing, MD,PhD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD, PhD
Phone
86-531-82169236
Ext
82169508
Email
liyanqing@sdu.edu.cn

12. IPD Sharing Statement

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Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

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