Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

NCT ID: NCT02614963

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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Conditions

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Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clostridium Butyricum group

Irritable bowel syndrome patients treated with Clostridium Butyricum

Group Type EXPERIMENTAL

Clostridium Butyricum

Intervention Type DRUG

Irritable bowel syndrome patients treated with Clostridium Butyricum

Placebo group

Irritable bowel syndrome patients treated with placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Irritable bowel syndrome patients treated with placebo

Interventions

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Clostridium Butyricum

Irritable bowel syndrome patients treated with Clostridium Butyricum

Intervention Type DRUG

placebo

Irritable bowel syndrome patients treated with placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linyi People's Hospital

OTHER

Sponsor Role collaborator

Taian City Central Hospital

OTHER

Sponsor Role collaborator

Qingdao Eastsea Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Yanqing, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Yanqing, MD,PhD

Role: CONTACT

86-531-82169236

Facility Contacts

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Yanqing Li, MD, PhD

Role: primary

86-531-82169236 ext. 82169508

Other Identifiers

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2015SDU-QILU-G13

Identifier Type: -

Identifier Source: org_study_id

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