NCT02614963

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

November 23, 2015

Last Update Submit

May 15, 2016

Conditions

Effect of Clostridium Butyricum in Treating Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeClostridium Butyricum

Outcome Measures

Primary Outcomes (1)

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

    7 months

Secondary Outcomes (2)

  • IBS patients'quality of life

    7 months

  • Composition of Microorganisms in stool

    7 months

Study Arms (2)

Clostridium Butyricum group

EXPERIMENTAL

Irritable bowel syndrome patients treated with Clostridium Butyricum

Drug: Clostridium Butyricum

Placebo group

PLACEBO COMPARATOR

Irritable bowel syndrome patients treated with placebo

Drug: placebo

Interventions

Clostridium ButyricumDRUG

Irritable bowel syndrome patients treated with Clostridium Butyricum

Clostridium Butyricum group
placeboDRUG

Irritable bowel syndrome patients treated with placebo

Placebo group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the presence of Rome III criteria for IBS ;
  • Aged between 18 and 65 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

phosphatidyltransferase, Clostridium butyricum

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Li Yanqing, MD,PhD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, MD,PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 25, 2015

Study Start

December 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-03

Locations

CN(1)