Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase

Irritable Bowel Syndrome Clinical Trial

Official title:

Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02566629
• Other study ID #: 2015SDU-QILU-G11
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2015
• Last updated: October 1, 2015
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: Shandong University
• Contact: Yanqing Li, MD.PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Analyze microbiota community of irritable bowel syndrome in episodes phase and remission phase.

Description:

The pathophysiology of IBS is incompletely understood, it may involve an altered intestinal microbiota. Since the microflora composition of IBS is various in different studies, The investigators plan to compare the intestinal microbiota of IBS patients in episodes phase and remission phase with healthy controls,trying to find the difference.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• the presence of Rome III criteria for IBS ;

• Patients scheduled for colonoscopy examination or having negative screening examinations

• 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• collect faeces from participants
analyze the fecal microbiota community using 16S rDNA detection technique

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbiota community among IBS patients in episodes phase,remission phase and healthy controls		5 months	Yes
Secondary	quality of life in IBS patients		5 months	Yes