Microbiota Community of Irritable Bowel Syndrome in Episodes and Remission Phase

NCT02566629 | Unknown DMC

• 1 other identifier: 2015SDU-QILU-G11
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome

Keywords

microbiota community; IBS

Outcome Measures

Primary Outcomes (1)

• microbiota community among IBS patients in episodes phase,remission phase and healthy controls

  5 months

Secondary Outcomes (1)

• quality of life in IBS patients

  5 months

Study Arms (3)

IBS patients in episodes phase

collect faeces from IBS patients in episodes remission phase

Other: collect faeces from participants

IBS patients in remission phase

collect faeces from IBS patients in remission phase

Other: collect faeces from participants

healthy controls

collect faeces from healthy controls

Other: collect faeces from participants

Interventions

collect faeces from participants OTHER

analyze the fecal microbiota community using 16S rDNA detection technique

IBS patients in episodes phase; IBS patients in remission phase; healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who fulfil the Rome III criteria of irritable bowel syndrome in Qilu Hospital outpatient

You may qualify if:

• 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

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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

extract 16S rDNA from fecal microflora

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yanqing Li, MD.PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqing Li, MD.PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 2, 2015
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

CN (1)