A Cross-sectional Study on IBS Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions

NCT02822677 | Completed DMC

• 1 other identifier: HKBUIBS2016
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek TCM treatment and their TCM patterns. At the same time, the investigators will also collect the serum, urine and stool samples of the participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• the Distribution of IBS Subtype and Their CM Pattern in Hong Kong Population.

  one year

Secondary Outcomes (3)

• the Host-gut Microbiota Metabolic Interactions Associated with IBS Subtypes

  one year

• the Relationship Between CM Pattern and Their Microbiota

  one year

• the relationship between CM pattern and metabolic profiling

  one year

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBS Patients

You may qualify if:

• \) meet of diagnosis of IBS(ROME 4); 2) age of 18 to 65 years (inclusive); 3) IBS Symptom Severity Scale \[17\] (IBS-SSS) \> 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period; 4) Normal colonic evaluation (colonoscopy or barium enema) within 5 years; 5) Written informed consent.

You may not qualify if:

• \) pregnancy or breast-feeding; 2) medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases; 3) Having suicidal ideas or attempts or aggressive behavior; 4) Use of medications known to influence gastrointestinal transit.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

School of Chinese Medicine, Hong Kong Baptist University

Hong Kong, Hong Kong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum: The participants will be instructed to meet fasting for the blood sample collection and 15ml whole blood will be drawn from the participants. Stool: Fecal samples should be naturally excreted from subjects (500ml at least) and should be collected without mixing with urine, sanitizer and sewage. Urine: Mid-stream morning urine will be collected.

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhao-xiang Bian, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 4, 2016
• Study Start: July 7, 2016
• Primary Completion: January 16, 2017
• Study Completion: January 30, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

CN (1)