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

Irritable Bowel Syndrome Clinical Trial

Official title:

The Distribution of Irritable Bowel Syndrome (IBS) Subtypes, Chinese Medicine Pattern and Host-gut Microbiota Metabolic Interactions Associated With IBS Subtypes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822677
• Other study ID #: HKBUIBS2016
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: August 14, 2017
• Start date: July 7, 2016
• Est. completion date: January 30, 2017

Study information

• Verified date: August 2017
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

It is a cross-sectional study to discovery the distribution of IBS subtypes who would like to seek CM treatment and their CM patterns.Serum, urine and stool samples of the participants will be collected from 400-600 IBS participants to explore the host-gut microbiota metabolic interactions associated with IBS subtypes. The primary outcome will be the distribution of IBS subtype and their CM pattern in Hong Kong population. Secondary outcomes will be the host-gut microbiota metabolic interactions associated with IBS subtypes, the relationship between CM pattern and their microbiota and metabolic profiling. The relationship between IBS subtype distribution and other predetermined factors will be assessed, including gender, age, weight, Body Mass Index (BMI), dietary habit, education, economical status, the overall and individual IBS Symptom Severity Scale (IBS-SSS), syndrome of Chinese medicine, QoL assessment and Bristol Stool Scale.For those who had fulfillment of the Structured Clinical Interview for DSM-5 Disorders—(SCID-5), the Hamilton Depression Rating Scale (HAMD-17), Clinical Global Impression-severity (CGI-S), and Self-Rating Depression Scale (SDS) will also be assessed. After the collection of serum, urine and stool samples, bacterial total DNA will be extracted, purified,concentrated,dried and stored for further fecal 16s rRNA sequencing analysis. A number of parameters, including serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP) et al., will be measured in serum. Total BA and BA profiles in serum and feces will be tested as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: January 30, 2017
• Est. primary completion date: January 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 1) 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.

Exclusion Criteria:

• 1) 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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
China	School of Chinese Medicine, Hong Kong Baptist University	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Distribution of IBS Subtype and Their CM Pattern in Hong Kong Population.		one year
Secondary	the Host-gut Microbiota Metabolic Interactions Associated with IBS Subtypes		one year
Secondary	the Relationship Between CM Pattern and Their Microbiota		one year
Secondary	the relationship between CM pattern and metabolic profiling		one year