Metagenome Analysis of Gut Microbiota in CC Patients

• Conditions: Constipation

• Registration Number: NCT02395484
• Lead Sponsor: Jinling Hospital, China

Brief Summary

Constipation is a heterogeneous and multifactorial disease, influenced by a number of different genetic and environmental factors. By applying the standard two-stage GWAS strategy to design and carry out a metagenome-wide association study (MGWAS) to find the relationship between gut microbiota and constipation, to identify disease-associated metagenomic markers.

Detailed Description

This study is a two-stage case-control metagenome-wide association study (MGWAS) based on deep next-generation shotgun sequencing of DNA extracted from the stool samples from a total of 50 Chinese constipation patients and healthy controls.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-23
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-01
• Last Update Posted: 2015-05-04
• Primary Completion: 2016-03
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Chronic constipation according to Rome III criteria;
2. Age ≥ 18 years;
3. BMI: 18.5-25kg/m2;

Exclusion Criteria

1. Bowel constipation due to innate factor (e.g. megacolon) or secondary interventions (e.g. drugs, endocrine, metabolic, neurologic or psychologic disorders);
2. History or evidence of gastrointestinal diseases (e.g. cancer, inflammatory bowel diseases);
3. Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
4. Previous proctological or perianal surgery;
5. Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA classification;
6. A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
7. Pregnant or breast-feeding women;
8. Infection with enteric pathogen;
9. Usage of probiotics, prebiotics, antibiotics or PPIs within the last month;
10. Smoking or alcohol addiction within the last 3 months;
11. Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
12. Disease or therapy with drugs (e.g. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
taxonomic and functional characterization of gut microbiota	one year

Secondary Outcome Measures

Name	Time	Method
Gut-microbiota-based constipation classification	one year
constipation-associated gut microbial markers	one year

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China