Metagenome Analysis of Gut Microbiota in CC Patients

Constipation Clinical Trial

Official title:

Species and Metagenome Analysis of Gut Microbiota in Chronic Constipation Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02395484
• Other study ID #: MetagenomeNanjing
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2015
• Last updated: May 1, 2015
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2015
• Source: Jinling Hospital, China
• Contact: Ning Li, MD
• Phone: +86-25-80860089
• Email: jinlingh_lining[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	taxonomic and functional characterization of gut microbiota		one year	No
Secondary	Gut-microbiota-based constipation classification		one year	No
Secondary	constipation-associated gut microbial markers		one year	No