Metagenome Analysis of Gut Microbiota in CC Patients

Species and Metagenome Analysis of Gut Microbiota in Chronic Constipation Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02395484

Enrollment

Registered

2015-03-23

Start date

2015-03-31

Completion date

2016-06-30

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
taxonomic and functional characterization of gut microbiota	one year

Secondary

Measure	Time frame
Gut-microbiota-based constipation classification	one year
constipation-associated gut microbial markers	one year

Countries

China

Contacts

Primary ContactNing Li, MD

jinlingh_lining@126.com+86-25-80860089

Backup ContactJianfeng Gong, MD

gongjianfeng@aliyun.com+86-25-80860036

Outcome results