Metagenome Analysis of Gut Microbiota in CC Patients

May 1, 2015 updated by: Jianfeng Gong, Jinling Hospital, China

Species and Metagenome Analysis of Gut Microbiota in Chronic Constipation Patients

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jinling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

50 faecal samples were obtained from constipation patients and 50 faecal samples were obtained from healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
constipation
collect stool samples from constipation patients
healthy controls
collect stool samples from healthy controls patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
taxonomic and functional characterization of gut microbiota
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Gut-microbiota-based constipation classification
Time Frame: one year
one year
constipation-associated gut microbial markers
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Principal Investigator: Chao Ding, MD, Department of Generay Surgery, Jinling hospital
  • Principal Investigator: Hongliang Tian, PhD, Department of Generay Surgery, Jinling hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (Estimate)

March 23, 2015

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MetagenomeNanjing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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