Metagenome Analysis of Gut Microbiota in CC Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Constipation

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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constipation

collect stool samples from constipation patients

No interventions assigned to this group

healthy controls

collect stool samples from healthy controls patients

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes