CClinicalTrials.gg
Status unknownNCT02395484Updated May 4, 2015

Metagenome Analysis of Gut Microbiota in CC Patients

An observational study in Constipation, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-04.

Sponsored by Jinling Hospital, China · Observational

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Constipation

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03

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 129 observational studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • constipation

    collect stool samples from constipation patients

  • healthy controls

    collect stool samples from healthy controls patients

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What researchers measure

Primary outcomes

  1. taxonomic and functional characterization of gut microbiota

    Time frame: one year

Secondary outcomes

  1. Gut-microbiota-based constipation classification

    Time frame: one year

  2. constipation-associated gut microbial markers

    Time frame: one year

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Study locations

1 of 1 sites recruiting
  • Jinling Hospital
    Nanjing, Jiangsu 210000, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02395484
Lead sponsor
Jinling Hospital, China
Responsible party
Jianfeng Gong (MD, Jinling Hospital, China) — Principal investigator
First posted
Mar 23, 2015
Start date
Mar 2015
Primary completion
Mar 2016 (estimated)
Completion
Jun 2016 (estimated)
Last update
May 4, 2015

Study contacts

Ning Li, MD
Contact
jinlingh_lining@126.com
+86-25-80860089
Jianfeng Gong, MD
Contact
gongjianfeng@aliyun.com
+86-25-80860036
Chao Ding, MD
principal investigator · Department of Generay Surgery, Jinling hospital
Hongliang Tian, PhD
principal investigator · Department of Generay Surgery, Jinling hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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