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Status unknownNCT02984969Updated Dec 7, 2016

Using 16S rRNA Gene Sequencing Analysis Intestinal Microbiota in Constipation Patients

An observational study in Slow Transit 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 2016-12-07.

Sponsored by Jinling Hospital, China · Observational

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
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Study summary

Constipation is a frequent, chronic gastroenterological problem that has many varied symptoms and thus has several clinical definitions. According to the Rome III criteria for chronic constipation, almost 16% of all adults are affected by chronic constipation worldwide, and it is more prevalent and symptomatic in women and elderly people. Slow transit constipation (STC) is the major category and is characterized by a decreased rate of colonic transit.

Recently, many researchers have focused on the relationship between intestinal microbiota and constipation and have demonstrated that intestinal microbiota contribute to the pathophysiology of functional gastrointestinal disorders.

Thus, there is a need for an improved understanding of gut microbiota composition in constipation patients and for the potential role played by the gut microbiota in the etiology of STC.To achieve this goal the investigators characterized and compared the intestinal microbiota among carefully selected patients with constipation that were clinically categorized based on Rome III criteria, and healthy controls using high throughput pyrosequencing of the 16S rRNA gene and a conservative approach to detect quantitative changes in the relative abundances of taxa.

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Conditions studied

  • Slow Transit 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 20 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

A total of 18 subjects met the Rome III criteria for STC and 17 healthy controls were recruit from Jinling Hospital, a teaching hospital of Nanjing University

Inclusion criteria

  1. Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;
  2. Age > 18 years;
  3. BMI: 18.5-25 kg/m2;
  4. Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) > 48 hours);
  5. Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
  6. No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast;
  7. Disease duration > 1 year;
  8. Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;

Exclusion criteria

Exclusion Criteria:

  1. Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);
  2. History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ;
  3. Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
  4. Previous proctological or perianal surgery;
  5. A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
  6. Pregnant or breast-feeding women;
  7. Infection with enteric pathogen;
  8. Usage of probiotics, prebiotics and/or synbiotics within the last month;
  9. Usage of antibiotics and/or PPIs within the last 3 months;
  10. Smoking or alcohol addiction within the last 3 months;
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Slow transit constipation

    subjects met the Rome III criteria for STC

  • Healthy subjects

    Healthy controls

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What researchers measure

Primary outcomes

  1. Fecal microbiota sequence

    The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods at BGI-Shenzhen

    Time frame: Within a week after enroll

Secondary outcomes

  1. Stool short-chain fatty acids (SCFAs)

    The stool short-chain fatty acids (SCFAs) were extracted and quantitatively analysed by gas chromatography-mass spectrometry (GC-MS)

    Time frame: Within a week after enroll

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Study locations

1 of 1 sites recruiting
  • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
    Nanjing, Jiangsu 210000, China
    Recruiting
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References and documents

Publications

  • Tian H, Chen Q, Yang B, Qin H, Li N. Analysis of Gut Microbiome and Metabolite Characteristics in Patients with Slow Transit Constipation. Dig Dis Sci. 2021 Sep;66(9):3026-3035. doi: 10.1007/s10620-020-06500-2. Epub 2020 Aug 7. PubMed 32767153 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2016, 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
NCT02984969
Lead sponsor
Jinling Hospital, China
Responsible party
Jianfeng Gong (PhD, Jinling Hospital, China) — Principal investigator
First posted
Dec 7, 2016
Start date
Jul 2016
Primary completion
Nov 2016
Completion
Feb 2017 (estimated)
Last update
Dec 7, 2016

Study contacts

Jianfeng Gong, PhD
Contact
jinlingh_gongjf@126.com
+86-25-80860036
Ning Li
Contact
jinlingh_lining@126.com
+86-25-80860089
Hongliang Tian
principal investigator · Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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