Using 16S rRNA Gene Sequencing Analysis Intestinal Microb... | NCT02984969

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

NCT02984969

Sponsor

Jinling Hospital, China

Status

Unknown status

Last Update Posted

Dec 7, 2016Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Slow Transit Constipation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Feb 2017Estimated

First Submitted Date

Nov 20, 2016

First Submission Date that Met QC Criteria

Dec 4, 2016

First Posted Date

Dec 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2016

Last Update Posted Date

Dec 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Slow transit constipation		subjects met the Rome III criteria for STC
Healthy subjects		Healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fecal microbiota sequence	The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods at BGI-Shenzhen	Within a week after enroll

Secondary Outcomes

Measure	Description	Time Frame
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)	Within a week after enroll

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
Age > 18 years;
BMI: 18.5-25 kg/m2;
Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) > 48 hours);
Normal anorectal manometry, with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
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;
Disease duration > 1 year;
Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfeng Gong, PhD	Contact	+86-25-80860036		jinlingh_gongjf@126.com
Ning Li	Contact	+86-25-80860089		jinlingh_lining@126.com

Overall Officials

Name	Affiliation	Role
Hongliang Tian	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Recruiting	Nanjing	Jiangsu	210000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32767153	Derived	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.