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

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

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.

Study Overview

• Status: Unknown
• Conditions: Slow Transit Constipation

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Participation Criteria

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

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

Description

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:

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy subjects; Healthy controls
Slow transit constipation; subjects met the Rome III criteria for STC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Investigators: Principal Investigator: Hongliang Tian, Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: November 20, 2016
• First Submitted That Met QC Criteria: December 4, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: STC-2016-16sRNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED