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

NCT ID: NCT02984969

Last Updated: 2016-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-02-28

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.

Conditions

Slow Transit Constipation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Slow transit constipation

subjects met the Rome III criteria for STC

No interventions assigned to this group

Healthy subjects

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Gong

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongliang Tian

Role: PRINCIPAL_INVESTIGATOR

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Locations

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianfeng Gong, PhD

Role: CONTACT

Phone: +86-25-80860036

Email: jinlingh_gongjf@126.com

Ning Li

Role: CONTACT

Phone: +86-25-80860089

Email: jinlingh_lining@126.com

Facility Contacts

Jianfeng Gong, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32767153 (View on PubMed)

Other Identifiers

STC-2016-16sRNA

Identifier Type: -

Identifier Source: org_study_id