Fecal Microbiota Transplantation for Constipation

NCT03308461 | Completed DMC

• 1 other identifier: FMT-CN-160107
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation.

Conditions

Gut Microbiota; Constipation

Keywords

difficult defecation; fecal microbiota transplantation; stool pattern

Outcome Measures

Primary Outcomes (2)

• defecation frequency

  frequency of defecation per week

  12 weeks

• stool consistency

  The category of stool consistency score based on the BSS (Bristol Stool Form Scale)

  12 weeks

Study Arms (1)

Fecal microbiota transplantation (FMT)

EXPERIMENTAL

Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT.

Drug: Fecal Microbiota suspension

Interventions

Fecal Microbiota suspension DRUG

The prepared microbiota suspension was infused into mid-gut.

Fecal microbiota transplantation (FMT)

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 14-80 years old;
• difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation).

You may not qualify if:

• difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);
• with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);
• pregnant or breast-feeding women;
• infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 weeks.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Related Publications (3)

• Vandeputte D, Falony G, Vieira-Silva S, Tito RY, Joossens M, Raes J. Stool consistency is strongly associated with gut microbiota richness and composition, enterotypes and bacterial growth rates. Gut. 2016 Jan;65(1):57-62. doi: 10.1136/gutjnl-2015-309618. Epub 2015 Jun 11.

  PMID: 26069274 BACKGROUND

• Tigchelaar EF, Bonder MJ, Jankipersadsing SA, Fu J, Wijmenga C, Zhernakova A. Gut microbiota composition associated with stool consistency. Gut. 2016 Mar;65(3):540-2. doi: 10.1136/gutjnl-2015-310328. Epub 2015 Aug 14. No abstract available.

  PMID: 26276682 BACKGROUND

• Duncan SH, Louis P, Flint HJ. Lactate-utilizing bacteria, isolated from human feces, that produce butyrate as a major fermentation product. Appl Environ Microbiol. 2004 Oct;70(10):5810-7. doi: 10.1128/AEM.70.10.5810-5817.2004.

  PMID: 15466518 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Gastroenterology

Study Record Dates

• First Submitted: October 7, 2017
• First Posted: October 12, 2017
• Study Start: May 1, 2013
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 12, 2017

Record last verified: 2016-05

Locations

CN (1)