Fecal Microbiota Transplantation for Constipation

Constipation Clinical Trial

Official title:

Fecal Microbiota Transplantation for Constipation With Difficult Defecation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308461
• Other study ID #: FMT-CN-160107
• Status: Completed
• Phase: N/A
• First received: October 7, 2017
• Last updated: October 11, 2017
• Start date: May 1, 2013
• Est. completion date: May 1, 2017

Study information

• Verified date: May 2016
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up after FMT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

Inclusion Criteria:

1. age between 14-80 years old;

2. 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).

Exclusion Criteria:

1. difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders);

2. with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD);

3. pregnant or breast-feeding women;

4. 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.

Related Conditions & MeSH terms

• Constipation
• Gut Microbiota

Intervention

Drug:
• Fecal Microbiota suspension
The prepared microbiota suspension was infused into mid-gut.

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	defecation frequency	frequency of defecation per week	12 weeks
Primary	stool consistency	The category of stool consistency score based on the BSS (Bristol Stool Form Scale)	12 weeks