Fecal Microbiota Transplantation for Constipation

Not Applicable

Completed

• Conditions: Gut Microbiota; Constipation
• Interventions: Drug: Fecal Microbiota suspension

• Registration Number: NCT03308461
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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.

Detailed 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.

Study Timeline

• Study Start: 2013-05-01
• Status Verified: 2016-05
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Study First Submitted: 2017-10-07
• Study First Submitted QC: 2017-10-11
• Last Update Submitted: 2017-10-11
• Study First Posted: 2017-10-12
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal microbiota transplantation (FMT)	Fecal Microbiota suspension	Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT.

Primary Outcome Measures

Name	Time	Method
stool consistency	12 weeks	The category of stool consistency score based on the BSS (Bristol Stool Form Scale)
defecation frequency	12 weeks	frequency of defecation per week

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China