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Fecal Microbiota Transplantation for Constipation

Primary Purpose

Gut Microbiota, Constipation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota suspension
Sponsored by
The Second Hospital of Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gut Microbiota focused on measuring difficult defecation, fecal microbiota transplantation, stool pattern

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fecal microbiota transplantation (FMT)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 7, 2017
Last Updated
October 11, 2017
Sponsor
The Second Hospital of Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03308461
Brief Title
Fecal Microbiota Transplantation for Constipation
Official Title
Fecal Microbiota Transplantation for Constipation With Difficult Defecation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Hospital of Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gut Microbiota, Constipation
Keywords
difficult defecation, fecal microbiota transplantation, stool pattern

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fecal microbiota transplantation (FMT)
Arm Type
Experimental
Arm Description
Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT.
Intervention Type
Drug
Intervention Name(s)
Fecal Microbiota suspension
Intervention Description
The prepared microbiota suspension was infused into mid-gut.
Primary Outcome Measure Information:
Title
defecation frequency
Description
frequency of defecation per week
Time Frame
12 weeks
Title
stool consistency
Description
The category of stool consistency score based on the BSS (Bristol Stool Form Scale)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Facility Information:
Facility Name
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26069274
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.
Results Reference
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PubMed Identifier
26276682
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. No abstract available.
Results Reference
background
PubMed Identifier
15466518
Citation
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.
Results Reference
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Fecal Microbiota Transplantation for Constipation

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