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Fecal Microbiota Transplantation for Chronic Functional Constipation (FMTFCFC)

Primary Purpose

Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Normal Saline
Sponsored by
First Affiliated Hospital of Chengdu Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Functional Constipation focused on measuring Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. subjects voluntarily participate in the trial and sign informed consent;
  2. sex is not limited,ranging from 18 to 75 years old;
  3. meet the diagnostic criteria for chronic functional constipation in patients;
  4. patients has been ruled out organic diseases of the large intestine within 1 year by colonoscopy or barium enema examination, and stool routine and occult blood examination are normal within 1 month;
  5. be able to communicate well with the researchers and follow the verification requirements.

Exclusion criteria:

  1. does not meet the diagnostic criteria;
  2. with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases;
  3. severe anemia and severe systemic infection;
  4. suspected or indeed have alcohol, drug abuse history;
  5. pregnancy or are preparing for pregnancy, and breastfeeding women;
  6. Those who are unwilling to accept the research measures or other reasons can not cooperate;
  7. due to mental disorders can not give adequate informed consent;
  8. Participated in other clinical trials within 3 months before the start of the study;
  9. researchers believe that participates are not suitable for other reasons in this clinical trial.

Sites / Locations

  • IEC of Chengdu Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treatment for part 1

Placebo for part 2

Arm Description

Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.

The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines.

Outcomes

Primary Outcome Measures

Number of adverse events complication rate in all patients in both groups

Secondary Outcome Measures

Mean number of bowel movements per week
Bristol stool scale
Constipation-related symptoms assessments
Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4.
Usage of laxatives or enemas as rescue medication
Histological changes in the intestinal biopsy in both groups.
Microbiota composition
Nitric oxide(NO)

Full Information

First Posted
January 3, 2017
Last Updated
January 10, 2017
Sponsor
First Affiliated Hospital of Chengdu Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT03018613
Brief Title
Fecal Microbiota Transplantation for Chronic Functional Constipation
Acronym
FMTFCFC
Official Title
Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Chengdu Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.
Detailed Description
Patients who meet the inclusion crit chronic functional constipation will be separated into two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal motility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
Keywords
Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment for part 1
Arm Type
Active Comparator
Arm Description
Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.
Arm Title
Placebo for part 2
Arm Type
Placebo Comparator
Arm Description
The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines.
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
Fecal Microbiota Transplantation(FMT)
Intervention Description
Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Normal Saline(NS)
Intervention Description
Normal saline and the traditional treatments for chronic functional constipation in part 2
Primary Outcome Measure Information:
Title
Number of adverse events complication rate in all patients in both groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean number of bowel movements per week
Time Frame
4 weeks
Title
Bristol stool scale
Time Frame
4 weeks
Title
Constipation-related symptoms assessments
Description
Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4.
Time Frame
4 weeks
Title
Usage of laxatives or enemas as rescue medication
Time Frame
4 weeks
Title
Histological changes in the intestinal biopsy in both groups.
Time Frame
4 weeks
Title
Microbiota composition
Time Frame
4 weeks
Title
Nitric oxide(NO)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: subjects voluntarily participate in the trial and sign informed consent; sex is not limited,ranging from 18 to 75 years old; meet the diagnostic criteria for chronic functional constipation in patients; patients has been ruled out organic diseases of the large intestine within 1 year by colonoscopy or barium enema examination, and stool routine and occult blood examination are normal within 1 month; be able to communicate well with the researchers and follow the verification requirements. Exclusion criteria: does not meet the diagnostic criteria; with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases; severe anemia and severe systemic infection; suspected or indeed have alcohol, drug abuse history; pregnancy or are preparing for pregnancy, and breastfeeding women; Those who are unwilling to accept the research measures or other reasons can not cooperate; due to mental disorders can not give adequate informed consent; Participated in other clinical trials within 3 months before the start of the study; researchers believe that participates are not suitable for other reasons in this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoan Li, Ph.D
Phone
+8613880868858
Email
zqzy1983@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoan Li, Ph.D
Organizational Affiliation
First Affiliated Hospital of Chengdu Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
IEC of Chengdu Medical College
City
Chendu
ZIP/Postal Code
610500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoan Li, Ph.D
Phone
+8613680868858
Email
zqzy1983@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fecal Microbiota Transplantation for Chronic Functional Constipation

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