Fecal Microbiota Transplantation for Chronic Functional Constipation (FMTFCFC)

Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism

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.

Study Overview

• Status: Unknown
• Conditions: Intestinal Bacteria Flora Disturbance; Fecal Microbiota Transplantation; Chronic Functional Constipation
• Intervention / Treatment: Other: Fecal Microbiota Transplantation; Other: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Chendu, China, 610500
    • Recruiting
    • IEC of Chengdu Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: treatment for part 1; Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.	Other: Fecal Microbiota Transplantation; Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.; Other Names: Fecal Microbiota Transplantation(FMT)
PLACEBO_COMPARATOR: Placebo for part 2; The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines.	Other: Normal Saline; Normal saline and the traditional treatments for chronic functional constipation in part 2; Other Names: Normal Saline(NS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events complication rate in all patients in both groups	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chengdu Medical College

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (ESTIMATE): January 12, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Chronic Functional Constipation; Intestinal Bacteria Flora Disturbance
• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Constipation; Dysbiosis
• Other Study ID Numbers: FMT-CFC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO