Fecal Microbiota Transplantation for Chronic Functional Constipation (FMTFCFC)

• ClinicalTrials.gov Identifier: NCT03018613
• Recruitment Status: Unknown
• First Posted: January 12, 2017
• Last Update Posted: January 12, 2017
• Sponsor: First Affiliated Hospital of Chengdu Medical College
• Information provided by (Responsible Party): First Affiliated Hospital of Chengdu Medical College

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.

Condition or disease	Intervention/treatment	Phase
Chronic Functional Constipation; Intestinal Bacteria Flora Disturbance; Fecal Microbiota Transplantation	Other: Fecal Microbiota Transplantation; Other: Normal Saline	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism
• Study Start Date: July 2016
• Estimated Primary Completion Date: July 2018
• Estimated Study Completion Date: July 2019

Arms and Interventions

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 Name: 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 Name: Normal Saline(NS)

Outcome Measures

Primary Outcome Measures :

1. Number of adverse events complication rate in all patients in both groups [ Time Frame: 3 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Contacts

Contact: Xiaoan Li, Ph.D; +8613880868858; zqzy1983@163.com

Locations

China

IEC of Chengdu Medical College; Recruiting

Chendu, China, 610500

Contact: Xiaoan Li, Ph.D +8613680868858 zqzy1983@163.com

Sponsors and Collaborators

First Affiliated Hospital of Chengdu Medical College

Investigators

• Study Chair: Xiaoan Li, Ph.D; First Affiliated Hospital of Chengdu Medical College

More Information

• Responsible Party: First Affiliated Hospital of Chengdu Medical College
• ClinicalTrials.gov Identifier: NCT03018613
• Other Study ID Numbers: FMT-CFC
• First Posted: January 12, 2017
• Last Update Posted: January 12, 2017
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by First Affiliated Hospital of Chengdu Medical College:

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

Additional relevant MeSH terms:

Constipation; Dysbiosis; Signs and Symptoms, Digestive; Pathologic Processes