Fecal Microbiota Transplantation for Chronic Functional Constipation

Fecal Microbiota Transplantation Clinical Trial

— FMTFCFC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018613
• Other study ID #: FMT-CFC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 3, 2017
• Last updated: January 10, 2017
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: December 2016
• Source: First Affiliated Hospital of Chengdu Medical College
• Contact: Xiaoan Li, Ph.D
• Phone: +8613880868858
• Email: zqzy1983[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Functional Constipation
• Constipation
• Dysbiosis
• Fecal Microbiota Transplantation
• Intestinal Bacteria Flora Disturbance

Intervention

Other:
• Fecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
• Normal Saline
Normal saline and the traditional treatments for chronic functional constipation in part 2

Locations

Country	Name	City	State
China	IEC of Chengdu Medical College	Chendu

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chengdu Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events complication rate in all patients in both groups		3 months	No
Secondary	Mean number of bowel movements per week		4 weeks	No
Secondary	Bristol stool scale		4 weeks	No
Secondary	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	No
Secondary	Usage of laxatives or enemas as rescue medication		4 weeks	No
Secondary	Histological changes in the intestinal biopsy in both groups.		4 weeks	No
Secondary	Microbiota composition		4 weeks	No
Secondary	Nitric oxide(NO)		4 weeks	No