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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03018613
Other study ID # FMT-CFC
Secondary ID
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 diseaseļ¼Œbut 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


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
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