Fecal Microbiota Transplantation Clinical Trial
— FMTFCFCOfficial title:
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 diseaseļ¼but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | IEC of Chengdu Medical College | Chendu |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Chengdu Medical College |
China,
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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