Chronic Functional Constipation, Fecal Microbiota Transplantation, Intestinal Bacteria Flora Disturbance
Conditions
Keywords
Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
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.
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.
Interventions
OTHERFecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
OTHERNormal Saline
Normal saline and the traditional treatments for chronic functional constipation in part 2
Sponsors
First Affiliated Hospital of Chengdu Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events complication rate in all patients in both groups | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bristol stool scale | 4 weeks | — |
| Constipation-related symptoms assessments | 4 weeks | Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4. |
| Usage of laxatives or enemas as rescue medication | 4 weeks | — |
| Mean number of bowel movements per week | 4 weeks | — |
| Microbiota composition | 4 weeks | — |
| Nitric oxide(NO) | 4 weeks | — |
| Histological changes in the intestinal biopsy in both groups. | 4 weeks | — |
Countries
China
Contacts
Primary ContactXiaoan Li, Ph.D
Outcome results
None listed