Fecal Microbiota Transplantation for Chronic Functional Constipation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation

Intervention / Treatment
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* Other: Fecal Microbiota Transplantation
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: subjects voluntarily participate in the trial and sign informed consent; sex is not limited,ranging from 18 to 75 years old; meet the diagnostic criteria for chronic functional constipation in patients; 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; be able to communicate well with the researchers and follow the verification requirements. Exclusion criteria: does not meet the diagnostic criteria; with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases; severe anemia and severe systemic infection; suspected or indeed have alcohol, drug abuse history; pregnancy or are preparing for pregnancy, and breastfeeding women; Those who are unwilling to accept the research measures or other reasons can not cooperate; due to mental disorders can not give adequate informed consent; Participated in other clinical trials within 3 months before the start of the study; researchers believe that participates are not suitable for other reasons in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment for part 1<br>Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1. | Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.<br>* Other names: Fecal Microbiota Transplantation(FMT);|
| Placebo Comparator: Placebo for part 2<br>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<br>* Normal saline and the traditional treatments for chronic functional constipation in part 2<br>* Other names: Normal Saline(NS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events complication rate in all patients in both groups |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of bowel movements per week |  | 4 weeks | 
| Bristol stool scale |  | 4 weeks | 
| 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 | 
| Usage of laxatives or enemas as rescue medication |  | 4 weeks | 
| Histological changes in the intestinal biopsy in both groups. |  | 4 weeks | 
| Microbiota composition |  | 4 weeks | 
| Nitric oxide(NO) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Functional Constipation, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation