RCE With FMT in the Treatment of Childhood Constipation

Study Overview
=================
Brief Summary
-----------------
Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects, the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the use of PEG increases the risk of fecal incontinence. Additional treatment interventions are still necessary.Enema can act directly on the rectum and distal colon to quickly relieve symptoms of fecal impaction which is considered one of main source of intractable constipation. Children with fecal impaction who received enema had fewer fecal incontinence and diarrhea than children who received PEG. There have been lots of evidence that enema is effective in fecal impaction in children with functional constipation.But there are still cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new treatment method emerging in recent years, which is widely used in the treatment of functional gastrointestinal diseases. FMT has been proved to play a very prominent role in correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment and cascade the body immunity, so as to achieve the therapeutic effect of disease. Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment of childhood constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of retrograde colonic enema with FMT in the treatment of childhood constipation.

Official Title
-----------------
Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation

Conditions
-----------------
Fecal Microbiota Transplantation, Constipation - Functional

Intervention / Treatment
-----------------
* Drug: Fecal supernatant
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 4-14 years old; Roman IV criteria for childhood constipation; After a course of PEG and a course of Chinese medicine treatment was ineffective; Barium enema showing fecal impaction. Exclusion criteria: Congenital and/or acquired intestinal diseases, such as congenital megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumors; Anorectal diseases, such as anal atresia, fistula, abscess, and tumor; Neurological diseases, such as brain and spinal cord diseases; genetic metabolic diseases; psychosocial and behavioral diseases; other systemic diseases; Refused to participate in.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fecal supernatant<br>Fecal supernatant is used for treatment of childhood Constipation | Drug: Fecal supernatant<br>* Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .<br>|
| Placebo Comparator: non-Fecal supernatant<br>Placebo is used for treatment of childhood Constipation | Drug: Placebo<br>* a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of spontaneous bowel movements(SBMs) per week | the frequency of defecation without drugs or other auxiliary methods | Baseline | 
| improvement of spontaneous bowel movements(SBMs) per week | the frequency of defecation without drugs or other auxiliary methods | at the end of 4-weeks FMT treatment | 
| improvement of spontaneous bowel movements(SBMs) per week | the frequency of defecation without drugs or other auxiliary methods | at the end of 12 weeks follow-up | 
| Satisfaction with bowel function | Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no). | Baseline | 
| Satisfaction with bowel function | Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no). | at the end of 4-weeks FMT treatment | 
| Satisfaction with bowel function | Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no). | at the end of 12 weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel movements | the frequency of bowel movements per week | Baseline | 
| Bowel movements | the frequency of bowel movements per week | at the end of 4-weeks FMT treatment | 
| Bowel movements | the frequency of bowel movements per week | at the end of 12 weeks follow-up | 
| Painful or hard bowel movements | The feelings of children during defecation | Baseline | 
| Painful or hard bowel movements | The feelings of children during defecation | at the end of 4-weeks FMT treatment | 
| Painful or hard bowel movements | The feelings of children during defecation | at the end of 12 weeks follow-up | 
| Large diameter or scybalous stools | appearance and wetness of stool | Baseline | 
| Large diameter or scybalous stools | appearance and wetness of stool | at the end of 4-weeks FMT treatment | 
| Large diameter or scybalous stools | appearance and wetness of stool | at the end of 12 weeks follow-up | 
| Excessive volitional stool retention | The number of children who intentionally control or reduce the frequency of defecation | Baseline | 
| Excessive volitional stool retention | The number of children who intentionally control or reduce the frequency of defecation | at the end of 4-weeks FMT treatment | 
| Excessive volitional stool retention | The number of children who intentionally control or reduce the frequency of defecation | at the end of 12 weeks follow-up | 
| Encopresis | the frequency of fecal incontinence | Baseline | 
| Encopresis | the frequency of fecal incontinence | at the end of 4-weeks FMT treatment | 
| Encopresis | the frequency of fecal incontinence | at the end of 12 weeks follow-up |