Shengjing Hospital
Shenyang, Liaoning, 110004, China
NCT Number: NCT05035784
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.
Looking for future studies?
Notify Me4 year–14 year
All sexes
Interventional
Not applicable
Shenyang, Liaoning, 110004, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .
a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.
Time frame: Baseline
the frequency of defecation without drugs or other auxiliary methods
Time frame: at the end of 4-weeks FMT treatment
the frequency of defecation without drugs or other auxiliary methods
Time frame: at the end of 12 weeks follow-up
the frequency of defecation without drugs or other auxiliary methods
Time frame: Baseline
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).
Time frame: at the end of 4-weeks FMT treatment
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).
Time frame: at the end of 12 weeks follow-up
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).
Time frame: Baseline
the frequency of bowel movements per week
Time frame: at the end of 4-weeks FMT treatment
the frequency of bowel movements per week
Time frame: at the end of 12 weeks follow-up
the frequency of bowel movements per week
Time frame: Baseline
The feelings of children during defecation
Time frame: at the end of 4-weeks FMT treatment
The feelings of children during defecation
Time frame: at the end of 12 weeks follow-up
The feelings of children during defecation
Time frame: Baseline
appearance and wetness of stool
Time frame: at the end of 4-weeks FMT treatment
appearance and wetness of stool
Time frame: at the end of 12 weeks follow-up
appearance and wetness of stool
Time frame: Baseline
The number of children who intentionally control or reduce the frequency of defecation
Time frame: at the end of 4-weeks FMT treatment
The number of children who intentionally control or reduce the frequency of defecation
Time frame: at the end of 12 weeks follow-up
The number of children who intentionally control or reduce the frequency of defecation
Time frame: Baseline
the frequency of fecal incontinence
Time frame: at the end of 4-weeks FMT treatment
the frequency of fecal incontinence
Time frame: at the end of 12 weeks follow-up
the frequency of fecal incontinence
Shengjing Hospital
Other
Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07386795
Chronic Constipation, Constipation - Functional
Beijing, China
View Trial DetailsNCT05917379
Anxiety, Anxiety Disorders
Hefei, Anhui, China
View Trial DetailsNCT05273255
Cancer, Fecal Microbiota Transplantation
Zurich, Switzerland
View Trial DetailsNCT03125564
Colonic Diseases, Colonic Diseases, Functional
Shatin, Hong Kong
View Trial Details