Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05035784
Study type Interventional
Source Shengjing Hospital
Contact Shucheng ZHANG
Phone 86-24-96615-57911
Email [email protected]
Status Recruiting
Phase N/A
Start date August 3, 2019
Completion date March 3, 2022

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04436874 - Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease N/A
Recruiting NCT03325855 - Fecal Microbiota Transplant National Registry
Not yet recruiting NCT05035342 - Fecal Transplantation to Eradicate Colonizing Emergent Superbugs Phase 3
Recruiting NCT02318147 - Fecal Microbiota Transplantation for Pancreatitis With Infectious Complications(FMTPIC) Phase 1
Recruiting NCT01790061 - Standardized Fecal Microbiota Transplantation for Ulcerative Colitis Phase 2/Phase 3
Completed NCT02318134 - Fecal Microbiota Transplantation for Pancreatitis Phase 2
Recruiting NCT04173208 - Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study N/A
Recruiting NCT04577729 - The IRMI-FMT Trial N/A
Not yet recruiting NCT02435160 - The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT04837313 - Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation N/A
Recruiting NCT04861649 - Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition N/A
Not yet recruiting NCT04078581 - Profiling Fecal Samples for Selection of Donors of Feces N/A
Recruiting NCT04285424 - FMT for Steroid Resistant Gut Acute GVHD Early Phase 1
Withdrawn NCT03527056 - Pilot Study Using Oral Capsule FMT to Decolonize GI CRE Early Phase 1
Recruiting NCT03016780 - Fecal Microbiota Transplantation for Ulcerative Colitis Phase 1/Phase 2
Recruiting NCT03018613 - Fecal Microbiota Transplantation for Chronic Functional Constipation Phase 1/Phase 2
Recruiting NCT03214289 - Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease Phase 1
Recruiting NCT03804931 - Fecal Microbiota Transplantation for Ulcerative Colitis Phase 2/Phase 3
Recruiting NCT04706611 - Efficacy and Safety of Fecal Microbiota Transplantation N/A
Terminated NCT03350178 - Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY Phase 2