Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics RevestiveĀ® in the Manageā¦ (NCT03562130) | Clinical Trial Compass
CompletedPhase 4
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics RevestiveĀ® in the Management of Short Bowel Syndrome Pediatric Patients
France25 participantsStarted 2018-07-02
Plain-language summary
The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition complications and to achieve the best possible quality of life for the patient
Who can participate
Age range2 Years ā 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Being aged from 2 to 18 years old included ;
* Presenting less than 80 cm of residual small intestine with or without the terminal ileum, ileocecal valve and right colon or having less than 120 cm in case of Short Bowel Syndrome (SBS) caused by Hirschsprung disease;
* Being stable on PN support (inability to significantly reduce PN intake for the last six months before inclusion) ;
* Being dependent on PN for at least 2 years and enterally fed (oral or tube feeding) ;
* Having a normal colonoscopy in the 12 months before screening for children with maintained colon (=SBS type 2 or 3) older than 12 years ;
* Having signed the Informed consent form (or parents or legal representative for minor patients).
Exclusion Criteria:
* Having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ;
* Having a clinically significant untreated intestinal obstruction or active stenosis ;
* Having an unstable absorption due to cystic fibrosis or known DNA abnormalities ;
* Presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ;
* Having an unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of patients who had undergone ventricular or atrial septal defect repair ;
* Having a history of cancer or clinā¦
What they're measuring
1
Decrease in parenteral nutrition: Parenteral Nutrition/Resting Energy Expenditure (PN/REE)