Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's Disease (Buty-Hirsch)
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|ClinicalTrials.gov Identifier: NCT03660176|
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Hirschsprung's disease (HD) is a rare disease defined as a congenital absence of enteric ganglia, resulting usually in neonatal bowel obstruction. The current treatment is the operative removal of the aganglionic bowel and anastomosis to the ganglionic zone considered as 'healthy'. However, postoperative course remains unpredictable.
Functional intestinal disorders are present in up to 45% of patients and can occur in the immediate postoperative period or few weeks/years later.
Until now, there are neither predictive factors of postoperative digestive complications nor established treatment for postoperative dysmotility in HD. Abnormalities in enteric nervous system (ENS) phenotype and functions in the 'healthy' ganglionic segment are increasingly suspected to be directly responsible for postoperative intestinal dysfunctions in HD. Therefore, approaches aimed at restoring the nitrergic phenotype could be of major therapeutical interest. Among targets regulating the nitrergic phenotype of ENS are the microbiota and/or derived metabolites. Indeed preclinical animal models deficient in bacterial sensing molecules have a loss of nitrergic neurons and reduced colonic transit. Conversely, microbiota transfer to newborn germ-free mice restored colonic transit time. Alternatively the investigators has shown that bacterial metabolites such as short-chain fatty acids, in particular butyrate, can increase nitrergic phenotype and enhance colonic motility in a gut immaturity animal model. Therefore the investigators hypothesize preoperative butyrate enema will reduce postoperative intestinal complications at short-term and medium/long-term.
|Condition or disease||Intervention/treatment||Phase|
|Hirschsprung's Disease||Drug: butyrate enemas + routine management Other: routine management||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Butyrate Enemas on Postoperative Intestinal Mobility Disorders in Hirschsprung's|
|Estimated Study Start Date :||January 2, 2019|
|Estimated Primary Completion Date :||January 2, 2024|
|Estimated Study Completion Date :||July 2, 2024|
Active Comparator: routine management
Children in the control group receive no additional treatment
Other: routine management
the colonic irrigations
Experimental: EXP GROUP
children receiving butyrate enemas + routine management butyrate enemas every day before Curative surgery
Drug: butyrate enemas + routine management
10ml/kg volume of butyrate enemas in addition to the colonic irrigations
- The time to recovery of bowel function after the curative surgery. A 25% decrease of the time to recovery of bowel function in the experimental group as compared to the control group will be considered as clinically effective. [ Time Frame: 5 YEARS ]
The recovery of bowel function is defined as follows:
- Tolerance of 2 feeds at full ration (as before surgery, breast-feeding or bottle-feeding),
- And passing stools.
The time to recovery of bowel function will be measured in hours from the end of the curative surgery.
- The red carmin total transit time will be measured before the surgery [ Time Frame: 5 YEARS ]After randomisation (and before the first butyrate enema) Before the curative surgery
- The postoperative medium/long-term efficacy of butyrate enemas [ Time Frame: 5 YEARS ]Postoperative functional intestinal obstructive symptoms evaluated at each medical appointment The stool consistency evaluated using the validated 'Amsterdam' infant stool form scale at each medical appointment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660176
|Contact: ANNE DARIEL, MD||+33 491964885||Anne.DARIEL@ap-hm.fr|
|Assistance Publique Des Hopitaux de Marseille|
|Marseille, Paca, France, 13354|
|Study Director:||EMILIE GARRIDO PRADALIE||APHM|