Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01536483
Status:
TERMINATED
Last Update Posted:
2016-05-11
First Post:
2012-02-16
Brief Title:
Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms 1250 Grams
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms 1250 Grams Clinical Trial Prospective Monocentric Randomized in Double-blinded
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The second intermediary analysis showed no significant difference between both arms
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEOTRANS
Brief Summary:
Clinical management of very low birth weight newborns VLBW 1250g consists in several challenges to adapt immature physiological systems to extrauterine life Advances in neonatal medicine for pulmonary andor neurological andor cardiovascular diseases have significantly improved outcomes of these children However the gastro-intestinal GI tract remains a major cause of morbidity due to
1 the immaturity of GI functions prolonged ileus bacterial overgrowth and translocation
2 the complication of GI tract immaturity intestinal perforation and enterocolitis necrotizing
3 the need of a prolonged parenteral nutrition and its complications central venous catheter infections sepsis electrolyte disturbances but without generate a high proof level on this targeted population 1250g
The GI functions are progressively acquired during development and are largely sensitive to the environment especially the intestinal luminal content Indeed probiotics and prebiotics have shown beneficial effects upon GI functions of newborns One of the metabolite of the gut flora potentially involved is the butyrate Butyrate is a short chain fatty acid produced in the colon by the microbiota carbo-hydrates degradation The colonic amount of butyrate increases gradually after birth The beneficial effects of butyrate are related to its properties upon the epithelial barrier anti-inflammatory antioxidant barrier repair and upon the enteric nervous system network of neurons and glial cells that regulate GI functions and in particular colonic motility
To date there is no clinical consensus to manage digestive disorders of VLBW Several clinical studies have assessed the effects of prokinetic drugs dietary supplements probiotics prebiotics but without generate a high proof level on this targeted population In this context a recent study of our Research Unit INSERM-CIC Mère-Enfant 004 has shown benefit effects of oral probiotics supplementation in children with birth weight greater than 1000g but not in extreme preterms with birth weight less than 1000g
The main hypothesis to explain theses results lies in the intensive use of antibiotic and feeding interruption frequency in this targeted population which induce disturbances in the composition of the gut lumen in particular the flora
Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate a clinical efficiency upon the colonic transit underlying by mechanical and osmotic mechanisms
Here the investigators propose to evaluate the clinical efficiency of butyrate enemas by a prospective randomized clinical trial blinded design
The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the nutritional management of extreme preterm less than 1250 grams by facilitating the development of colic motility and clinical nutrition tolerance
1 the immaturity of GI functions prolonged ileus bacterial overgrowth and translocation
2 the complication of GI tract immaturity intestinal perforation and enterocolitis necrotizing
3 the need of a prolonged parenteral nutrition and its complications central venous catheter infections sepsis electrolyte disturbances but without generate a high proof level on this targeted population 1250g
The GI functions are progressively acquired during development and are largely sensitive to the environment especially the intestinal luminal content Indeed probiotics and prebiotics have shown beneficial effects upon GI functions of newborns One of the metabolite of the gut flora potentially involved is the butyrate Butyrate is a short chain fatty acid produced in the colon by the microbiota carbo-hydrates degradation The colonic amount of butyrate increases gradually after birth The beneficial effects of butyrate are related to its properties upon the epithelial barrier anti-inflammatory antioxidant barrier repair and upon the enteric nervous system network of neurons and glial cells that regulate GI functions and in particular colonic motility
To date there is no clinical consensus to manage digestive disorders of VLBW Several clinical studies have assessed the effects of prokinetic drugs dietary supplements probiotics prebiotics but without generate a high proof level on this targeted population In this context a recent study of our Research Unit INSERM-CIC Mère-Enfant 004 has shown benefit effects of oral probiotics supplementation in children with birth weight greater than 1000g but not in extreme preterms with birth weight less than 1000g
The main hypothesis to explain theses results lies in the intensive use of antibiotic and feeding interruption frequency in this targeted population which induce disturbances in the composition of the gut lumen in particular the flora
Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate a clinical efficiency upon the colonic transit underlying by mechanical and osmotic mechanisms
Here the investigators propose to evaluate the clinical efficiency of butyrate enemas by a prospective randomized clinical trial blinded design
The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the nutritional management of extreme preterm less than 1250 grams by facilitating the development of colic motility and clinical nutrition tolerance
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None