Clinical trials: Enterocolitis
NEC - Necrotizing Enterocolitis
Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns
This prospective cohort study aims to investigate the impact of early antibiotic exposure on the establishment of gut microbiota and motility in newborns, particularly preterm infants.
- Trial name
- NCT06850896
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Hospital of Jilin University
Feeding Intolerance, Extrauterine Growth Retardation
Feeding Bovine Colostrum to Preterm Infants
Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered as the best for the digestive system followed by donor milk.
- Conditions
- Feeding Intolerance, Extrauterine Growth Retardation, Necrotizing Enterocolitis, Sepsis
- Trial name
- PreColos (NCT02054091)
- Testing
- Bovine colostrum
- Where
- 4 sites in China, Denmark
- Volunteers
- 52 people
- Sponsor
- Per Torp Sangild
Feeding Intolerance in Premature Infants
Glycerin Suppositories Used Prophylactically in Premature Infants (SUPP): a Pilot Randomized Placebo-controlled Trial
All premature babies have problems with feeding and nutrition. Some can develop a life-threatening bowel infection necrotizing enterocolitis.
- Trial name
- NCT02153606
- Testing
- Glycerin Suppository
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- McMaster University
Food Protein-Induced Enterocolitis Syndrome
Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
This is a phase I multicenter clinical trial that aims to find the optimal dose for conducting a novel low-dose, multi-day oral food challenge (OFC) protocol for diagnosing food protein-induced enterocolitis syndrome (FPIES).
- Trial name
- INFINITY (NCT06683521)
- Testing
- Supervised Low-Dose Oral Food Challenge (OFC), At-Home Low-Dose Oral Food Challenge (OFC), Supervised High-Dose Oral Food Challenge (OFC)
- Where
- 2 sites in United States
- Volunteers
- 72 people
- Sponsor
- NYU Langone Health
Necrotizing Enterocolitis
Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries
Amniotic fluid plays a significant role in fetal gut maturation and development. The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel…
- Trial name
- NCT03302338
- Testing
- SAFE group
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Rania Ali El-Farrash
Necrotizing Enterocolitis
Administration of Arginine Supplementation in Preterm Infants
Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker for necrotizing enterocolitis (NEC).
- Trial name
- NCT01336998
- Testing
- arginine
- Where
- Greece
- Volunteers
- 80 people
- Sponsor
- Alexandra Hospital, Athens, Greece
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
Enterocolitis, Necrotizing
Remote Ischemic Conditioning in Necrotizing Enterocolitis
Necrotizing enterocolitis (NEC) affects up to 10% of very preterm infants. NEC mortality is high (30-50 %) and has remained unchanged over the last decades. New treatments are urgently needed.
- Trial name
- NCT03860701
- Testing
- Remote ischemic conditioning
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- The Hospital for Sick Children
Nosocomial Infection, Necrotizing Enterocolitis
Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants
The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.
- Trial name
- NCT01340469
- Testing
- probiotics
- Where
- Thailand
- Volunteers
- 160 people
- Sponsor
- King Chulalongkorn Memorial Hospital
Necrotizing Enterocolitis
The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.
- Trial name
- NCT03700957
- Testing
- Docosahexaenoic Acid
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Enterostomy
Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds ("MUC-FIRE" Trial)
The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of…
- Trial name
- MUC-FIRE (NCT03469609)
- Testing
- mucous fistula refeeding
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Necrotizing Enterocolitis, Intestinal Atresia
Pattern And Outcome Of Neonatal Gastrointestinal Emergencies In Assiut University Children Hospital
This prospective observational study aims to evaluate the pattern, clinical presentation, complications, and short-term outcomes of neonates admitted with gastrointestinal emergencies to the NICU at Assiut University Children…
- Conditions
- Necrotizing Enterocolitis, Intestinal Atresia, Malrotation, Hirschsprung Disease
- Trial name
- NCT07526636
- Volunteers
- 120 people
- Sponsor
- Assiut University
Necrotizing Enterocolitis
SMA Flow Patterns in Neonatal Transfusion
This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates.
- Trial name
- SPARTAN (NCT02347475)
- Testing
- Observational Study
- Where
- Canada
- Volunteers
- 7 people
- Sponsor
- University of Calgary
Infant, Very Low Birth Weight, Infant, Premature
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22…
- Conditions
- Infant, Very Low Birth Weight, Infant, Premature, Ductus Arteriosus, Patent
- Trial name
- TIPP (NCT00009646)
- Testing
- indomethacin
- Where
- 9 sites in United States
- Volunteers
- 1,202 people
- Sponsor
- NICHD Neonatal Research Network
Necrotizing Enterocolitis, Microbial Substitution
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term…
- Trial name
- NCT05272579
- Testing
- Fecal Filtrate Transfer
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Necrotising Enterocolitis Neonatal
Effects of Implementation of a Care Bundle on Rates of NEC and Own Mother's Milk Feeding in the East Midlands
Necrotising enterocolitis (NEC) is a life-threatening gut disease in babies born early. Feeding preterm babies their own mother's milk prevents NEC.
- Trial name
- EMNODN-NEC (NCT05934123)
- Testing
- EMNODN NEC Care Bundle
- Where
- United Kingdom
- Volunteers
- 53,600 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Necrotizing Enterocolitis of Newborn
Necrotizing Enterocolities
Haematological disturbances in neonates with necrotizing enterocolities
- Trial name
- NCT06632041
- Testing
- Complete blood count
- Volunteers
- 70 people
- Sponsor
- Assiut University
Necrotizing Enterocolitis, Digestive System Abnormalities
Brain Manganese Deposition in High Risk Neonates
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN…
- Conditions
- Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392977
- Testing
- remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Vanderbilt University
Hirschsprung Disease, Enterocolitis
Identification Genetic, Immunologic and Microbial Markers of Hirschsprung Associated Enterocolitis in Children With Hirschsprung Disease
To identify demographic, clinical, genetic, immunologic and/or microbial (i.e., fecal stream characterization) risk factors that influence the likelihood of development of the HAEC phenotype in children who carry the diagnosis of…
- Trial name
- HAEC (NCT02193685)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Cedars-Sinai Medical Center
FPIES
Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome
Food Protein Induced Enterocolitis Syndrome (FPIES) is a food allergy characterized by clinical manifestations of varying severity that can be, very rarely, severe to the point of leading to shock.
- Trial name
- DOPAxSEA (NCT06614244)
- Testing
- Oral immunotherapy (OIT), Culprit food elimination diet
- Where
- Italy
- Volunteers
- 168 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS