Clinical trials: Enterocolitis
Necrotizing Enterocolitis, Time to Full Enteral Nutrition
Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants
Optimizing enteral nutrition (EN) is challenging in extremely preterm infants due to feeding intolerance that relates to the functional gastrointestinal immaturity.
- Trial name
- NCT03631979
- Testing
- Intestinal lavage with normal saline
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- Uppsala County Council, Sweden
Colostomy, Hirschsprung Disease - Pull Through
Bowel Preparation in Elective Pediatric Colorectal Surgery
Infections after elective intestinal surgery remain a significant burden for patients and for the health care system. The cost of treating a single surgical site infection is estimated at approximately $27,000.
- Conditions
- Colostomy, Hirschsprung Disease - Pull Through, Necrotizing Enterocolitis, Inflammatory Bowel Diseases
- Trial name
- NCT03593252
- Testing
- Senna, Sodium Picosulfate, Magnesium Oxide and Citric Acid, Metronidazole Oral
- Volunteers
- 81 people
- Sponsor
- McMaster University
Necrotising Enterocolitis
Predictors of Neonatal Necrotizing Enterocolitis
To assess the value of peripheral blood neutrophil to lymphocyte ratio (NLR), serum levels of γ-Glutamyl transferase (GGT), total serum bilirubin and serum calcium (Ca2+) concentrations for early diagnosis and prediction of NEC…
- Trial name
- NCT04277533
- Testing
- Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR)
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Ain Shams University
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born…
- Trial name
- NCT07045844
- Testing
- Pasteurized Donor Milk for Insufficient Breastfeeding, Preterm Formula for Insufficient Breastfeeding, Routine fortification
- Where
- 24 sites in China
- Volunteers
- 2,324 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Time for Achievement of Full Feeds
Early Versus Late Initiation of Feeding in Preterm Newborns With Prenatal AREDF in Umbilical Artery
This research is being conducted in preterm newborns with 'in utero' growth restriction due to inadequate blood flow from the mother to the baby.
- Trial name
- AREDF (NCT01759615)
- Testing
- Early Enteral feeding, Late enteral feeding
- Volunteers
- 60 people
- Sponsor
- Lady Hardinge Medical College
Clostridium Infections, Clostridioides Difficile
Bezlotoxumab Versus FMT for Multiple Recurrent CDI
The objective of this trial is to investigate whether a treatment strategy offering bezlotoxumab before FMT in patients suffering from multiple recurrent CDI results in equal efficacy compared with a treatment strategy with…
- Conditions
- Clostridium Infections, Clostridioides Difficile, Enterocolitis, Pseudomembranous
- Trial name
- BSTEP (NCT05077085)
- Testing
- Bezlotoxumab, Fecal Microbiota Transplantation (FMT), Vancomycin oral
- Where
- 4 sites in Netherlands
- Sponsor
- Leiden University Medical Center
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Clostridium Difficile Infection, Infection
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of…
- Conditions
- Clostridium Difficile Infection, Infection, Communicable Diseases
- Trial name
- CD3-OLS (NCT03931941)
- Testing
- RBX2660
- Where
- 51 sites in United States, Canada
- Volunteers
- 793 people
- Sponsor
- Rebiotix Inc.
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
Preterm Neonates and Feeding Intolerance, Necrotizing Enterocolitis
Effect of Oral N-Acetyl Cysteine in Prevention of Necrotizing Enterocolitis in Preterm Neonates With Feeding Intolerance
necrotizing enterocolitis is a dangerous disease that may be fatal especially in preterm neonates, the early features of the disease are symptoms of feeding intolerance and interruption of the baby's feeding plan , so…
- Conditions
- Preterm Neonates and Feeding Intolerance, Necrotizing Enterocolitis, Oral N-acetyl Cysteine
- Trial name
- Oral NAC (NCT06202911)
- Testing
- oral n-acetyl cysteine
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Ain Shams University
Necrotizing Enterocolitis, Very Low Birth Weight Infants
Splanchnic Oxygenation After the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance.
Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding…
- Trial name
- NIRS-SO (NCT02383264)
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Anemia, Necrotizing Enterocolitis
RBC Irradiation, Anemia and Gut Injury
The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a…
- Trial name
- RBC-mNIRS (NCT02741648)
- Testing
- Near Infrared Spectroscopy, Non-invasive Image-based Anemia Assessment
- Where
- 3 sites in United States
- Volunteers
- 324 people
- Sponsor
- Emory University
Infection, Enterocolitis, Necrotizing
Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in immune factors which may provide…
- Conditions
- Infection, Enterocolitis, Necrotizing, Ventilator-associated Pneumonia
- Trial name
- NCT02116699
- Testing
- oropharyngeal mother's milk, oropharyngeal sterile water
- Where
- 5 sites in United States
- Volunteers
- 260 people
- Sponsor
- Endeavor Health
Feeding Intolerance, Necrotizing Enterocolitis
Bovine Colostrum as a Human Milk Fortifier for Preterm Infants
Very preterm infants (<32 weeks gestation) show the immaturity of organs and have high nutrient requirements for growth and development.
- Conditions
- Feeding Intolerance, Necrotizing Enterocolitis, Postnatal Growth, Late-Onset Neonatal Sepsis
- Trial name
- FortiColos-Ⅱ (NCT03822104)
- Testing
- Bovine Colostrum, FM85
- Where
- 2 sites in China
- Volunteers
- 139 people
- Sponsor
- Per Torp Sangild
Neutropenic Enterocolitis
Profile Fecal Analysis of Neutropenic Enterocolitis
A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for…
- Trial name
- PROFANE (NCT04438278)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Necrotising Enterocolitis Neonatal
Neonatal Laparotomy - A Trial Investigating the Impact of Location of Surgery
This is a pilot randomised trial allocating neonates requiring emergency laparotomy to surgery either on the neonatal unit or in the operating theatre.
- Trial name
- NeoLap (NCT07754435)
- Testing
- IN theatre, ON unit
- Volunteers
- 15 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Necrotizing Enterocolitis (NEC)
Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants
The goal of this clinical trial is to evaluate whether multi-strain probiotics of lactobacillus and bifidobacterium can prevent necrotizing enterocolitis (NEC) in preterm infants born at less than 32 weeks of gestation.
- Trial name
- NCT06810154
- Testing
- Multi-strain probiotics
- Where
- 4 sites in Canada
- Volunteers
- 2,170 people
- Sponsor
- University of Calgary
Gastric Residuals Assessment, Prematurity
Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding?
The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications…
- Conditions
- Gastric Residuals Assessment, Prematurity, Sepsis Newborn, Necrotizing Enterocolitis of Newborn
- Trial name
- GRASS (NCT03111329)
- Testing
- No aspiration of gastric residuals
- Where
- 2 sites in Czechia, Ireland
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic
Sepsis, Necrotizing Enterocolitis
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
Circulating markers to diagnose complications (sepsis, necrotizing enterocolitis) in preterm infants are often inaccurate, partly due to the lack of comprehensive studies with temporal evaluation from birth until a disease onset.
- Conditions
- Sepsis, Necrotizing Enterocolitis, Chorioamnionitis, Feeding Intolerance
- Trial name
- NEOINFLAM (NCT03320785)
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Per Torp Sangild
Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy
Non-Immunoglobulin E-mediated Food Allergies in Children
Non-IgE-mediated gastrointestinal food allergies (non-IgE-GIFA) are an evolving web of clinical conditions characterized by subacute and/or chronic symptoms and include food protein-induced enterocolitis syndrome (FPIES), food…
- Conditions
- Non IgE Mediated Food Allergy, Food Protein-Induced Enteropathy, Food Protein-Induced Proctocolitis, Food Protein-Induced Enterocolitis Syndrome
- Trial name
- NIGEFA (NCT04462978)
- Testing
- Non IgE-mediated food allergy
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Federico II University