Clinical trials: Enterocolitis
Necrotizing Enterocolitis, Sepsis
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants…
- Trial name
- NCT01807858
- Testing
- Bifidobacterium lactis, Bifidobacterium lactis plus İnülin, Maltodextrin
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Dr. Sami Ulus Children's Hospital
Human Milk Fortification, Very Low Birth Weight Baby
Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Very Preterm Infants: a Meta-analysis
Research has shown that provision of mother's milk is the optimal way to feed very low birthweight (VLBW) infants. Many infants will require a supplement to mother's milk, pasteurized donor human milk (PDHM) compared to preterm…
- Conditions
- Human Milk Fortification, Very Low Birth Weight Baby, Human Milk Nutrition, Human Milk Feeding
- Trial name
- NCT06870318
- Testing
- No intervention; Observational study
- Where
- 2 sites in Canada, Sweden
- Volunteers
- 355 people
- Sponsor
- The Hospital for Sick Children
Premature Birth, NEC
Prenatal Administration of Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Fetal Rabbit
Infections, particularly on the gastrointestinal tract, has been known to be one of the leading causes of death in preterm infants. This is due to the immaturity of the intestinal epithelial cells.
- Trial name
- NCT04004091
- Testing
- Spermine
- Where
- Indonesia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- dr. Riana Pauline Tamba, SpB(K)BA
Clostridium Difficile Infection
Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
Patients with confirmed C. difficile infection (CDI) who meet eligibility requirements will be invited to participate. All study patients must receive treatment for CDI with metronidazole or vancomycin.
- Trial name
- NCT01077245
- Testing
- MIYA-BM Fine Granules (CBM588)
- Sponsor
- Osel, Inc.
Clostridium Enterocolitis, Pseudomembranous Colitis
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C.
- Trial name
- NCT00106509
- Testing
- tolevamer potassium-sodium (GT267-004)
- Where
- 140 sites in United States, Canada and 1 more
- Volunteers
- 520 people
- Sponsor
- Genzyme, a Sanofi Company
Prematurity, Necrotizing Enterocolitis
Prediction of NEC With Urinary iFABP
During the first four days of life, intestinal fatty acid binding protein (iFABP) is elevated in the urine of premature babies who go on to develop necrotizing enterocolitis (NEC) days to weeks later.
- Trial name
- NCT01805206
- Testing
- Assessment of urinary iFABP, Administration of enteral feedings
- Where
- United States
- Sponsor
- Loma Linda University
Necrotizing Enterocolitis
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
- Trial name
- CoolNEC (NCT01330576)
- Testing
- cooling blanket/mattress, Standard treatment of care at normothermia
- Where
- United Kingdom
- Volunteers
- 13 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Necrotizing Enterocolitis
Qualitative Study of Surgeons With Prospective Patient Follow-up
Necrotising enterocolitis (NEC) is a devastating disease which causes severe bowel inflammation resulting in babies becoming critically unwell.
- Trial name
- NECqual (NCT06032676)
- Where
- United Kingdom
- Volunteers
- 75 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Intraventricular Hemorrhage, Pulmonary Hemorrhage
Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
This study aims to understand the role of extracellular vesicles (EVs) in extremely premature infants, those born before 28 weeks of gestation.
- Conditions
- Intraventricular Hemorrhage, Pulmonary Hemorrhage, Death, ELGAN (22-28SA)
- Trial name
- VEEP (NCT07273643)
- Testing
- Venous Cord blood sample, Arterial cord blood sample
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Montpellier
Clostridium Difficile Infection (CDI)
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes.
- Trial name
- NCT03244644
- Testing
- RBX2660, Open label RBX2660 (only for confirmed CDI recurrence)
- Where
- 66 sites in United States, Canada
- Volunteers
- 320 people
- Sponsor
- Rebiotix Inc.
Transfusions
Impact of Feeding on Pro-Inflammatory Cytokine Response in Neonates Receiving a RBC Transfusion
Prior to a non-urgent blood transfusion, subjects will be randomized to either stopping feeds or continuing feeds. The intervention group will be the placement of a subject in the NPO group.
- Trial name
- NCT01949896
- Testing
- NPO, Control group: continue feedings
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Christiana Care Health Services
Necrotizing Enterocolitis of Newborn
The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis
Study Description The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are: 1.
- Trial name
- NCT05619055
- Testing
- Routine treatment
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zuohui Zhao
Neonatal Disease
Effect of DHA on Proinflammatory Cytokines Including Platelets Activating Factor (PAF) in Preterm Neonates
The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis in preterm/low birth weight neonates.Necrotizing enterocolitis (NEC) is the…
- Trial name
- NCT04746885
- Testing
- DHA
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Ain Shams University
Necrotizing Enterocolitis
Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
- Trial name
- NCT05573113
- Testing
- Bowel Ultrasound, Abdominal radiograph
- Where
- 2 sites in United States
- Volunteers
- 169 people
- Sponsor
- Children's Mercy Hospital Kansas City
Anemia
Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO
The investigators seek to determine whether providing inhaled nitric oxide (iNO; a vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of preterm neonates during and after the subject receives a…
- Trial name
- iNO-TRAGI (NCT02851472)
- Testing
- Inhaled Nitric Oxide
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- New York Medical College
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
Placental Insufficiency, NEC - Necrotizing Enterocolitis
Splanchnic Oxygenation Response to Enteral Feeds in Preterm Infants With Abnormal Antenatal Doppler.
Antenatal absent or reversed end-diastolic flow (AREDF) velocity through the umbilical arteries places preterm infants at significant risk for developing gastrointestinal complications, such as feeding intolerance, necrotizing…
- Conditions
- Placental Insufficiency, NEC - Necrotizing Enterocolitis, Newborn, Premature, Feeding Disorder Neonatal
- Trial name
- AREDF-SO (NCT02971566)
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Hirschsprung Disease
MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis
Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall.
- Trial name
- MICROPRUNG (NCT02857205)
- Testing
- Fecal samples
- Where
- 7 sites in France
- Volunteers
- 118 people
- Sponsor
- Rennes University Hospital
Enterocolitis, Necrotizing, Prematurity
Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC
Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged.
- Conditions
- Enterocolitis, Necrotizing, Prematurity, Gastrointestinal Disease
- Trial name
- NCT04549727
- Testing
- Organoids creation
- Volunteers
- 18 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Prematurity, Anemia
Transfusions and Nitric Oxide Level in Preterm Infants
The purpose of this study is to better understand S-nitrosohemeglobin (SNO-Hb) in transfused blood of extremely preterm infants.
- Conditions
- Prematurity, Anemia, Necrotizing Enterocolitis
- Trial name
- NCT00787124
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Duke University