8 completed, 5 unknown, 3 recruiting, 2 terminated. 19 Phase 1, 9 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 19 | Completed 8, Unknown 5, Recruiting 3, Terminated 2, Withdrawn 1 |
| Phase 2 | 9 | Completed 4, Terminated 2, Unknown 2, Recruiting 1 |
Follow Enterocolitis: new trials by email Literature Review of Enterocolitis trials Research Report on Enterocolitis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Gut Permeability and Microbiome in Preterm Infants measurement of intestinal permeability - Prematurity Complications | Phase 1 | Recruiting | University of Maryland, Baltimore | 150 | 2026-09-30 | 2026-10-05 |
| A Study of SER-155 to Treat Diarrhea in People on Immunotherapy SER-155 - Diarrhea, Enterocolitis | Phase 1 | Recruiting | Memorial Sloan Kettering Cancer Center | 15 | 2025-01-24 | 2026-07-28 |
| Phase I Clinical Study of Chondroitin Sulfate for Treatment of NEC Chondroitin sulfate - Necrotizing Enterocolitis, Intestinal Ischemia | Phase 1 | Withdrawn | Indiana University | 2025-01-01 | 2025-10-10 | |
| Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC) ST266 - Necrotizing Enterocolitis | Phase 1 / Phase 2 | Recruiting | Noveome Biotherapeutics, formerly Stemnion | 36 | 2024-08-19 | 2026-04-13 |
| Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis Melatonin 6 MG, Breast Milk - Necrotizing Enterocolitis | Phase 1 / Phase 2 | Completed | Ilocos Training and Regional Medical Center | 100 | 2021-03-01 | 2024-06-20 |
| Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO Inhaled Nitric Oxide, Placebo - Anemia | Phase 1 / Phase 2 | Unknown | New York Medical College | 50 | 2019-02-06 | 2019-04-24 |
| SMOFlipid to Lessen the Severity of Neonatal Cholestasis SMOFlipid - Cholestasis, Jaundice, Obstructive | Phase 1 / Phase 2 | Terminated | University of Florida | 2 | 2016-05-01 | 2017-04-17 |
| Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries SAFE group, placebo group - Necrotizing Enterocolitis | Phase 1 | Unknown | Rania Ali El-Farrash | 40 | 2015-07-01 | 2017-10-05 |
| Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis Peripheral blood stem cell mobilisation and collection, High-dose chemotherapy, Bone marrow derived allogeneic MMSCs infusion - Neutropenic Enterocolitis, Myeloablative Chemotherapy Induced Bone Marrow Aplasia | Phase 1 / Phase 2 | Unknown | Burnasyan Federal Medical Biophysical Center | 16 | 2014-05-01 | 2015-06-10 |
| Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates simulated amniotic fluid 20cc/kg/day enterally, distilled water - Necrotizing Enterocolitis | Phase 1 | Unknown | Rania Ali El-Farrash | 40 | 2014-03-01 | 2015-04-01 |
| STP206 for the Prevention of Necrotizing Enterocolitis (NEC) STP206, Control - Necrotizing Enterocolitis | Phase 1 | Completed | Leadiant Biosciences, Inc. | 103 | 2014-01-30 | 2020-03-24 |
| Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates Docosahexaenoic acid (DHA), Placebo - Necrotizing Enterocolitis | Phase 1 / Phase 2 | Completed | Coordinación de Investigación en Salud, Mexico | 225 | 2012-10-01 | 2021-03-24 |
| Phase I Trial of a Single Dose of CRS3123 CRS3123, Placebo - Clostridium Difficile Colitis | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 40 | 2012-05-22 | 2017-09-25 |
| Safety and Dosing Study of Glucagon-like Peptide 2 (GLP-2) in Infants and Children With Intestinal Failure Glucagon-Like Peptide 2, Glucagon like peptide-2 - Intestinal Failure, Short Bowel Syndrome | Phase 1 / Phase 2 | Terminated | Alberta Children's Hospital | 13 | 2012-01-01 | 2014-12-23 |
| Metronidazole Pharmacokinetics (PK) in Premature Infants Metronidazole - Serious Systemic Infections, Necrotizing Enterocolitis | Phase 1 | Completed | Michael Cohen-Wolkowiez | 24 | 2011-01-01 | 2014-02-06 |
| Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Umbilical Cord Blood Infusion, Intravenous Infusion of Peripheral Blood or its Components - Anemia, Neonatal, Intracranial Hemorrhages | Phase 1 | Unknown | Pomeranian Medical University Szczecin | 40 | 2010-10-01 | 2014-01-31 |
| Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial recombinant human G-CSF, and rhEPO, rh G-CSF, rh EPO - Feeding Intolerance, Necrotizing Enterocolitis | Phase 1 / Phase 2 | Completed | Ain Shams University | 93 | 2010-01-01 | 2011-09-27 |
| Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections meropenem - Necrotizing Enterocolitis, Intra-abdominal Infection | Phase 1 / Phase 2 | Completed | The Emmes Company, LLC | 200 | 2008-06-01 | 2023-04-25 |
| Effects of Delayed Cord Clamping in Very Low Birth Weight Infants delayed cord clamping - Bronchopulmonary Dysplasia, Necrotizing Enterocolitis | Phase 1 | Completed | University of Rhode Island | 72 | 2003-08-01 | 2015-11-30 |
Enterocolitis, Necrotizing (16) · Bronchopulmonary Dysplasia (2) · Premature Birth (2) · Anemia (1) · Anemia, Aplastic (1) · Anemia, Neonatal (1) · Central Nervous System Diseases (1) · Cholestasis (1) · Diarrhea (1) · Enterocolitis, Neutropenic (1) · Enterocolitis, Pseudomembranous (1) · Gastroschisis (1) · Hematologic Diseases (1) · Hodgkin Disease (1)
Digestive System Diseases (19) · Gastroenteritis (19) · Gastrointestinal Diseases (19) · Intestinal Diseases (19) · Pathological Conditions, Signs and Symptoms (6) · Pathologic Processes (5) · Infections (4) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (3) · Hemic and Lymphatic Diseases (3) · Anemia (2) · Female Urogenital Diseases and Pregnancy Complications (2) · Hematologic Diseases (2) · Inflammation (2) · Lung Injury (2)
Chondroitin Sulfates (1) · Docosahexaenoic Acids (1) · Drug Therapy (1) · Fatty Acids, Omega-3 (1) · Glucagon-Like Peptide 2 (1) · Melatonin (1) · Meropenem (1) · Metronidazole (1) · Milk, Human (1) · Parenteral Nutrition (1) · REP 3123 (1) · SMOFlipid (1) · Sunflower Oil (1) · Umbilical Cord Clamping (1)
Rania Ali El-Farrash (2) · Ain Shams University (1) · Alberta Children's Hospital (1) · Burnasyan Federal Medical Biophysical Center (1) · Coordinación de Investigación en Salud, Mexico (1) · Ilocos Training and Regional Medical Center (1) · Indiana University (1) · Leadiant Biosciences, Inc. (1) · Memorial Sloan Kettering Cancer Center (1) · Michael Cohen-Wolkowiez (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · New York Medical College (1) · Noveome Biotherapeutics, formerly Stemnion (1) · Pomeranian Medical University Szczecin (1) · The Emmes Company, LLC (1)
United States (11) · Egypt (2) · Canada (1) · Mexico (1) · Philippines (1) · Poland (1) · Russia (1)
Rania A El-Farrash, MD (2) · Boguslaw Machalinski, MD, PhD, BSc (1) · Daisy Evangeline C Garcia, MD (1) · Danny Benjamin, MD, PhD, MPH (1) · David Faleck, MD (1) · David Sigalet, MD PhD (1) · Edmund LaGamma, MD (1) · Ilya I Eremin, MD, PhD (1) · Jacek Rudnicki, MD, PhD, BSc (1) · Josef Neu, MD (1) · Judith S Mercer, PhD, CNM (1) · Marcela Pasetti, PhD (1) · Mariela Bernabe-Garcia, PhD (1) · Michael Cohen-wolkowiez, MD (1) · Michael S Caplan, MD (1)
PMID 22818551, PMID 22955430, PMID 23587979, PMID 25104129, PMID 25155966, PMID 25927273, PMID 26340878, PMID 26547399, PMID 26643677, PMID 28584140, PMID 29906796, PMID 33671220
R01NR010015 (1)