26 completed, 8 unknown, 3 recruiting, 3 terminated. 44 Phase 2, 9 Phase 1, 3 Phase 3.
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 |
|---|---|---|---|---|---|---|
| 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 |
| RIC-NEC Randomized Controlled Trial Remote ischemic conditioning (RIC) + Standard of Care for NEC, Standard of Care for NEC - Necrotizing Enterocolitis | Phase 2 | Completed | The Hospital for Sick Children | 86 | 2023-02-09 | 2026-11-03 |
| Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT) Alanyl-glutamine - Clostridioides Difficile Infection, Clostridium Difficile Infection | Phase 2 | Recruiting | University of Virginia | 260 | 2021-06-01 | 2024-10-26 |
| 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 |
| Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations MAS825, Placebo - NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 17 | 2020-12-18 | 2026-10-09 |
| The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Lactobacillus Reuteri DSM 17938, Placebo - Necrotizing Enterocolitis, Sepsis | Phase 2 | Unknown | Children's Hospital and Institute of Child Health, Multan | 120 | 2020-10-01 | 2020-09-09 |
| Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection Lyophilized fecal microbiota transplant, Lyophilized sterile fecal filtrate - Clostridia Difficile Colitis, Clostridium Difficile Diarrhea | Phase 2 | Completed | University of Alberta | 138 | 2019-03-21 | 2024-06-04 |
| 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 |
| Human Milk Fortification in Extremely Preterm Infants H2MF, Bovine milk-based fortifier - Necrotizing Enterocolitis, Sepsis | Phase 2 / Phase 3 | Active not recruiting | Thomas Abrahamsson, MD, PhD | 229 | 2019-02-01 | 2024-07-23 |
| Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection Vancomycin, Placebo - Recurrent Clostridium Difficile Infection, Clostridium Difficile Infection | Phase 2 | Completed | University of Wisconsin, Madison | 79 | 2018-05-21 | 2025-05-25 |
| Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection LFMT, LSFF - Enterocolitis, Recurrent Clostridium Difficile Infection | Phase 2 | Completed | Dina Kao | 11 | 2018-02-14 | 2020-02-20 |
| Antibiotic "Dysbiosis" in Preterm Infants Antibiotic, Gastric fluid, Breast milk - Enterocolitis, Necrotizing, Bacteremia | Phase 2 | Completed | University of Florida | 98 | 2017-01-16 | 2024-06-05 |
| Heat Killed Probiotics in the Prevention of Necrotizing Enterocolitis Heat Inactivated probiotics, Placebo - Necrotizing Enterocolitis, Enterocolitis, Necrotizing | Phase 2 | Unknown | Shaare Zedek Medical Center | 450 | 2016-06-01 | 2016-06-16 |
| IBP-9414 for the Prevention of Necrotizing Enterocolitis IBP-9414, Placebo - Necrotizing Enterocolitis | Phase 2 | Completed | Infant Bacterial Therapeutics | 120 | 2016-05-27 | 2017-12-29 |
| 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 |
| Stool Transplants to Treat Refractory Clostridium Difficile Colitis fecal microbiota - Clostridium Difficile Colitis | Phase 2 | Recruiting | Duke University | 77 | 2016-04-01 | 2026-08-27 |
| Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection Single-infusion FMT, Vancomycin (before randomization), multiple-infusion FMT - Clostridium Difficile, Pseudomembranous Colitis | Phase 2 | Completed | Catholic University of the Sacred Heart | 58 | 2016-03-01 | 2018-02-09 |
| Prediction of NEC With Urinary iFABP Assessment of urinary iFABP, Administration of enteral feedings - Prematurity, Necrotizing Enterocolitis | Phase 2 | Withdrawn | Loma Linda University | 2014-11-01 | 2015-05-14 | |
| Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile Cultured human intestinal microbiota, Vancomycin, Metronidazole - Clostridium Difficile | Phase 2 | Completed | Per Hellström | 60 | 2014-10-01 | 2019-01-09 |
| 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 |
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Enterocolitis, Necrotizing (28) · Enterocolitis, Pseudomembranous (12) · Premature Birth (9) · Clostridium Infections (6) · Sepsis (6) · Bronchopulmonary Dysplasia (2) · Diarrhea (2) · Ductus Arteriosus, Patent (2) · Dysentery (2) · Intestinal Diseases (2) · Intestinal Perforation (2) · Short Bowel Syndrome (2) · Anemia (1) · Anemia, Aplastic (1)
Digestive System Diseases (43) · Gastroenteritis (43) · Gastrointestinal Diseases (43) · Intestinal Diseases (42) · Infections (22) · Bacterial Infections and Mycoses (14) · Bacterial Infections (13) · Pathological Conditions, Signs and Symptoms (13) · Gram-Positive Bacterial Infections (12) · Pathologic Processes (11) · Female Urogenital Diseases and Pregnancy Complications (9) · Obstetric Labor Complications (9) · Obstetric Labor, Premature (9) · Pregnancy Complications (9)
Vancomycin (4) · Fecal Microbiota Transplantation (2) · Glutamine (2) · Milk, Human (2) · Saline Solution (2) · 4'-galactooligosaccharide (1) · Adjuvants, Pharmaceutic (1) · Ampicillin (1) · Anti-Bacterial Agents (1) · Anti-Inflammatory Agents, Non-Steroidal (1) · Arginine (1) · Biological Evolution (1) · Cefotaxime (1) · Docosahexaenoic Acids (1) · Drainage (1)
Shaare Zedek Medical Center (3) · Ain Shams University (2) · Coordinación de Investigación en Salud, Mexico (2) · Genzyme, a Sanofi Company (2) · Novartis Pharmaceuticals (2) · University of California, San Francisco (2) · University of Florida (2) · Alberta Children's Hospital (1) · Bnai Zion Medical Center (1) · Burnasyan Federal Medical Biophysical Center (1) · Catholic University of the Sacred Heart (1) · Children's Hospital and Institute of Child Health, Multan (1) · China Medical University Hospital (1) · Dina Kao (1) · Duke University (1)
United States (21) · Canada (8) · Israel (4) · Sweden (4) · United Kingdom (3) · Mexico (2) · China (1) · Czechia (1) · Egypt (1) · France (1) · Italy (1) · Japan (1) · Philippines (1) · Puerto Rico (1) · Russia (1)
Cathy Hammerman, MD (3) · Josef Neu, MD (3) · Dina Kao, MD (2) · Agostino Pierro, OBE, MD (1) · Arieh Riskin, MD (1) · Changlian Zhu, PhD (1) · Daisy Evangeline C Garcia, MD (1) · Daniel H Teitelbaum, MD (1) · Danny Benjamin, MD, PhD, MPH (1) · David Sigalet, MD PhD (1) · Edmund LaGamma, MD (1) · GHada A. Saleh, MRCPCH (1) · Gaelle Sadani, MD (1) · Gary M Cox, MD (1)
PMID 10440607, PMID 11171619, PMID 17636753, PMID 18829790, PMID 20980771, PMID 21871249, PMID 22818551, PMID 22955430, PMID 23323867, PMID 23331802, PMID 23453547, PMID 25104129, PMID 25155966, PMID 25534724, PMID 25534727, PMID 25861285, PMID 25927273, PMID 26340878, PMID 27013431, PMID 29851107, PMID 29906796, PMID 30340932, PMID 30850756, PMID 31255386, PMID 31537446, PMID 32771013, PMID 33006765, PMID 33076939, PMID 33479274, PMID 33671220, PMID 33763652, PMID 33923278, PMID 34815288, PMID 37308133, PMID 37474181, PMID 38545091, PMID 39373498, PMID 40601321, PMID 40997843, PMID 9712236
K08HD052885 (1), R21HD088005 (1)