16 completed, 4 unknown, 2 active not recruiting, 2 terminated. 26 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 26 | Completed 16, Unknown 4, Active not recruiting 2, Terminated 2, Not yet recruiting 1, Recruiting 1 |
| Phase 2 | 3 | Active not recruiting 1, Completed 1, Unknown 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 |
|---|---|---|---|---|---|---|
| Vancomycin Taper to Prevent Recurrent Clostridioides Difficile Fidaxomicin, Vancomycin capsule - Clostridia Difficile Colitis | Phase 3 | Recruiting | McGill University Health Centre/Research Institute of the McGill University Health Centre | 500 | 2026-04-24 | 2026-09-23 |
| Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants Multi-strain probiotics - Necrotizing Enterocolitis (NEC) | Phase 3 | Not yet recruiting | University of Calgary | 2170 | 2025-06-01 | 2025-02-05 |
| A Multi-center, Single-arm Trial Exploring the Safety and Clinical Effectiveness of RBX2660 Administered by Colonoscopy to Adults With Recurrent Clostridioides Difficile Infection RBX2660 - Clostridium Difficile Infection Recurrence | Phase 3 | Completed | Ferring Pharmaceuticals | 41 | 2023-04-21 | 2026-04-24 |
| Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis Pentoxifylline, Probiotic Formula - Necrotizing Enterocolitis | Phase 3 | Completed | Tanta University | 75 | 2022-06-30 | 2024-05-20 |
| Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion Continuous amnioinfusion with Amnion Flush Solution through the intraamniotic catheter - Bronchopulmonary Dysplasia, Necrotizing Enterocolitis | Phase 3 | Unknown | Martin-Luther-Universität Halle-Wittenberg | 68 | 2021-01-01 | 2021-01-12 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) RBX2660 - Clostridium Difficile Infection, Infection | Phase 3 | Completed | Rebiotix Inc. | 793 | 2019-07-30 | 2024-08-07 |
| IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study IBP-9414, Placebo - Necrotizing Enterocolitis | Phase 3 | Active not recruiting | Infant Bacterial Therapeutics | 2158 | 2019-07-04 | 2024-04-12 |
| 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 |
| Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies. bLF (Bovine lactoferrin), Glucon-D 99.4% (Placebo) - Neonatal Sepsis, Necrotizing Enterocolitis | Phase 3 | Unknown | Aga Khan University | 300 | 2018-05-01 | 2020-04-09 |
| Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3) RBX2660, Placebo, Open label RBX2660 (only for confirmed CDI recurrence) - Clostridium Difficile Infection (CDI) | Phase 3 | Completed | Rebiotix Inc. | 320 | 2017-07-31 | 2024-07-10 |
| The Efficacy of Symbiotic on Cytokines distilled water, symbiotic - Necrotising Enterocolitis | Phase 3 | Completed | Zeynep Kamil Maternity and Pediatric Research and Training Hospital | 70 | 2013-07-01 | 2014-08-08 |
| Role of Probiotics for Prevention of NEC in Preterm VLBW Infants Probiotics, Breast milk - Necrotizing Enterocolitis | Phase 3 | Completed | Sylhet M.A.G.Osmani Medical College | 60 | 2012-07-01 | 2016-01-08 |
| Lactobacillus Reuteri for Prevention of Necrotizing Enterocolitis in Very Low-birth Weight Infants Lactobacillus reuteri, Placebo - Necrotizing Enterocolitis, Very Low Birth Weight Infants | Phase 3 | Completed | Zekai Tahir Burak Women's Health Research and Education Hospital | 400 | 2012-02-01 | 2013-05-13 |
| Probiotics in the Management of Necrotizing Enterocolitis in HIV-exposed Premature Infants Probiotic, Placebo - Necrotizing Enterocolitis | Phase 3 | Completed | University of Stellenbosch | 184 | 2011-07-01 | 2013-07-22 |
| Effect of L-arginine and Glutamine on Preterm Glutamine, l-arginine - NEC, Sepsis | Phase 2 / Phase 3 | Completed | Ain Shams University | 75 | 2011-05-01 | 2014-04-15 |
| Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants Saccharomyces boulardii, Placebo - Necrotizing Enterocolitis, Very Low Birth Weight Infants | Phase 3 | Unknown | Zekai Tahir Burak Women's Health Research and Education Hospital | 220 | 2011-02-01 | 2011-08-08 |
| Prophylactic Probiotics in Premature Infants Lactobacillus reuteri, Placebo - Death, Nosocomial Infection | Phase 3 | Terminated | Colombian Neonatal Research Network | 751 | 2008-08-01 | 2011-06-22 |
| A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea GT267-004 (tolevamer potassium sodium) - Enterocolitis, Pseudomembranous, Diarrhea | Phase 3 | Terminated | Genzyme, a Sanofi Company | 65 | 2007-04-01 | 2015-03-19 |
| Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis Vitamin A - Sepsis, Necrotizing Enterocolitis | Phase 3 | Completed | Johns Hopkins University | 424 | 2006-12-01 | 2013-09-25 |
| Cysteine Supplementation in Critically Ill Neonates Parenteral cysteine-HCl supplementation, Placebo - added premasol - Sepsis, Bronchopulmonary Dysplasia | Phase 2 / Phase 3 | Unknown | University of California, Los Angeles | 108 | 2006-09-01 | 2010-02-26 |
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Enterocolitis, Necrotizing (17) · Enterocolitis, Pseudomembranous (9) · Diarrhea (5) · Sepsis (4) · Bronchopulmonary Dysplasia (2) · Clostridium Infections (2) · Cross Infection (2) · Premature Birth (2) · Acquired Immunodeficiency Syndrome (1) · Communicable Diseases (1) · Death (1) · Ductus Arteriosus, Patent (1) · Dysentery (1) · Infections (1) · Intracranial Hemorrhages (1)
Digestive System Diseases (26) · Gastroenteritis (26) · Gastrointestinal Diseases (26) · Intestinal Diseases (26) · Infections (16) · Pathological Conditions, Signs and Symptoms (13) · Bacterial Infections (9) · Bacterial Infections and Mycoses (9) · Gram-Positive Bacterial Infections (9) · Pathologic Processes (9) · Clostridium Infections (7) · Inflammation (5) · Signs and Symptoms (5) · Signs and Symptoms, Digestive (5)
Probiotics (3) · Arginine (1) · Fidaxomicin (1) · Glutamine (1) · Indomethacin (1) · Metronidazole (1) · Milk, Human (1) · Pentoxifylline (1) · Rifampin (1) · Saline Solution (1) · Single Person (1) · Vancomycin (1) · Vitamin A (1) · amino-acid, glucose, and electrolyte solution (1) · nitazoxanide (1)
Genzyme, a Sanofi Company (3) · Rebiotix Inc. (2) · Zekai Tahir Burak Women's Health Research and Education Hospital (2) · Aga Khan University (1) · Ain Shams University (1) · Colombian Neonatal Research Network (1) · Daniel M. Musher MD (1) · Ferring Pharmaceuticals (1) · Infant Bacterial Therapeutics (1) · Johns Hopkins University (1) · King Chulalongkorn Memorial Hospital (1) · Martin-Luther-Universität Halle-Wittenberg (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · McMaster University (1) · NICHD Neonatal Research Network (1)
United States (9) · Canada (6) · Turkey (Türkiye) (3) · Egypt (2) · France (2) · Germany (2) · Spain (2) · Sweden (2) · United Kingdom (2) · Australia (1) · Austria (1) · Bangladesh (1) · Belgium (1) · Bulgaria (1) · Colombia (1)
Teena Chopra, M.D., M.P.H. (2) · Almas Aamir, MSC (1) · Avroy A. Fanaroff, MD (1) · Barbara J. Stoll, MD (1) · Barbara Schmidt, MD (1) · Charles R. Bauer, MD (1) · Christian L Coles, PhD (1) · Christine H Lee, MD (1) · Daniel M Musher, M.D. (1) · David K. Stevenson, MD (1) · Emily McDonald, MD MSc (1) · Evette van Niekerk, M Dietetics (1) · Fahri Ovali (1) · GHada A. Saleh, MRCPCH (1)
PMID 42286373, PMID 24799326, PMID 41245385, PMID 11430325, PMID 12622582, PMID 16647401, PMID 16769377, PMID 17188612, PMID 17307535, PMID 17636753, PMID 18245398, PMID 19117897, PMID 21727276, PMID 23071204, PMID 24309022, PMID 24919691, PMID 25861285, PMID 28710882, PMID 33006765, PMID 33058137, PMID 33704071, PMID 34815288, PMID 36143388, PMID 36287379, PMID 37493095, PMID 37564743, PMID 38236515, PMID 38545091, PMID 38556499, PMID 39172632, PMID 39180326, PMID 40177588, PMID 40321366, PMID 40348496, PMID 40552763, PMID 40672762, PMID 40784972, PMID 41115624, PMID 41230019, PMID 41647268, PMID 41653256, PMID 42840322
K01DK075478 (1), K08HD052885 (1), M01RR000070 (1), M01RR000997 (1), U10HD021364 (1), U10HD021373 (1), U10HD021385 (1), U10HD021397 (1), U10HD027851 (1), U10HD027880 (1), U10HD027881 (1), U10HD027904 (1), U10HD034216 (1)