Disease

Enterocolitis

Late-stage therapeutic developmentEmerging research

MeSHEnterocolitis

Publications

Clinical trials

2023

Latest publication

Latest activity

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Recent clinical, regulatory, research and industry developments relating to this disease.

Severe Immune-Related Enteritis after In Utero Exposure to Pembrolizumab.

Research2023-11-01The New England journal of medicine

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low

Key developments

2 clinical trials expected to report results, the earliest in Q1 2027.

Upcoming Milestones

Major developments

Major trial resultsImportant

Effect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower Gastrointestinal

Results posted2026-03-12

Upcoming trial readoutImportant

A Single-Arm, Open-Label, Phase 1 Study to Assess Safety and Preliminary Efficacy of Cultivated Multi-Strain Live Bacterial Therapeutic SER-155 for First-Line Treatment of Immunotherapy-Related Enterocolitis

Results expected Q1 20272026-07-28

Clinical Milestones5View

Results posted 1

2026-03-12Effect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower GastrointestinalResults posted

Results expected 2

Recently completed 1

2026-06-30Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 gPrimary completion

Other updates 1

2029-03-01A Randomized, Controlled, Double-Blind Phase I Clinical Study of Chondroitin Sulfate Supplementation for Treatment of Necrotizing EnterocolitisWithdrawn

Activity timeline5

2029-03-01ClinicalA Randomized, Controlled, Double-Blind Phase I Clinical Study of Chondroitin Sulfate Supplementation for Treatment of Necrotizing EnterocolitisWithdrawn
2026-07-28ClinicalA Single-Arm, Open-Label, Phase 1 Study to Assess Safety and Preliminary Efficacy of Cultivated Multi-Strain Live Bacterial Therapeutic SER-155 for First-Line Treatment of Immunotherapy-Related EnterocolitisResults expected Q1 2027
2026-06-30ClinicalEfficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 gPrimary completion
2026-04-13ClinicalRandomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)Results expected Q2 2029
2026-03-12ClinicalEffect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower GastrointestinalResults posted

Clinical trials

17 sponsors · 0 new · 0 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme

All trials

Active

Late-stage

Completed

Late-stage studies

A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study

Phase 3 · Active, not recruiting · Infant Bacterial Therapeutics

Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 g

Phase 4 · Active, not recruiting · Coordinación de Investigación en Salud, Mexico

Effect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower Gastrointestinal

Phase 4 · Completed · Rockefeller University

Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants

Phase 4 · Completed · Ain Shams University

A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)

Phase 2/3 · Completed · University of Alberta

The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants

Phase 3 · Completed · Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Recruiting

Phase 1 · Recruiting · Memorial Sloan Kettering Cancer Center

Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)

Phase 1/2 · Recruiting · Noveome Biotherapeutics, formerly Stemnion

Recently completed

Evaluation of the Clinical and Growth-related Effects of Probiotics in Preterm Infants: A Randomized, Placebo Controlled Clinical Trial.

Phase 4 · Completed · Madiha, MPhil

Effect of Antibiotics on Submucosal Enteric Neurons and Glia in the Lower Gastrointestinal

Phase 4 · Completed · Rockefeller University

Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis

Phase 3 · Completed · Tanta University

Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants

Phase 4 · Completed · Ain Shams University

A Prospective, Multi-center, Randomized Trial of Fecal Microbiota Transplantation (FMT) Delivered by Capsule vs Colonoscopy in the Management of Recurrent Clostridium Difficile Infection (CDI)

Phase 2/3 · Completed · University of Alberta

The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants

Phase 3 · Completed · Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Research activity

1 paper

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Most influential

Severe Immune-Related Enteritis after In Utero Exposure to Pembrolizumab.

The New England journal of medicine · 2023 · 21 cites

Recent publications

Severe Immune-Related Enteritis after In Utero Exposure to Pembrolizumab.

The New England journal of medicine · 2023 · 21 cites

Major themes3

Gastroenteritis1
Immune Checkpoint Inhibitors1
Neoplasms1

Leading journals1

The New England journal of medicine1

Leading researchers8

Amant F1
Baarslag MA1
Beijnen JH1
Borgers JSW1
Buitelaar PLM1
de Groot JWB1
Gierenz N1
Haanen JBAG1

Affiliations (unnormalised)1

Amalia Children's Hospital1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Inflammation of the MUCOSA of both the SMALL INTESTINE and the LARGE INTESTINE. Etiology includes ISCHEMIA, infections, allergic, and immune responses.

Identifiers

MeSHEnterocolitis

References & data sources

Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
Related entities are derived from literature co-mention (studied together) — associative, not causal.