Pouchitis

Summary

Pouchitis (MONDO:0005312) is a disease and 45 clinical trials. Top therapeutic interventions include vedolizumab, ciprofloxacin, and clotrimazole. A subtype of small intestine disorder — broader associated-gene and molecular evidence is on the parent page (see Disease family below).

At a glance

• Prevalence: 1-5 / 10 000 (Europe) [Orphanet-validated]
• Phenotypes (HPO): 10
• Clinical trials: 45

Clinical features

Epidemiology

Prevalence records

1 prevalence record(s), Orphanet:

Type	Class	Value	Geography	Validation
Point prevalence	1-5 / 10 000	22	Europe	Validated

Signs & symptoms

Clinical features (HPO)

10 HPO clinical features (Orphanet curated; top 10 by frequency):

HPO ID	Term	Frequency
HP:0001945	Fever	Frequent (30-79%)
HP:0002014	Diarrhea	Frequent (30-79%)
HP:0002027	Abdominal pain	Frequent (30-79%)
HP:0002573	Hematochezia	Frequent (30-79%)
HP:0002607	Bowel incontinence	Frequent (30-79%)
HP:0012701	Bowel urgency	Frequent (30-79%)
HP:0012702	Tenesmus	Frequent (30-79%)
HP:0032155	Abdominal cramps	Frequent (30-79%)
HP:0032168	Clostridium difficile colitis	Frequent (30-79%)
HP:0500005	Anal pain	Frequent (30-79%)

Identifiers

Disease identifiers

Field	Value
Canonical name	pouchitis
Mondo ID	MONDO:0005312
EFO	EFO:0003921
MeSH	D019449
Orphanet	217067
ICD-10-CM	K91.850
UMLS	C0376620
MedGen	138232
GARD	0020510
Anatomy (UBERON)	UBERON:0002116
Is cancer (heuristic)	no

Disease family

Classification path: disease › human disease › disease by body system or component › digestive system disorder › intestinal disorder › small intestine disorder › pouchitis

Related subtypes (9): small intestine diverticulitis, duodenal disorder, small intestine neoplasm, celiac disease, atresia of small intestine, congenital short bowel syndrome, enteritis, small intestinal bacterial overgrowth, small intestine duplication

Genetics & variants

GWAS landscape

No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.

Variant details and genetic-evidence tiers

No tiered GWAS variants or ClinVar records for this disease.

Genes & proteins

No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).

Function

No pathway enrichment — requires an associated-gene cohort.

Therapeutics

Drugs indicated for this disease

0 approved, 3 in late-stage (phase 3) trials. Disease-direct ChEMBL indications, not inferred from the associated-gene cohort below.

Drug	Development status
Alicaforsen	Phase 3 (in late-stage trials)
Ustekinumab	Phase 3 (in late-stage trials)
Vedolizumab	Phase 3 (in late-stage trials)

Earlier-phase candidates (phase 2, investigational — efficacy not yet established): Charcoal, Activated, Liraglutide, Tofacitinib.

Clinical trials & evidence

Clinical trials

Clinical trials: 45.

Phase distribution (across all retrieved trials)

Phase	Trials
Not specified	16
PHASE2	10
PHASE3	6
PHASE4	5
PHASE1/PHASE2	3
PHASE1	2
EARLY_PHASE1	2
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06312683	PHASE4	RECRUITING	Rifaximin for the Secondary Prevention of Recurrent Pouchitis
NCT06864403	PHASE4	RECRUITING	Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
NCT06916390	PHASE4	RECRUITING	GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis
NCT07240649	PHASE4	NOT_YET_RECRUITING	Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications
NCT02790138	PHASE4	COMPLETED	A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis
NCT03524352	PHASE3	ACTIVE_NOT_RECRUITING	the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
NCT06443502	PHASE3	RECRUITING	A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis
NCT00293553	PHASE3	COMPLETED	Clinical Approaches to Ileal Pouch Dysfunction
NCT01670240	PHASE3	COMPLETED	Adalimumab in the Treatment of Chronic Pouchitis
NCT02525523	PHASE3	COMPLETED	Efficacy of Alicaforsen in Pouchitis Patients Who Have Failed to Respond to at Least One Course of Antibiotics
NCT03724175	PHASE2/PHASE3	TERMINATED	The Role of Secondary Bile Acids in Intestinal Inflammation
NCT04089345	PHASE3	COMPLETED	Stelara fOr ChRonic AntibioTic rEfractory pouchitiS
NCT03545386	PHASE2	RECRUITING	Fecal Microbiota Transplantation for Pouchitis
NCT07226050	PHASE2	RECRUITING	CLF065 for Chronic Pouchitis
NCT07486921	PHASE2	NOT_YET_RECRUITING	Etrasimod as Prevention of Pouchitis
NCT00061282	PHASE1/PHASE2	TERMINATED	Clotrimazole Enemas for Pouchitis in Children and Adults
NCT00583076	PHASE2	COMPLETED	Safety and Efficacy of AST-120 in the Treatment of Pouchitis
NCT00583531	PHASE2	TERMINATED	Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
NCT02201186	PHASE2	COMPLETED	To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis
NCT02782325	PHASE1/PHASE2	TERMINATED	Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)
NCT03378921	PHASE2	COMPLETED	Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis
NCT04580277	PHASE2	TERMINATED	Tofacitinib For Treatment Of Chronic Pouchitis
NCT04741087	PHASE2	COMPLETED	Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis
NCT04763564	PHASE2	TERMINATED	Efficacy of Liraglutide Therapy in Patients With IPAA
NCT04979832	PHASE1/PHASE2	UNKNOWN	GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery
NCT02203955	PHASE1	COMPLETED	Study of Sc-FOS for Pouchitis Prevention
NCT05578508	PHASE1	WITHDRAWN	Stem Cells for the Treatment of Pouchitis
NCT05829109	EARLY_PHASE1	RECRUITING	Fecal Microbiota Transplant for Patients With Chronic Pouchitis
NCT02428361	EARLY_PHASE1	COMPLETED	Fecal Microbiota Transplant (FMT) for Pouchitis
NCT04912999	Not specified	RECRUITING	Inflammatory Bowel Diseases Remission Registry
NCT06861140	Not specified	NOT_YET_RECRUITING	Exploring the Influence of Trptophan on the Treatment of Pouchitis
NCT01202396	Not specified	UNKNOWN	The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis
NCT01798953	Not specified	COMPLETED	Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis
NCT02828410	Not specified	COMPLETED	Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA
NCT03136419	Not specified	UNKNOWN	Microbiota and Immune microEnvironment in Pouchitis
NCT03526796	Not specified	UNKNOWN	Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis
NCT03538366	Not specified	COMPLETED	Fecal Microbiota Transplantation for Chronic Pouchitis
NCT04100291	Not specified	TERMINATED	Faecal Microbiota Transplantation in the Treatment of Chronic Pouchitis
NCT04327219	Not specified	UNKNOWN	Prospective Dietary Therapy Using Crohn’s Disease Exclusion Diet for Ileal Pouch Anal Anastomosis Patients
NCT04640155	Not specified	WITHDRAWN	Treating Chronic Pouchitis With a Low FODMAP Diet

Drugs tested across these trials (top 30)

Molecule	Max phase	Trials referencing
VEDOLIZUMAB	4	2
CIPROFLOXACIN	4	1
CLOTRIMAZOLE	4	1
ETRASIMOD	4	1
GUSELKUMAB	4	1
OXYGEN	4	1
TOFACITINIB	4	1
TRYPTOPHAN	4	1
USTEKINUMAB	4	1
CHARCOAL, ACTIVATED	3	2
ALICAFORSEN	3	1
MALTODEXTRIN	3	1
ALICAFORSEN SODIUM	-1	1