Pouchitis

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8Active trials25Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Pouchitis is an inflammatory condition affecting the ileal pouch (also called a J-pouch or ileal pouch-anal anastomosis, IPAA) that is surgically created after total proctocolectomy, most commonly performed in patients with ulcerative colitis or familial adenomatous polyposis. The ileal pouch serves as an internal reservoir for stool after the colon and rectum have been removed. Pouchitis represents the most common long-term complication following this surgery, characterized by inflammation of the mucosal lining of the pouch. The condition primarily affects the gastrointestinal system, with key symptoms including increased stool frequency, watery or bloody diarrhea, urgency, fecal incontinence, abdominal cramping, pelvic discomfort, and occasionally fever and malaise. Some patients may also experience extraintestinal manifestations such as joint pain or skin lesions. Pouchitis can present as acute (responding to a short course of treatment), relapsing (recurrent episodes), or chronic (persistent symptoms lasting more than four weeks despite standard therapy). Diagnosis is established through a combination of clinical symptoms, endoscopic findings (such as mucosal edema, ulceration, and erythema), and histological evidence of acute inflammation. The first-line treatment for acute pouchitis is antibiotic therapy, most commonly with metronidazole or ciprofloxacin. For chronic or refractory pouchitis, treatment options include prolonged or combination antibiotic courses, probiotics (such as the VSL#3 formulation for maintenance of remission), immunomodulators, corticosteroids (topical or systemic), and biologic therapies such as anti-TNF agents. The exact etiology remains unclear but is thought to involve a multifactorial interplay of genetic susceptibility, gut microbiome dysbiosis, and immune dysregulation.

Clinical phenotype terms— hover any for plain English:

HematocheziaHP:0002573Bowel urgencyHP:0012701TenesmusHP:0012702Abdominal crampsHP:0032155Clostridium difficile colitisHP:0032168Anal painHP:0500005
Inheritance

Multifactorial

Caused by a mix of several genes and environmental factors

Age of Onset

Adult

Begins in adulthood (age 18 or older)

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
Mar 2026CLF065 for Chronic Pouchitis

Calibr, a division of Scripps Research — PHASE2

TrialRECRUITING
Mar 2026Etrasimod as Prevention of Pouchitis

Maia Kayal — PHASE2

TrialNOT YET RECRUITING
Sep 2025GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

Universitaire Ziekenhuizen KU Leuven — PHASE4

TrialNOT YET RECRUITING
Aug 2025Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

University of North Carolina, Chapel Hill — PHASE4

TrialRECRUITING
Apr 2025Exploring the Influence of Trptophan on the Treatment of Pouchitis

Universitätsklinikum Hamburg-Eppendorf — NA

TrialNOT YET RECRUITING
Nov 2024A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Takeda — PHASE3

TrialRECRUITING
Sep 2024Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Maia Kayal — EARLY_PHASE1

TrialRECRUITING
Jul 2024Rifaximin for the Secondary Prevention of Recurrent Pouchitis

University of North Carolina, Chapel Hill — PHASE4

TrialRECRUITING
Nov 2023Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)

Exegi Pharma, LLC — PHASE1, PHASE2

TrialRECRUITING
Mar 2020the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

Nantes University Hospital — PHASE3

TrialACTIVE NOT RECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Pouchitis.

8 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

8 recruitingView all trials with filters →
Phase 32 trials
A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis
Phase 3
Actively Recruiting
PI: Study Director (Takeda) · Sites: Leuven, Vlaams-Brabant; Zagreb +12 more · Age: 217 yrs
the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis
Phase 3
Active
· Sites: Angers; Clermont-Ferrand +11 more · Age: 1899 yrs
Phase 42 trials
Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
Phase 4
Actively Recruiting
PI: Edward Barnes, MD, MPH (University of North Carolina) · Sites: Los Angeles, California; Rochester, Minnesota +3 more · Age: 1880 yrs
Rifaximin for the Secondary Prevention of Recurrent Pouchitis
Phase 4
Actively Recruiting
PI: Edward Barnes, MD, MPH (University of North Carolina) · Sites: New York, New York; Chapel Hill, North Carolina · Age: 1874 yrs
Phase 22 trials
Fecal Microbiota Transplantation for Pouchitis
Phase 2
Actively Recruiting
· Sites: Hamilton, Ontario · Age: 1899 yrs
CLF065 for Chronic Pouchitis
Phase 2
Actively Recruiting
· Sites: Los Angeles, California · Age: 1880 yrs
Other1 trial
Inflammatory Bowel Diseases Remission Registry
Actively Recruiting
· Sites: Tel Aviv · Age: 1880 yrs

Specialists

25 foundView all specialists →
MM
Maia Kayal, MD, MS
NEW YORK, NY
Specialist
PI on 1 active trial
LM
Laura Raffals, MD
ROCHESTER, MN
Specialist
PI on 1 active trial1 Pouchitis publication
OP
Ole Thorlacius-Ussing, Professor
Specialist
PI on 3 active trials
JP
Jens Kjeldsen, Phd
Specialist
PI on 1 active trial
EM
Edward Barnes, MD, MPH
Specialist
PI on 2 active trials
BM
Bo Shen, M.D.
CLEVELAND, OH
Specialist
PI on 1 active trial
CD
Chris Dunk
Specialist
PI on 1 active trial
CB
Carl Brown
Specialist
PI on 1 active trial113 Pouchitis publications
MP
Marc Ferrante, MD, PhD
SHELTON, CT
Specialist
PI on 1 active trial
VM
Virginia O. Shaffer, MD
CHICAGO, IL
Specialist
PI on 1 active trial
AM
Anna Lepistö, PhD, MD
Specialist
PI on 1 active trial1 Pouchitis publication
FM
Francis Farraye, MD
JACKSONVILLE, FL
Specialist
PI on 1 active trial
LP
Lars G Börjesson, Ass Prof
Specialist
PI on 1 active trial
DM
Darrell Pardi, MD
Specialist
PI on 2 active trials
JM
Julia Collins, MS
Specialist
PI on 1 active trial
IA
Imerio Angriman
Specialist
PI on 1 active trial
DP
Darrell S. Pardi
Specialist
PI on 1 active trial
JG
Jianfeng Gong
Specialist
PI on 2 active trials
SS
Sidhartha Sinha
STANFORD, CA
Specialist
PI on 1 active trial
PR
Paul A. Rufo
BOSTON, MA
Specialist
PI on 1 active trial
SH
Samuel Huber
Specialist
PI on 1 active trial
AL
Amy L Lightner
FULTON, MO
Specialist
PI on 1 active trial
AM
A. Masclee
Specialist
PI on 1 active trial
HH
Hans Herfarth
CHAPEL HILL, NC
Specialist
PI on 2 active trials

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Pouchitis.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Pouchitis

Disease timeline:

New recruiting trial: Fecal Microbiota Transplantation for Pouchitis

A new clinical trial is recruiting patients for Pouchitis

New recruiting trial: Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch

A new clinical trial is recruiting patients for Pouchitis

New recruiting trial: A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

A new clinical trial is recruiting patients for Pouchitis

New recruiting trial: CLF065 for Chronic Pouchitis

A new clinical trial is recruiting patients for Pouchitis

New recruiting trial: Rifaximin for the Secondary Prevention of Recurrent Pouchitis

A new clinical trial is recruiting patients for Pouchitis

New recruiting trial: Inflammatory Bowel Diseases Remission Registry

A new clinical trial is recruiting patients for Pouchitis

New recruiting trial: Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF)

A new clinical trial is recruiting patients for Pouchitis

New recruiting trial: Fecal Microbiota Transplant for Patients With Chronic Pouchitis

A new clinical trial is recruiting patients for Pouchitis

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Pouchitis

What is Pouchitis?

Pouchitis is an inflammatory condition affecting the ileal pouch (also called a J-pouch or ileal pouch-anal anastomosis, IPAA) that is surgically created after total proctocolectomy, most commonly performed in patients with ulcerative colitis or familial adenomatous polyposis. The ileal pouch serves as an internal reservoir for stool after the colon and rectum have been removed. Pouchitis represents the most common long-term complication following this surgery, characterized by inflammation of the mucosal lining of the pouch. The condition primarily affects the gastrointestinal system, with k

How is Pouchitis inherited?

Pouchitis follows a multifactorial inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Pouchitis typically begin?

Typical onset of Pouchitis is adult. Age of onset can vary across affected individuals.

Are there clinical trials for Pouchitis?

Yes — 8 recruiting clinical trials are currently listed for Pouchitis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Pouchitis?

25 specialists and care centers treating Pouchitis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.