the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant

Status Recruiting

Clinical Trial Summary

Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available. Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Pouchitis

Clinical Trial Details

NCT number	NCT03524352
Study type	Interventional
Source	Nantes University Hospital
Contact	Trang POISSON
Phone	+33 2 40 08 75 59
Email	caroline.trang@chu-nantes.fr
Status	Recruiting
Phase	Phase 3
Start date	March 12, 2020
Completion date	May 12, 2028

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See also
Status	Clinical Trial	Phase
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Terminated	`NCT00061282` - Clotrimazole Enemas for Pouchitis in Children and Adults	Phase 1/Phase 2
Not yet recruiting	`NCT05829109` - Fecal Microbiota Transplant for Patients With Chronic Pouchitis	Early Phase 1
Recruiting	`NCT03136419` - Microbiota and Immune microEnvironment in Pouchitis	N/A
Withdrawn	`NCT04640155` - Treating Chronic Pouchitis With a Low FODMAP Diet	N/A
Completed	`NCT02201186` - To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis	Phase 2
Completed	`NCT02790138` - A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis	Phase 4
Not yet recruiting	`NCT01202396` - The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis	N/A
Completed	`NCT02428361` - Fecal Microbiota Transplant (FMT) for Pouchitis	Early Phase 1
Completed	`NCT03538366` - Fecal Microbiota Transplantation for Chronic Pouchitis	N/A
Completed	`NCT04763564` - Efficacy of Liraglutide Therapy in Patients With IPAA	Phase 2
Terminated	`NCT00583531` - Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis	Phase 2
Completed	`NCT04820413` - Faecal Microbiota Transplantation From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis	N/A
Not yet recruiting	`NCT06443502` - A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis	Phase 3
Recruiting	`NCT04089345` - Stelara fOr ChRonic AntibioTic rEfractory pouchitiS	Phase 3
Not yet recruiting	`NCT03526796` - Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis	N/A
Terminated	`NCT02782325` - Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)	Phase 1/Phase 2
Completed	`NCT02828410` - Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA	N/A
Recruiting	`NCT05578313` - Inflammatory Bowel Diseases (IBD) Cannabis Registry
Not yet recruiting	`NCT06316999` - Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis — POCA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms