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NCT02203955 Clinical Trial

Study of Sc-FOS for Pouchitis Prevention

Pouchitis Clinical Trial

Official title:
Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02203955
Other study ID # 14-001220
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2014
Est. completion date December 2018

Study information
Verified date February 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria:

1. Age 18-65 years.

2. History of ulcerative colitis

3. Ileostomy closure after IPAA

4. Ability to give appropriate consent

Exclusion Criteria:

1. Crohn's disease.

2. Perianal disease (including abscess, fissure, or stricture)

3. Pregnancy

4. Lactation

5. Concurrent treatment for IBD or pouchitis

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Short-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally for 12 months
• Maltodextrin
4 chews (maltodextrin) daily for 12 months

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (=7 points) and 'no pouchitis' (<7 points). baseline, 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04979832 - GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery Phase 1/Phase 2
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
Recruiting NCT03524352 - the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis Phase 3
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

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