A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention

• Register: ClinicalTrials.gov
• Last refreshed on: 4 October 2021
• Main ID: NCT03537157
• Date of registration: 15/05/2018
• Prospective Registration: No
• Primary sponsor: Alfasigma S.p.A.
• Public title: A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention STOP-PER
• Scientific title: A Phase II, Multicentre, Double-blind, Randomised, Placebo-controlled Study of Rifaximin Delayed Release 400 mg Tablet: Clinical Efficacy and Safety in the Prevention of Post-operative Endoscopic Crohn's Disease Recurrence
• Date of first enrolment: November 16, 2017
• Target sample size: 43
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03537157
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Maria Grimaldi, MD
• Affiliation: Alfasigma S.p.A.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Crohn Disease with curative ileocolonic resection

- Randomization within 45 days from ileocolonic resection or end or loop ileostomy
within last year and closure occurred within 45 days from randomization

- Fecal stream restoration at least 14 days prior to randomization

- Presence of at least one risk factor for recurrence

- Pregnancy protection on board during the study for childbearing female subjects

Exclusion Criteria:

- Presence of CD proximally or distally to the site of resection

- Patients with strictureplasties at index surgery or ileorectal anastomosis

- patients with active perianal CD

- Patient treated with other treatments usually utilised for CD

- Patients with active diseases with gastrointestinal involvement

- intestinal obstruction or pseudo-obstruction

- Patients presenting diarrhoea plus fever or bloody stools

- Positivity to clostridium difficile toxin

- Severe hepatic or renal impairment

- Presence of severe cardiac insufficiency

- Hypersensitivity to rifamycin antimicrobial agents

- other conditions that would interfere or prevent the study completion

- Pregnancy



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Rifaximin delayed release tablets

Other: Placebo

Primary Outcome(s)

Rutgeerts score [Time Frame: 26 weeks]

Secondary ID(s)

RETIPC/01/17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cromsource