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

NCT03537157 | Terminated Phase 2 DMC

• 1 other identifier: RETIPC/01/17
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's Disease (CD) is a chronic pathology characterized by exacerbations and remissions. Recurrent inflammation can cause bowel strictures, fistulae (often perianal) or abscesses. CD often requires intestinal resection. Surgery in CD is not curative, Therefore, endoscopic follow-up 6-12 months after surgery is recommended. Given the association between enteric bacteria and postoperative CD recurrence, antibacterial agents were shown to be effective in reducing the severity of endoscopic recurrence, but prolonged administration causes significant toxicity. The efficacy of "systemic antibiotics" and the experimental evidence of the central role of luminal flora as an essential factor in the development of post chirurgic CD recurrence provide the rationale for evaluating a locally acting antibiotic like Rifaximin.

Conditions

Crohn Disease

Keywords

Crohn Disease recurrence

Outcome Measures

Primary Outcomes (1)

• Rutgeerts score

  Rate of patients presenting a rutgeerts score higher than or equal to i2 will be considered as endpoint. Endoscopic remission will be defined as a Rutgeerts score of i0 or i1 and recurrence defined as a Rutgeerts score of ≥i2 (i0, no lesions; i1, ≤5 aphthous lesions; i2, \>5 aphthous lesions or anastomotic ulcer \<1 cm; i3, diffuse aphthous ileitis with diffusely inflamed mucosa; i4, diffuse inflammation with large ulcers, nodules, and/or narrowing) at the anastomosis and neoterminal ileum. (Rutgeerts P, 1990)

  26 weeks

Study Arms (2)

Rifaximin delayed release tablets

EXPERIMENTAL

Two 400 mg tablets twice a day (total daily dose 1600 mg) for 26 weeks

Drug: Rifaximin delayed release tablets

Placebo

PLACEBO COMPARATOR

Two placebo tablets twice a day for 26 weeks

Other: Placebo

Interventions

Rifaximin delayed release tablets DRUG

Active intervention

Rifaximin delayed release tablets

Placebo OTHER

Comparator placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alfasigma S.p.A.: lead
• Cromsource: collaborator

Study Sites (1)

Humanitas Clinical Research Center

Rozzano, 20089, Italy

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Maria Grimaldi, MD

  Alfasigma S.p.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active drug will be masked with a placebo identical to the active drug. Patients will be identified by a code and central readers will not have access to the administered treatments
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a multicentre, randomised, double-blind, placebo controlled trial to assess the efficacy and safety of Rifaximin delayed release 400 mg tablet (800 mg BID daily) administered for 26 weeks in the prevention of endoscopic Crohn's disease recurrence following ileocolonic resection, in patients who had undergone curative ileocolonic resection, with ileocolonic anastomosis for Crohn's disease.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: November 16, 2017
• Primary Completion: July 15, 2020
• Study Completion: July 29, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)