Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease (Holiday)

NCT02765256 Phase 2 COMPLETED Results posted

To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) that is refractory to conventional, immunosuppressive therapy.

Details

Lead sponsor	University of Pennsylvania
Phase	Phase 2
Status	COMPLETED
Enrolment	8
Start date	2016-08
Completion	2018-12

Conditions

• Crohn's Disease

Interventions

• Fluconazole
• Vancomycin
• Neomycin
• Ciprofloxacin
• Polyethylene Glycol 3350
• Promethazine
• Fluconazole placebo

Primary outcomes

• Change in Disease Activity by Harvey Bradshaw Index — enrollment visit (baseline) and 15 days
  The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease. General Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points Abdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points Abdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points Complications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1
• Change in Disease Activity by Fecal Calprotectin (FCP) — enrollment visit (baseline) and 15 days
  The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation.

Countries

United States