Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease
that failed conventional treatment

- Age 18 or older; must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures.
- Diagnosis of Crohn’s disease ≥3 months before screening.
- Objective evidence of inflammation at baseline as defined by endoscopy with mucosal ulcers in the ileum or colon or both, and a SES-CD score of 3-15.
- Concurrent therapies with stable doses of azathioprine, mercaptopurine, MTX or steroids (prednisolone ≤30 mg/dl or budesonide ≤9 mg per day) are permitted. Tapering of corticosteroids is mandatory.

- Current use of i.v. corticosteroids.
- Imminent need for in-hospital treatment.
- Pregnancy or lactation.
- Previous or current treatment with investigational drug; current or past treatment within 6 months prior to randomization with a biological agent.
- Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
- Other significant illnesses that may interfere with the study, stricture causing obstructive symptoms, or fistulising disease complicated by infection,
- Opiates use or drugs and/or alcohol abuse.
- Concomitant use of TNA alpha antagonist, Integrin antagonist, Interleukin antagonist, Cyclosporine, thalidomide, tacrolimus and any JAK inhibitors. Wash out period mandatory.