A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.

Phase 1

Conditions: Inflammatory Bowel Disease, Crohn's disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2019-000852-32-NL

Lead Sponsor: ErasmusMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 122

Inclusion Criteria

•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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

•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.