Personalized antibiotic therapy in combination with standard therapy to achieve a fecal profile associated with prolonged complaint-free period in pediatric Crohn’s Disease

Phase 1

• Conditions: Crohn's Disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-004219-29-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-04
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Provision of signed and dated informed consent form (and assent form, as applicable)
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 3 to 17 years
4. Diagnosed with CD according to standard clinical and histological criteria, within 36 months of week 0
5. Exhibiting mild to moderate symptoms of active disease, as determined by a PCDAI score >10 (or >7.5 excluding the height item) and =37.5
6. Evidence of active inflammation based on either: fecal calprotectin level >=250 microgram/g (local laboratory or pre-arranged sponsor testing) within 30 days prior to week 0 visit; or according to accepted endoscopic and histologic evidence obtained during an endoscopy procedure completed within 30 days prior to Week 0 Visit.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Current or previous use of anti-TNF or other biologic therapy
2.Presence of stricturing, penetrating (intestinal or perianal) and/or fistulizing CD.
3.Pregnancy or lactation
4.Have undergone intestinal resection
5.Laboratory diagnosis of Clostridium Difficile Infection (CDI), if performed for clinical indication
6.Treatment with another investigational drug or other intervention within 30 days before week 0
7.Risk factors for arrhythmia including history of prolonged QTc, hypokalemia or hypomagnesemia, resting bradycardia, or concurrent treatment with other drugs with potential for QT prolongation.
8.History of Cockayne syndrome
9.Prior diagnosis of any hematologic condition/blood dyscrasia which may result in leukopenia (even if leukocyte count is normal at screening)
10.Known allergy or intolerance to azithromycin or metronidazole
11.Subjects who received IV anti-infective within 35 days prior to week 0 visit or oral anti-infectives within 14 days prior to the week 0 visit.
12.Subject on oral aminosalicylates who has not been on stable doses for greater than, or discontinued within, at least 14 days prior to week 0.
13.Subject on cyclosporine, tacrolimus or mycophenolate mofetil. Stable doses (no change within 14 days prior to week 0) of Azathioprine, 6-mercaptopurine or MTX are not a reason for exclusion.
14.Subject who received fecal microbial transplantation within 35 days prior to week 0 visit.
15.Screening laboratory and other analyses show any of the following abnormal results:
o AST, ALT > 2 X upper limit of the reference range (as determined locally at each site)
o Urea, Creatinine > 1.5X upper limit of the reference range (as determined locally at each site)
o White blood cell (WBC) count < 3.0 X 109/L
o Total bilirubin >= 20 micromol/liter (1.17mg/dl); except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome
o Hemoglobin < 80 gram/liter
o Platelets < 100,000/µL

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified