EUCTR2015-001900-76-ITActive, not recruitingPhase 1
Manipulating the microbiome in IBD by antibiotics and fecal microbiota transplantation (FMT): a randomized controlled trial - PRASCO
MBERTO I - POLICLINICO DI ROMA0 sites28 target enrollmentStarted: September 7, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 28
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Children between 6 and 18 years with established diagnosis of UC and IBDU using standard criteria (1, 2).
- •-Admission for IV steroid therapy
- •-PUCAI of at least 65 points at admission (i.e. severe attack)
- •-PUCAI>45 at enrolment
- •-Ability to swallow antibiotics (pills or syrup)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •-Disease confined to the rectum (Proctitis).
- •-Antibiotic use for > 3 days in the past 2 weeks, or patients receiving antibiotics at enrollment.
- •-Any proven infection such as positive stool culture, parasite or C. difficile, urinary tract infection, cellulitis, abscess, pneumonia, line-infections etc.
- •-Fever >38.5, or >38.0c thought to be unrelated to the inflammatory process of active UC.
- •-The need for imminent surgery (peritoneal abdominal signs, toxic megacolon (3), massive bleeding etc).
- •-The probable need for second line medical therapy (infliximab, cyclosoporine,tacrolimus) or colectomy within 5 days of enrolment, as judged by the caring physician.
- •-Known allergy to more than one antibiotic regimen from the list below.
Investigators
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