the etiology of Inflammatory Bowel Diseases (IBD) is closely associated with the gut microbiome. The results of previous studies on the effectiveness of antibiotics and fecal macrobiota transplantation (FMT) are contradicting. Aims: to evaluate the effectiveness of wide-spectrum antibiotic regimens in acute severe colitis in an addition to standard corticosteroid therapy (UC and isolated "UC-like" Crohn's colitis). The secondary aim is to assess the outcome of FMT in those not responding to five days of therapy (in either arm). As an exploratory aim, any IBD patient with a resistant disease to at least two immunosuppressive medications, may be treated with either interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
1. PO Vancomycin 250mgX4/d for 3 weeks 2. PO Amoxycillin 50mg/Kg divided by 3 (up to 500mgX3/d) - for 3 weeks 3. PO Doxycycline 2mg/kg X2/d (up to 100mgX2/d) - for 3 weeks; OR- For children younger than 8 years: PO Ciprofloxacin 10mg/Kg X2/2 (up to 250mgX2/d) for 3 weeks Patients with known allergy to one of the drugs may be treated with oral Gentamycin (2.5mg/KgX3/d) for 3 weeks instead of the allergenic drug.
1. methylprednisolone (1.5mg/kg up to 60mg daily in two divided doses) 2. PO Metronidazole 5mg/Kg X3/d (up to 250mgX3/d) - for 3 weeks
The Hospital for Sick Children (SickKids)
Toronto, Canada
Hospital for Children and Adolescents Helsinki University Hospital
Helsinki, Finland
Soroka Medical Center
Beersheba, Israel
Rambam Medical Cener
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Schneider Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Università degli Studi di Napoli "Federico II"
Napoli, Italy
Sapienza University of Rome
Rome, Italy
...and 2 more locations
Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score
Time frame: at day 5 after treatment (compared between the two treatment groups).
Remission rates
defined by PUCAI\<10 without the need for second line therapy (anti TNF (Tumor Necrosis Factor), cyclosporine or tacrolimus) or colectomy.
Time frame: at days 7, separately at discharge, separately at day 14, and separately at 90 days.
Number of patients with PUCAI<35 points
without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy.
Time frame: at day 5
The need for second line therapy or colectomy by discharge
Time frame: by 90 days and at 1 year
Rate of steroid
defined as a course longer than 3 month with an unsuccessful attempt to wean steroids or cumulative steroid treatment months of 4 months, during the year.
Time frame: dependency at 1 year
Need for subsequent admission
Time frame: by 1 year
Calprotectin levels
Time frame: at 5 and 14 days after treatment.
Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL)
Time frame: at days 5 and 14 after treatment.
Change in microbiome pattern.
Time frame: 3 years from baseline
Rate of C. difficile infection
Time frame: at days 5 and 14 after treatment.
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