Manipulating the Microbiome in IBD by Antibiotics and FMT

NACompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

December 31, 2018

Study Completion Date

January 31, 2021

Conditions
Exacerbation of Ulcerative ColitisUlcerative Colitis, Active SevereCrohn's Colitis
Interventions
DRUG

AB (antibiotics)

"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."

DRUG

CS (corticosteroids) Only

"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"

Trial Locations (12)

9103102

Shaare Zedek Medical Center, Jerusalem

Unknown

The Hospital for Sick Children (SickKids), Toronto

Hospital for Children and Adolescents Helsinki University Hospital, Helsinki

Soroka Medical Center, Beersheba

Rambam Medical Cener, Haifa

Wolfson Medical Center, Holon

Schneider Medical Center, Petah Tikva

Sheba Medical Center, Ramat Gan

"Università degli Studi di Napoli Federico II", Napoli

Sapienza University of Rome, Rome

Univeristy Children's Hospital in Krakow, Krakow

Hospital Regional Universitario Carlos Haya Málaga, Málaga

All Listed Sponsors
lead

Shaare Zedek Medical Center

OTHER

NCT02033408 - Manipulating the Microbiome in IBD by Antibiotics and FMT | Biotech Hunter | Biotech Hunter