drugset / Trial / NCT02033408

Manipulating the Microbiome in IBD by Antibiotics and FMT

NCT02033408

Completed 28 enrolled Shaare Zedek Medical Center
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2014-01
Primary completion
2018-12
Completion
2021-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 50 mg/kg Oral
Subject Ciprofloxacin Small molecule 10 mg/kg Oral
Subject Doxycycline Small molecule 2 mg/kg Oral
Subject Gentamicin Small molecule 2.5 mg/kg Oral
Subject Metronidazole Small molecule 5 mg/kg Oral
Subject Vancomycin Other / unclassified 125 mg Oral
Subject Vancomycin Other / unclassified 250 mg Oral
Background Methylprednisolone Other / unclassified 1.5 mg/kg