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Manipulating the Microbiome in IBD by Antibiotics and FMT

NCT02033408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-10-08

No results posted yet for this study

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.

Conditions

  • Exacerbation of Ulcerative Colitis
  • Ulcerative Colitis, Active Severe
  • Crohn'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

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Dan Turner, MD · Shaare Zedek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-12-31
Completion
2021-01-31

Countries

  • Canada
  • Finland
  • Israel
  • Italy
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02033408 on ClinicalTrials.gov