Trials / Completed
CompletedNCT02033408
Manipulating the Microbiome in IBD by Antibiotics and FMT
Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Shaare Zedek Medical Center · Academic / Other
- Sex
- All
- Age
- 2 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2018-12-01
- Completion
- 2021-01-01
- First posted
- 2014-01-10
- Last updated
- 2021-10-08
Locations
12 sites across 6 countries: Canada, Finland, Israel, Italy, Poland, Spain
Source: ClinicalTrials.gov record NCT02033408. Inclusion in this directory is not an endorsement.