Manipulating the Microbiome in IBD by Antibiotics and FMT

Shaare Zedek Medical Center

Status: Completed

Conditions: Exacerbation of Ulcerative Colitis; Ulcerative Colitis, Active Severe; Crohn's Colitis

Treatments: Drug: AB (antibiotics); Drug: CS (corticosteroids) Only

Study type: Interventional

Funder types: Other

Identifiers

NCT02033408

ABCS-FMT-01

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 2 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children over the age the 2 years and adults of all ages with established diagnosis of UC using standard criteria (26, 27).
• Admission for IV steroid therapy
• PUCAI of at least 65 points at admission (i.e. severe attack)
• PUCAI>45 at enrollment
• Ability to swallow antibiotics (pills or syrup)

Exclusion criteria

• Change in dose or intervals of anti-TNF within the past 2 months prior to admission.
• Disease confined to the rectum (Proctitis).
• Antibiotic use in the past 4 weeks.
• Any known erosive inflammation anywhere in the small bowel or esophagus.
• Any proven infection such as positive stool culture, parasite or C. difficile, urinary tract infection, cellulitis, abscess, pneumonia, line-infections etc.
• Fever >38.5, or >38.0c thought to be unrelated to the inflammatory process of active UC.
• The probable need for second line medical therapy (infliximab, cyclosporine, tacrolimus) or colectomy within 5 days of enrollment, as judged by the caring physician.
• Known allergy to more than one antibiotic regimen from the list below.
• Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 3 patient groups

Antibiotics in addition to steroids

Experimental group

Description:

methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses and in addition the following antibiotics: 1. PO Vancomycin 250mg 4 times a day for 3 weeks (children under age 8 125mgX4/d for 3 weeks) 2. PO Amoxycillin 50mg per Kg divided by 3 (up to 500mg 3 times a day) - for 3 weeks 3. PO Metronidazole 5mg per Kg 3 times a day (up to 250mg 3 times a day) - for 3 weeks 4. PO Doxycycline 2mg per kg twice a day (up to 100mg twice a day) - for 3 weeks; OR- For children younger than 7 years: PO Ciprofloxacin 10mg per Kg twice a day (up to 250mg twice a day) for 3 weeks

Treatment:

Drug: AB (antibiotics)

Steroids only

Active Comparator group

Description:

methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses

Treatment:

Drug: CS (corticosteroids) Only

Open arm

Other group

Description:

either the antibiotics and/or FMT (fecal microbiome transplant) may be administered in a non-randomized, uncontrolled open-label arm to any resistant IBD patients

Treatment:

Drug: AB (antibiotics)

Drug: CS (corticosteroids) Only