Manipulating the Microbiome in IBD by Antibiotics and FMT

Crohn's Colitis Clinical Trial

— FMT  

Official title:

Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033408
• Other study ID #: ABCS-FMT-01
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2021

Study information

• Verified date: April 2019
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2021
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• AB (antibiotics)
PO Vancomycin 250mgX4/d for 3 weeks PO Amoxycillin 50mg/Kg divided by 3 (up to 500mgX3/d) - for 3 weeks 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.
• CS (corticosteroids) Only
methylprednisolone (1.5mg/kg up to 60mg daily in two divided doses) PO Metronidazole 5mg/Kg X3/d (up to 250mgX3/d) - for 3 weeks

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children (SickKids)	Toronto
Finland	Hospital for Children and Adolescents Helsinki University Hospital	Helsinki
Israel	Soroka Medical Center	Beer Sheva
Israel	Rambam Medical Cener	Haifa
Israel	Wolfson Medical Center	Holon
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Schneider Medical Center	Petach Tikva
Israel	Sheba Medical Center	Ramat Gan
Italy	Università degli Studi di Napoli "Federico II"	Napoli
Italy	Sapienza University of Rome	Rome
Poland	Univeristy Children's Hospital in Krakow	Krakow
Spain	Hospital Regional Universitario Carlos Haya Málaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Countries where clinical trial is conducted

Canada,  Finland,  Israel,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score		at day 5 after treatment (compared between the two treatment groups).
Secondary	Remission rates	defined by PUCAI<10 without the need for second line therapy (anti TNF (Tumor Necrosis Factor), cyclosporine or tacrolimus) or colectomy.	at days 7, separately at discharge, separately at day 14, and separately at 90 days.
Secondary	Number of patients with PUCAI<35 points	without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy.	at day 5
Secondary	The need for second line therapy or colectomy by discharge		by 90 days and at 1 year
Secondary	Rate of steroid	defined as a course longer than 3 month with an unsuccessful attempt to wean steroids or cumulative steroid treatment months of 4 months, during the year.	dependency at 1 year
Secondary	Need for subsequent admission		by 1 year
Secondary	Calprotectin levels		at 5 and 14 days after treatment.
Secondary	Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL)		at days 5 and 14 after treatment.
Secondary	Change in microbiome pattern.		3 years from baseline
Secondary	Rate of C. difficile infection		at days 5 and 14 after treatment.