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Manipulating the Microbiome in IBD by Antibiotics and FMT (FMT)

This study is currently recruiting participants.
Verified April 2016 by Shaare Zedek Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02033408
First Posted: January 10, 2014
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shaare Zedek Medical Center
  Purpose

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.


Condition Intervention Phase
Exacerbation of Ulcerative Colitis Ulcerative Colitis, Active Severe Crohn's Colitis Drug: AB (antibiotics) Drug: CS (corticosteroids) Only Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score [ Time Frame: at day 5 after treatment (compared between the two treatment groups). ]

Secondary Outcome Measures:
  • Remission rates [ Time Frame: at days 7, separately at discharge, separately at day 14, and separately at 90 days. ]
    defined by PUCAI<10 without the need for second line therapy (anti TNF (Tumor Necrosis Factor), cyclosporine or tacrolimus) or colectomy.

  • Number of patients with PUCAI<35 points [ Time Frame: at day 5 ]
    without the need for second line therapy (anti TNF, cyclosporine or tacrolimus) or colectomy.

  • The need for second line therapy or colectomy by discharge [ Time Frame: by 90 days and at 1 year ]
  • Rate of steroid [ Time Frame: dependency at 1 year ]
    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.

  • Need for subsequent admission [ Time Frame: by 1 year ]
  • Calprotectin levels [ Time Frame: at 5 and 14 days after treatment. ]
  • Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL) [ Time Frame: at days 5 and 14 after treatment. ]
  • Change in microbiome pattern. [ Time Frame: 3 years from baseline ]
  • Rate of C. difficile infection [ Time Frame: at days 5 and 14 after treatment. ]

Estimated Enrollment: 28
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotics in addition to steroids

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
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.

Other Names:
  • Ciprofloxacin-Ciprodex®
  • Doxycycline-Doxylin®
  • Gentamycin-Gentamicin®
  • Amoxicillin-Amoxyclav®
  • Vancomycin-Vanco-Teva®
Active Comparator: Steroids only
methylprednisolone-1.5mg/kg up to 60mg daily in two divided doses
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
Other Name: Metronidazole-Flagyl®
Open arm
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
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.

Other Names:
  • Ciprofloxacin-Ciprodex®
  • Doxycycline-Doxylin®
  • Gentamycin-Gentamicin®
  • Amoxicillin-Amoxyclav®
  • Vancomycin-Vanco-Teva®
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
Other Name: Metronidazole-Flagyl®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033408


Contacts
Contact: Dana Marcus, MSc. +972-2-5645524 danam@szmc.org.il
Contact: Gili Focht, MBA +972-2-5645028 gilif@szmc.org.il

Locations
Canada
The Hospital for Sick Children (SickKids) Recruiting
Toronto, Canada
Contact: Diane Tomalty, SSC       diane.tomalty@sickkids.ca   
Principal Investigator: Anne Griffiths, MD         
Sub-Investigator: Eberhard Lurz, MD         
Finland
Hospital for Children and Adolescents Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Anne Nikkonen, RN    +358 45 1285886      
Principal Investigator: Kaija-Leena Kolho, MD         
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel
Contact: Tamar Gibor       TamarGib@clalit.org.il   
Principal Investigator: Baruch Yerushalmi, MD         
Rambam Medical Cener Recruiting
Haifa, Israel
Contact: Liat Pritzker, SSC       liat.rambam@gmail.com   
Principal Investigator: Ron Shaoul, MD         
Wolfson Medical Center Recruiting
Holon, Israel
Contact: chen sarbagili, M.Sc    +972-3-5028878    ibd.chen@gmail.com   
Principal Investigator: Arie Levine, MD         
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Dana Marcus, MSc    +972-2-5645524    danam@szmc.org.il   
Principal Investigator: Dan Turner, MD PHD         
Schneider Medical Center Recruiting
Petach Tikva, Israel
Contact: Reut Klein       reutkl@clalit.org.il   
Principal Investigator: Amit Assa, MD         
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Katya Ulanenko, SSC       Katya.Ulanenko@sheba.health.gov.il   
Principal Investigator: Batia Weiss, MD         
Sub-Investigator: Tzippora Shalem, MD         
Sub-Investigator: Avishay Lahad, MD         
Italy
Università degli Studi di Napoli "Federico II" Not yet recruiting
Napoli, Italy
Contact: Erasmo Miele, MD       erasmo.miele@unina.it   
Sub-Investigator: Erasmo Miele, MD         
Principal Investigator: Annamaria Staiano, MD         
Sapienza University of Rome Recruiting
Rome, Italy
Contact: Marina Aloi, MD       marina.aloi@gmail.com   
Principal Investigator: Marina Aloi, MD         
Poland
Univeristy Children's Hospital in Krakow Not yet recruiting
Krakow, Poland
Contact: Malgorzata Sladek, MD       misladek@cyf-kr.edu.pl   
Principal Investigator: Malgorzata Sladek, MD         
Spain
Hospital Regional Universitario Carlos Haya Málaga Not yet recruiting
Malaga, Spain
Contact: Victor Navas-Lopez, MD       victorm.navas.sspa@juntadeandalucia.es   
Principal Investigator: Victor Navas-Lopez, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Dan Turner, MD Shaare Zedek Medical Center
  More Information

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02033408     History of Changes
Other Study ID Numbers: ABCS-FMT-01
First Submitted: December 3, 2013
First Posted: January 10, 2014
Last Update Posted: March 28, 2017
Last Verified: April 2016

Keywords provided by Shaare Zedek Medical Center:
IBD: Inflammatory Bowel Diseases
CD: Crohn's Disease
UC: Ulcerative Colitis
ASC: Acute Severe Colitis
FMT: Fecal Microbiota Transplantation
PUCAI: Pediatric Ulcerative Colitis Activity Index
Ciprofloxacin, Doxycycline, Gentamycin, amoxicillin, vancomycin, metronidazole,ciprofloxacin

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Bacterial Agents
Amoxicillin
Vancomycin
Doxycycline
Ciprofloxacin
Gentamicins
Antibiotics, Antitubercular
Metronidazole
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Antitubercular Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents