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Manipulating the Microbiome in IBD by Antibiotics and FMT

Information source: Shaare Zedek Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Exacerbation of Ulcerative Colitis; Ulcerative Colitis, Active Severe; Crohn's Colitis

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

Phase: Phase 4

Status: Recruiting

Sponsored by: Shaare Zedek Medical Center

Official(s) and/or principal investigator(s):
Dan Turner, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center

Overall contact:
Dana Marcus, MSc., Phone: +972-2-5645524, Email: danam@szmc.org.il

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score

Secondary outcome:

Remission rates

Number of patients with PUCAI<35 points

The need for second line therapy or colectomy by discharge

Rate of steroid

Need for subsequent admission

Calprotectin levels

Rate of gastrointestinal carriage of resistant organisms (VRE, ESBL)

Change in microbiome pattern.

Rate of C. difficile infection

Eligibility

Minimum age: 2 Years. Maximum age: 75 Years. Gender(s): Both.

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:

- Disease confined to the rectum (Proctitis).

- Antibiotic use in the past 2 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.

- Use of anti-TNF any time prior to admission

Locations and Contacts

Dana Marcus, MSc., Phone: +972-2-5645524, Email: danam@szmc.org.il

The Hospital for Sick Children (SickKids), Toronto, Canada; Not yet recruiting
Suzan O'Donnell, Email: suzan.odonnell@sickkids.ca
Anne Griffiths, MD, Principal Investigator
Eberhard Lurz, MD, Sub-Investigator

Hospital for Children and Adolescents Helsinki University Hospital, Helsinki, Finland; Recruiting
Anne Nikkonen, RN, Phone: +358 45 1285886
Kaija-Leena Kolho, MD, Principal Investigator

Soroka Medical Center, Beer Sheva, Israel; Recruiting
Tamar Gibor, Email: TamarGib@clalit.org.il
Baruch Yerushalmi, MD, Principal Investigator

Rambam Medical Cener, Haifa, Israel; Not yet recruiting
Ron Shaoul, MD, Email: ron.shaoul@gmail.com
Ron Shaoul, MD, Principal Investigator

Wolfson Medical Center, Holon, Israel; Recruiting
chen sarbagili, M.Sc, Phone: +972-3-5028878, Email: ibd.chen@gmail.com
Arie Levine, MD, Principal Investigator

Shaare Zedek Medical Center, Jerusalem 9103102, Israel; Recruiting
Dana Marcus, MSc, Phone: +972-2-5645524, Email: danam@szmc.org.il
Dan Turner, MD PHD, Principal Investigator

Schneider Medical Center, Petach Tikva, Israel; Recruiting
Reut Klein, Email: reutkl@clalit.org.il
Amit Assa, MD, Principal Investigator

Sheba Medical Center, Ramat Gan, Israel; Recruiting
Tzippora Shalem, MD, Email: tzippi.shalem@gmail.com
Batia Weiss, MD, Email: Batya.Vais@sheba.health.gov.il
Batia Weiss, MD, Principal Investigator
Tzippora Shalem, MD, Sub-Investigator
Avishay Lahad, MD, Sub-Investigator

Università degli Studi di Napoli "Federico II", Napoli, Italy; Not yet recruiting
Erasmo Miele, MD, Email: erasmo.miele@unina.it
Erasmo Miele, MD, Sub-Investigator
Annamaria Staiano, MD, Principal Investigator

Sapienza University of Rome, Rome, Italy; Not yet recruiting
Marina Aloi, MD, Email: marina.aloi@gmail.com
Marina Aloi, MD, Principal Investigator

Univeristy Children's Hospital in Krakow, Krakow, Poland; Not yet recruiting
Malgorzata Sladek, MD, Email: misladek@cyf-kr.edu.pl
Malgorzata Sladek, MD, Principal Investigator

Hospital Regional Universitario Carlos Haya Málaga, Malaga, Spain; Not yet recruiting
Victor Navas-Lopez, MD, Email: victorm.navas.sspa@juntadeandalucia.es
Victor Navas-Lopez, MD, Principal Investigator

Additional Information

Starting date: January 2014
Last updated: May 25, 2015

Page last updated: August 23, 2015

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