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Completed

NCT Number: NCT02033408

Manipulating the Microbiome in IBD by Antibiotics and FMT

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.

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Key information

Conditions

Exacerbation of Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Colitis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis, Active Severe

Age range

2 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children (SickKids), Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AB (antibiotics)

Drug
  • 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.

Other names: Ciprofloxacin-Ciprodex®, Doxycycline-Doxylin®, Gentamycin-Gentamicin®, Amoxicillin-Amoxyclav®, Vancomycin-Vanco-Teva®

CS (corticosteroids) Only

Drug
  • 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

Other names: Metronidazole-Flagyl®

Primary outcomes

  1. Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score

    Time frame: at day 5 after treatment (compared between the two treatment groups).

Secondary outcomes

  1. 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.

  2. 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.

  3. The need for second line therapy or colectomy by discharge

    Time frame: by 90 days and at 1 year

  4. 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.

  5. Need for subsequent admission

    Time frame: by 1 year

  6. Calprotectin levels

    Time frame: at 5 and 14 days after treatment.

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

    Time frame: at days 5 and 14 after treatment.

  8. Change in microbiome pattern.

    Time frame: 3 years from baseline

  9. Rate of C. difficile infection

    Time frame: at days 5 and 14 after treatment.

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

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

Acronym: FMT

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Jan 10, 2014
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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