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OpenTrials
Completed

NCT Number: NCT02765256

Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) that is refractory to conventional, immunosuppressive therapy.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant is capable of giving informed consent
  • Males or females 18-75 years of age
  • Normal kidney function (defined by normal serum creatinine [male: <1.27 mg/dL; female: <1.03 mg/dL])
  • Normal aspartate aminotransferase [AST] (<41 U/L), alanine aminotransferase [ALT] (<63 U/L), and alkaline phosphatase (<126 U/L)
  • Active CD defined as HBI ≥ 7
  • CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 350 mcg/g (within one month of enrollment)
  • Have been treated with one of the following therapies** for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages.

Exclusion criteria

  • Known or suspected stricturing disease producing obstructive symptoms
  • Active Clostridium difficile infection
  • Unwillingness to provide informed consent
  • Allergy or intolerance to the medications used in this study
  • History of kidney disease
  • History of liver disease
  • Pregnant or lactating females
  • Baseline QTc interval on EKG > 430 in males or > 450 in females
  • Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Treatment and study plan

Fluconazole

Drug

400mg orally once daily (Day 1-14)

Other names: Diflucan

Vancomycin

Drug

500mg oral suspension 4 times daily (Day 1-14)

Other names: Vancocin

Neomycin

Drug

neomycin 1000 mg orally three times daily (Days 1-3)

Other names: Neo-Fradin

Ciprofloxacin

Drug

ciprofloxacin 750 mg orally twice daily (Day 4-14)

Other names: Cipro

Polyethylene glycol 3350

Drug

238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2

Other names: Miralax

Promethazine

Drug

PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).

Other names: Phenergan

Fluconazole placebo

Drug

Once daily

Primary outcomes

  1. Change in Disease Activity by Harvey Bradshaw Index

    Time frame: enrollment visit (baseline) and 15 days

    The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease.

    General Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points

    Abdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points

    Abdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points

    Complications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1

  2. Change in Disease Activity by Fecal Calprotectin (FCP)

    Time frame: enrollment visit (baseline) and 15 days

    The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation.

Secondary outcomes

  1. The Change in High-sensitivity C-reactive Protein (hsCRP)

    Time frame: enrollment visit (baseline) and 15 days

    A secondary outcome measure will be the change in high-sensitivity C-reactive protein between the enrollment visit and day 15. The high-sensitivity C-reactive protein is a blood test which measures systemic inflammation.

  2. Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs).

    Time frame: 105 days

    Number of Medication Side Effects and/or Adverse Events (AEs)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Crohn's and Colitis Foundation

Registry information

Acronym: Holiday

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 6, 2016
Registry last updated
Feb 6, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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