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Trial record 24 of 61 for:    Neomycin sulfate

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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02765256
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
Lindsey Albenberg, University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Fluconazole Drug: Vancomycin Drug: Neomycin Drug: Ciprofloxacin Drug: Polyethylene Glycol 3350 Drug: Promethazine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Study Start Date : August 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Fluconazole
Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Drug: Fluconazole
400mg orally once daily (Day 1-14)
Other Name: Diflucan

Drug: Vancomycin
500mg oral suspension 4 times daily (Day 1-14)
Other Name: Vancocin

Drug: Neomycin
neomycin 1000 mg orally three times daily (Days 1-3)
Other Name: Neo-Fradin

Drug: Ciprofloxacin
ciprofloxacin 750 mg orally twice daily (Day 4-14)
Other Name: Cipro

Drug: Polyethylene Glycol 3350
238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
Other Name: Miralax

Drug: Promethazine
PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Other Name: Phenergan

Placebo Comparator: Placebo
Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Drug: Vancomycin
500mg oral suspension 4 times daily (Day 1-14)
Other Name: Vancocin

Drug: Neomycin
neomycin 1000 mg orally three times daily (Days 1-3)
Other Name: Neo-Fradin

Drug: Ciprofloxacin
ciprofloxacin 750 mg orally twice daily (Day 4-14)
Other Name: Cipro

Drug: Polyethylene Glycol 3350
238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
Other Name: Miralax

Drug: Promethazine
PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Other Name: Phenergan




Primary Outcome Measures :
  1. Change in disease activity by Harvey Bradshaw Index [ Time Frame: 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 Harvey Bradshaw Index is a clinical score which takes into account general well being, degree of abdominal pain, number of liquid stools per day, abdominal physical examination, and Crohn's disease complications.

  2. Change in disease activity by fecal calprotectin (FCP) [ Time Frame: 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 Outcome Measures :
  1. The change in high-sensitivity C-reactive protein (hsCRP) [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02765256


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
Crohn's and Colitis Foundation
Investigators
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Principal Investigator: Lindsey Albenberg, DO University of Pennsylvania
Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania

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Responsible Party: Lindsey Albenberg, Assistant Professor of Pediatrics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02765256     History of Changes
Other Study ID Numbers: 823635
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

Additional relevant MeSH terms:
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Neomycin
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vancomycin
Ciprofloxacin
Fluconazole
Promethazine
Diphenhydramine
Polyethylene glycol 3350
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antifungal Agents
14-alpha Demethylase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors