Status:
COMPLETED
Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
University of Pennsylvania
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Crohn Disease
Eligibility:
All Genders
6+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is 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 Cro...
Detailed Description
Investigators will evaluate the efficacy of a novel treatment regimen, employing non-immunosuppressive medications, in the management of refractory CD or IBDU. Refractory patients include those patien...
Eligibility Criteria
Inclusion
- Group 1
- Males or females 6-18 years of age
- Current weight \>10 kg (or 22 lb)
- Ability to swallow pills
- Normal kidney function
- Normal Aspartate transaminase (AST), Alanine transaminase (ALT), and alkaline phosphatase
- Active CD or IBDU defined as PCDAI ≥ 30
- C-Reactive Protein (CRP) ≥ 15mg/L (or 1.5mg/dL) or fecal calprotectin (FCP)\>350mcg/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
- Known allergy or intolerance to aminoglycosides or any of the medications used in this study
- Current use of one or more of the following medications: 5-fluorouracil, digoxin, anticoagulants, theophylline, phenytoin, probenecid, duloxetine, clozapine, sildenafil, hydrochlorothiazide, cyclosporine, hypoglycemics, terfenadine, tacrolimus, rifabutin, midazolam, and voriconazole
- Known diagnosis of diabetes mellitus
- Known or suspected structuring disease producing obstructive symptoms
- Active Clostridium difficile infection
- Prolonged QTc interval as seen on enrollment EKG
- Current use of antibiotics
- Starting or increasing the dose of an IBD related medication within 4 weeks of screening
- Group 2
- Inclusion Criteria
- Males or females 10 years of age and older.
- Patients undergoing a clinical GI endoscopy due to suspicion for active intestinal inflammation determined by physician global assessment (PGA).
- Undergoing a bowel preparation as part of clinical care.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
- Exclusion Criteria
- Antibiotic use within the past 30 days.
- Current presence of an ostomy bag.
- Patients undergoing a non- polyethylene glycol 3350 cleanout.
- Unwillingness to provide informed consent.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Key Trial Info
Start Date :
July 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03476317
Start Date
July 12 2018
End Date
December 31 2020
Last Update
February 9 2022
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146