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

NCT03476317 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-02-09

Study results available
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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 Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.

Conditions

  • Crohn Disease

Interventions

DRUG

Vancomycin

Oral suspension 4 times daily (Day 1-14)

DRUG

Neomycin

Oral three times daily (Days 1-3)

DRUG

Ciprofloxacin

Oral twice daily (Days 4-14)

DRUG

Polyethylene Glycol 3350

Dissolved in Gatorade on day 2

DRUG

Fluconazole

Orally once daily (Day 1-14)

Sponsors & Collaborators

Principal Investigators

  • Lindsey Albenberg, DO · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476317 on ClinicalTrials.gov