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

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.

Conditions

• Crohn's Disease

Interventions

DRUG

Fluconazole

400mg orally once daily (Day 1-14)

DRUG

Vancomycin

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

DRUG

Neomycin

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

DRUG

Ciprofloxacin

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

DRUG

Polyethylene Glycol 3350

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

DRUG

Promethazine

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

DRUG

Fluconazole placebo

Once daily

Sponsors & Collaborators

• Children's Hospital of Philadelphia

  collaborator OTHER

• Crohn's and Colitis Foundation

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Lindsey Albenberg, DO · University of Pennsylvania

• James D Lewis, MD, MSCE · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• United States

Study Locations