NCT03476317

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

An Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

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 patients who have experienced loss of responsiveness (LOR) or primary nonresponse to an immunomodulator or a biologic. Investigators will treat participants with a combination of gut microbiota-targeted therapies to restore a healthy gut microbiome composition. Investigators believe that this strategy will both treat the gut inflammation associated with inflammatory bowel disease (IBD) as well as salvage response to immune suppressive therapies. Investigators will also evaluate the effect of PEG lavage alone on fecal calprotectin and gut microbiota. Participants in this arm, will be undergoing a PEG lavage in preparation for a endoscopy for clinical care. They will be asked to provide stool samples, prior to and after their PEG lavage. Participants will not be receiving any investigational treatments.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-07-12
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-03-26
• Last updated: 2022-02-09
• Results posted: 2022-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study