Oral Vancomycin for Biliary Atresia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Biliary Atresia+1 MoreOral Vancomycin - Drug
Eligibility
2 - 40
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of vancomycin on biliary atresia and primary sclerosing cholangitis. It will also study the microbiome of the intestine and its interactions with the human host.

Eligible Conditions
  • Primary Sclerosing Cholangitis
  • Biliary Atresia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 months

3 months
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia

Trial Safety

Safety Progress

1 of 3

Side Effects for

Oral Vancomycin
25%Abdominal pain
13%Syncope, altered mental status
13%Volume overload
13%Hypoxemia
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT03388268) in the Oral Vancomycin ARM group. Side effects include: Abdominal pain with 25%, Syncope, altered mental status with 13%, Volume overload with 13%, Hypoxemia with 13%.

Trial Design

1 Treatment Group

Oral Vancomycin
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Oral Vancomycin · No Placebo Group · Phase 1

Oral Vancomycin
Drug
Experimental Group · 1 Intervention: Oral Vancomycin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

Sacramento Pediatric GastroenterologyLead Sponsor
Yinka Davies, M.D.Principal InvestigatorSacramento Pediatric Gastroenterology

Eligibility Criteria

Age 2 - 40 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder, or are having upper or lower endoscopies.
People with primary sclerosing cholangitis or biliary atresia who are likely to respond well to vancomycin therapy.