NCT03797131

Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders

An Open Label Pilot Study to Evaluate the Effect of KB195, a Novel Prebiotic Gluco-Oligosaccharide Mixture, in the Diet of Patients With Urea Cycle Disorders on Gut Nitrogen Metabolism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Kaleido Biosciences · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs). This will be done using a stable isotope to assess nitrogen metabolism in the blood, urine, and stool. The study will also assess the safety and tolerability of KB195 in patients with UCDs.

Conditions

• Urea Cycle Disorders

Interventions

Type	Name	Description
OTHER	KB195 (a novel mixture of oligosaccharides)	KB195 (a novel mixture of oligosaccharides) for oral intake for 21 days.

Timeline

• Start date: 2019-01-06
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2019-01-09
• Last updated: 2020-01-10

Locations

1 site across 1 country: Switzerland