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

NCT03797131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2020-01-10

No results posted yet for this study

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

OTHER

KB195 (a novel mixture of oligosaccharides)

KB195 (a novel mixture of oligosaccharides) for oral intake for 21 days.

Sponsors & Collaborators

  • Kaleido Biosciences

    lead INDUSTRY

Principal Investigators

  • Mark Wingertzahn · Kaleido Biosciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-06
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • Switzerland

Study Locations

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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 NCT03797131 on ClinicalTrials.gov