Status:
COMPLETED
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
Lead Sponsor:
Kaleido Biosciences
Conditions:
Urea Cycle Disorders
Eligibility:
All Genders
14+ years
Phase:
NA
Brief 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 wi...
Eligibility Criteria
Inclusion
- Confirmed UCD patient at any age ≥ 14 years
- Parental/legal guardian permission or patient's written informed consent or assent, as applicable
- Be willing and able to comply with study requirements
Exclusion
- Any medical condition unrelated to the sequelae of UCD
- Patient has N-acetylglutamate synthase (NAGS) deficiency
- Recent hospitalization or risk for metabolic decompensation
- Liver transplantation
- Systemic antibiotics, probiotics or prebiotics that do not align with study guidances
- Change in dose or frequency of any drug or other compound to modulate GI motility
- Contraindications or known allergy/sensitivity to the use of the study products
- Use of an investigational drug, product or device within 30 days prior to Screening Visit, or current enrolment in another investigational drug, product, or device study
- Considered to be at risk for noncompliance or unlikely for any reason to be able to comply with the study procedures
Key Trial Info
Start Date :
January 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03797131
Start Date
January 6 2019
End Date
September 1 2019
Last Update
January 10 2020
Active Locations (1)
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1
University Children's Hospital Zurich
Zurich, Switzerland, CH-8032