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

Kaleido Biosciences

Status

Completed

Conditions

Urea Cycle Disorders

Treatments

Other: KB195 (a novel mixture of oligosaccharides)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03797131

K013-118

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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