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

NCT ID: NCT03797131

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-06
• Study Completion Date: 2019-09-01

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

KB195 Arm

Group Type: EXPERIMENTAL

KB195 (a novel mixture of oligosaccharides)

Intervention Type: OTHER

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

Interventions

KB195 (a novel mixture of oligosaccharides)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaleido Biosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Wingertzahn

Role: STUDY_DIRECTOR

Kaleido Biosciences

Locations

University Children's Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

K013-118

Identifier Type: -

Identifier Source: org_study_id