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Completed

NCT Number: NCT03797131

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

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.

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Key information

Conditions

Urea Cycle Disorders Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Urea Cycle Disorders, Inborn

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Zurich

Zurich, CH-8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KB195 (a novel mixture of oligosaccharides)

Other

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

Primary outcomes

  1. Change in labelled (15N-nitrogen) and total nitrogen excretion in urine

    Time frame: Baseline to Day 25

    Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-nitrogen) and total nitrogen excretion in urine

  2. Change in labelled (15N-urea) and total urea excretion in urine

    Time frame: Baseline to Day 25

    Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-urea) and total urea excretion in urine

  3. Change in labelled (15N-ammonia) and total ammonia excretion in urine

    Time frame: Baseline to Day 25

    Evaluate the effect of KB195 on nitrogen metabolism in the gut of patients with UCD by analyzing the change in labelled (15N-ammonia) and total ammonia excretion in urine

Secondary outcomes

  1. Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires

    Time frame: Baseline to Day 32

    Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions

  2. Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires

    Time frame: Baseline to Day 32

    Evaluate the effect of KB195 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid).

Other outcomes

  1. Incidence of adverse events

    Time frame: Baseline to Day 32

Sponsors and collaborators

Lead sponsor

Kaleido Biosciences

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2019
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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