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

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ClinicalTrials.gov Identifier: NCT03797131
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kaleido Biosciences

Tracking Information
First Submitted Date  ICMJE December 7, 2018
First Posted Date  ICMJE January 9, 2019
Last Update Posted Date September 4, 2019
Actual Study Start Date  ICMJE January 6, 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03797131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2019)
  • 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
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 4, 2019)
Incidence of adverse events [ Time Frame: Baseline to Day 32 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Urea Cycle Disorders
Intervention  ICMJE Other: KB195 (a novel mixture of oligosaccharides)
KB195 (a novel mixture of oligosaccharides) for oral intake for 21 days.
Study Arms  ICMJE Experimental: KB195 Arm
Intervention: Other: KB195 (a novel mixture of oligosaccharides)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark Wingertzahn (617) 674-9000 info@kaleido.com
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03797131
Other Study ID Numbers  ICMJE K013-118
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaleido Biosciences
Study Sponsor  ICMJE Kaleido Biosciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Wingertzahn Kaleido Biosciences
PRS Account Kaleido Biosciences
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP