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Completed

NCT Number: NCT04400422

Experience of Using Lipano in Children With Fatty Acid Oxidation Disorders

This is a market research, observational study to evaluate the tolerability and acceptability of an MCT based formula for infants and young people with long chain fatty acid oxidation disorder from birth to 18 months. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study

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Key information

Conditions

Fatty Acid Oxidation Disorder

Age range

Up to 18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Russian Children's Hospital Center for Orphan Diseases

Moscow, 117513, Russia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
  • Patients from birth to 18 months
  • Written informed consent obtained from patient or parental caregiver

Exclusion criteria

  • Presence of serious concurrent illness
  • Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
  • Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
  • Any patients having taken antibiotics over the previous 2 weeks leading up to the study
  • Patients over 18 months of age

Treatment and study plan

Lipano formula

Dietary Supplement

Subjects will be asked to take an MCT infant formula to assess the tolerability, compliance and overall acceptability of the product for patient with LCHAD

Primary outcomes

  1. Gastrointestinal tolerance: questionnaire

    Time frame: 90 days

    Daily questionnaire detailing any GI symptoms, severity and change from usual The collection of daily data about the gastrointestinal tolerance of the product

  2. Product compliance

    Time frame: 90 days

    Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.

  3. Product palatability

    Time frame: 90 days

    Questionnaire data captured to evaluate taste

  4. Product acceptability

    Time frame: 90 days

    Brief tick-box questionnaire on overall liking and acceptability of product

Secondary outcomes

  1. Biochemistry stability - creatine kinase

    Time frame: 90 days

    creatine kinase will be monitored

  2. Biochemistry stability - liver enzymes

    Time frame: 90 days

    liver enzymes will be monitored

  3. Anthropometry 1

    Time frame: 90 days

    weight in g monitored to check growth

  4. Anthropometry 2

    Time frame: 90 days

    height in cm monitored to check growth

Sponsors and collaborators

Lead sponsor

Dr. Schär AG / SPA

Industry

Registry information

Official study title

Experience of Using Lipano in Children With LCHAD (Long Chain Fatty Acid Oxidation Disorder)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 22, 2020
Registry last updated
May 22, 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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