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Experience of Using Lipano in Children With Fatty Acid Oxidation Disorders

D

Dr. Schär

Status

Completed

Conditions

Fatty Acid Oxidation Disorder

Treatments

Dietary Supplement: Lipano formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT04400422
Lipano 1 - Case

Details and patient eligibility

About

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

Enrollment

5 patients

Sex

All

Ages

Under 18 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Lipano MCT formula
Experimental group
Description:
Kanso Lipano will be consumed daily for 3 months each to assess tolerability and compliance
Treatment:
Dietary Supplement: Lipano formula

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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