Experience of Using Lipano in Children With Fatty Acid Oxidation Disorders

NCT ID: NCT04400422

Last Updated: 2020-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2018-09-20

Brief Summary

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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

Detailed Description

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Conditions

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Fatty Acid Oxidation Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lipano MCT formula

Kanso Lipano will be consumed daily for 3 months each to assess tolerability and compliance

Group Type EXPERIMENTAL

Lipano formula

Intervention Type 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

Interventions

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Lipano formula

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Schär AG / SPA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Russian Children's Hospital Center for Orphan Diseases

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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Lipano 1 - Case

Identifier Type: -

Identifier Source: org_study_id

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