Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT03887169
Eligibility Criteria:
Inclusion Criteria:
* Minor Patient with alveolar proteinosis by double mutation Ala393Thr and SER567LEU of the MARS gene, genetically proven.
* Patient in need of prolonged hospitalization in Necker for treatment of bronchial-alveolar washes in the context of care.
* Patient for which methionine can be administered orally or by enteral probe (Nasogastric or gastrostomy probe)
* Signed Informed consent form by parents / legal guardian
Exclusion Criteria:
* Patient with alveolar proteinosis by other mutations of the MARS gene
* Patient with alveolar proteinosis secondary to another etiology or without identified cause
* Refusal to participate in the study
* High blood pressure requiring drug treatment
* Heart failure
* Known hypersensitivity to one of the substances used or potentially used in the study: methionine, vitamins B6, B12, B9 and C
* Pre-Hypermethioninemia (Methioninemia \> + 2 DS of normal for age) whatever the cause
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03887169
Study Brief:
Protocol Section:
NCT03887169