Ignite Creation Date:
2025-12-18 @ 8:16 AM
Ignite Modification Date:
2025-12-18 @ 8:16 AM
Study NCT ID:
NCT02405923
Status:
None
Last Update Posted:
2019-07-18 00:00:00
First Post:
2014-11-13 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
Sponsor:
None
Organization:
Study Overview
Official Title:
Clinical Trial Evaluating the Effects on Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula Compared to a Cow's Milk Extensively Hydrolysed Protein Formula in Infants With Cow's Milk Protein Allergy
Status:
None
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment longer than expected and without the expected success
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRITO-14
Brief Summary:
The main purpose of this study is to demonstrate that the rice protein hydrolysed based formula manufactured by Ordesa ensures proper growth and as secondary outcomes, that the formula is devoid of any risk of arsenic or other potential contaminants toxicity and its effect on the duration of CMA (Cow Milk Allergy) from cow's milk protein allergy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: