Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-03-06 @ 2:55 PM
Study NCT ID:
NCT01721850
Status:
TERMINATED
Last Update Posted:
2022-01-20
First Post:
2012-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
Sponsor:
HiPP GmbH & Co. Vertrieb KG
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial insurance could not be prolonged any more and expired
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Coco
Brief Summary:
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.
Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: