Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666324
Status:
UNKNOWN
Last Update Posted:
2020-12-14
First Post:
2020-12-07
Brief Title:
Effects of Multilac Baby on Fecal Calprotectin Levels of Colicky Babies
Sponsor:
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Organization:
The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Study Overview
Official Title:
Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open trial with two parallel arms assessing the effects of Simethicone and Multilac Baby on crying behavior and fecal calprotectin levels in babies diagnosed for infantile colic
Detailed Description:
Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessels criteria Study design will be open label with two parallel arms Simethicone and Multilac Baby Multilac Baby is a synbiotic product containing probiotic bacteria six lactobacilli and 3 bifidobacteria Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries Fecal calprotectin values at the beginning and at the end of the study will be evaluated using BÜHLMANN Quantum Blue Calprotectin High Range Schönenbuch Switzerland a quantitative immunoassay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None