Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-31 @ 10:43 AM
Study NCT ID:
NCT05198700
Status:
WITHDRAWN
Last Update Posted:
2023-07-03
First Post:
2021-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Probiotics on Symptoms of Infantile Colic
Sponsor:
Lallemand Health Solutions
Organization:
Study Overview
Official Title:
The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Null recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROCOLIN
Brief Summary:
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.
Detailed Description:
Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.
The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.
The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.
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?: