Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385054
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-23
Brief Title:
Effect of Probiotics on Infantile Colic Symptoms
Sponsor:
Lallemand Health Solutions
Organization:
Lallemand Health Solutions
Study Overview
Official Title:
Effect of Probiotics on Infantile Colic Symptoms a Randomized Double-blind Placebo-controlled Study EPIC
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
EPIC
Brief Summary:
The aim of this clinical trial is to assess the impact of B lactis B94 on participants with infantile colic It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo after 4 weeks of intervention
Detailed Description:
The goal of this clinical trial is to evaluate the potential beneficial effects of B lactis B94 on the symptoms of infantile colic
Participants diagnosed with infantile colic will be recruited to participate in this randomized double-blind placebo controlled two-armed 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 3 in-person visits and 4 phone calls
Participants diagnosed with infantile colic will be recruited to participate in this randomized double-blind placebo controlled two-armed 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 3 in-person visits and 4 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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02612-43 | REGISTRY | None | None |
| PEC23063 | OTHER | Biofortis | None |