Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452199
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-22
Brief Title:
The BEGIN Study Bifidobacterium Infantis to Newborns Effects of Modulating the Gut Microbial Composition on Growth Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
The BEGIN Study Bifidobacterium Infantis to Newborns Effects of Modulating the Gut Microbial Composition on Growth Immune Function and Inflammatory Conditions
Status:
RECRUITING
Status Verified Date:
2024-04
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:
BEGIN
Brief Summary:
The goal of The BEGIN Study a randomized controlled double-blinded intervention trial is to learn if probiotics with Bifidobacterium longum subspecies infantis Bifin02 B infantis given to healthy newborns can affect various health outcomes and to explore impacts of the infant gastrointestinal microbiome The main questions it aims to answer are
Does B infantis probiotics impact immune function and does it lower the number of bacterial infections and use of antibiotics
Does B infantis probiotics impact overall health development growth and wellbeing
Does B infantis probiotics impact inflammatory diseases allergies and autoimmune diseases
Researchers will compare B infantis probiotics to a placebo a look-alike substance that contains no probiotic to see if B infantis colonization impact the human immunesystem and various clinical and biochemical health markers
Participants parents will
Orally administrate the B infantis probiotic to their newborn child daily in three weeks from 7 days of age
Answer baseline and follow up questionnaires in a study app
Take five stool samples from the child and one stool sample from the mother
Collect a 4 week of passive dust sample at home Electrostatic Dust fall Collector
Donate one dried bloodspot and one blood sample from their child
Does B infantis probiotics impact immune function and does it lower the number of bacterial infections and use of antibiotics
Does B infantis probiotics impact overall health development growth and wellbeing
Does B infantis probiotics impact inflammatory diseases allergies and autoimmune diseases
Researchers will compare B infantis probiotics to a placebo a look-alike substance that contains no probiotic to see if B infantis colonization impact the human immunesystem and various clinical and biochemical health markers
Participants parents will
Orally administrate the B infantis probiotic to their newborn child daily in three weeks from 7 days of age
Answer baseline and follow up questionnaires in a study app
Take five stool samples from the child and one stool sample from the mother
Collect a 4 week of passive dust sample at home Electrostatic Dust fall Collector
Donate one dried bloodspot and one blood sample from their child
Detailed Description:
None
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