Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631937
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Human Milk Oligosaccharides on Infant Gut Microbiota Modulation Development of the Immune System and Health Later in Life The BELIEF Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BELIEF
Brief Summary:
The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota the immune maturation and how the interaction between the microbiota and immune maturation may impact both short and long term health of the infant
The participants will
Consume the investigational products activeplacebo for 6 months
Legal guardiansparents to the participant to collect stool samples from the diapers at home
Legal guardiansparents to the participant to report gastrointestinal symptoms signs of infections in an electronic questionnaire
Visit the clinic for checkups and dried blood sample collection
For reference a group of breastfed infants will be included They will undergo the same procedures apart from consuming the investigational product activeplacebo 230 participants 115 in each intervention arm will be randomized to an intervention and 104 participants will be recruited for the reference group giving a total sample size of 334 participants
The intervention trial will be reported in two steps first step covering the intervention phase from birth to 6 months and step two includes both the intervention phase 0-6 months and the follow-up period from 6-12 months Informed consents for the possibility to preform long-term follow-up will be obtained
The participants will
Consume the investigational products activeplacebo for 6 months
Legal guardiansparents to the participant to collect stool samples from the diapers at home
Legal guardiansparents to the participant to report gastrointestinal symptoms signs of infections in an electronic questionnaire
Visit the clinic for checkups and dried blood sample collection
For reference a group of breastfed infants will be included They will undergo the same procedures apart from consuming the investigational product activeplacebo 230 participants 115 in each intervention arm will be randomized to an intervention and 104 participants will be recruited for the reference group giving a total sample size of 334 participants
The intervention trial will be reported in two steps first step covering the intervention phase from birth to 6 months and step two includes both the intervention phase 0-6 months and the follow-up period from 6-12 months Informed consents for the possibility to preform long-term follow-up will be obtained
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None