Modulation of Bifidocentric Dysbiosis Through Bifidobacterium Bifidum PRL2010 Supplementation in Caesarian-born Infants
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is aimed to manipulate the composition of the intestinal flora of the infants born by caesarian section through the administration of the probiotic strain "Bifidobacterium bifidum PRL 2010", in order to evaluate its effects on gut dysbiosis during the first 6 month of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2021
CompletedFirst Submitted
Initial submission to the registry
May 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedJuly 7, 2023
July 1, 2023
1.3 years
May 30, 2023
July 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with disease
Number of participants with skin, respiratory and gastrointestinal diseases assessed with a questionnaire submitted to parents
up to 6 months
Secondary Outcomes (1)
Variation in children gut microbiota composition
up to 6 months
Study Arms (2)
Probiotic Bifidobacterium Bifidum PRL2010
EXPERIMENTALParticipants in this group will receive probiotic Bifidobacterium Bifidum PRL2010 supplementation from the time of discharge to a daily for the 6 months
Control
ACTIVE COMPARATORParticipants in this group will not receive probiotic probiotic supplementation
Interventions
Probiotic supplement
Eligibility Criteria
You may qualify if:
- Healthy infants born by caesarian delivery
- Parents informed written consent
You may not qualify if:
- Suspension of the administration of the probiotic strain for a period of time exceeding 7 days
- Interruption of the administration of the probiotic strain before the completion of the sixth month
- Replacement of Bifidobacterium bifidum PRL2010 with another strain
- Refusal to collect the fecal sample expressed by parents
- Major congenital birth deformities
- Acute illness at enrollment
- Any condition affecting food intake or metabolism
- Maternal mental and psychosomatic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neonatology and Neonatal Intensive Care Unit of Santa Maria Goretti Hospital
Latina, LT 04100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Biochemistry and Experimental Medicine
Study Record Dates
First Submitted
May 30, 2023
First Posted
July 7, 2023
Study Start
January 5, 2020
Primary Completion
May 2, 2021
Study Completion
May 25, 2021
Last Updated
July 7, 2023
Record last verified: 2023-07