Status:
COMPLETED
Assessment of the Impact of Type of Probiotic, Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Dysbiosis
Eligibility:
All Genders
Up to 25 years
Phase:
NA
Brief Summary
This study aims to determine the effect of three factors (delivery type, feeding type and the use of two different dietary supplements) on rebiosis after disbiotic delivery. This is a randomized, sing...
Detailed Description
Gut colonization during the first days of life represents the start of the infant's own microbiota. This process is influenced by different factors: delivery type, feeding type, antibiotic treatment, ...
Eligibility Criteria
Inclusion
- Healthy infants up to 25 days of life
- Infants with adequate weight according to the gestational age.
- Infants born by vaginal delivery whose mother was given antimicrobial prophylaxis or infants born by C-section.
- Gestational birth equal or greater than 37 weeks.
- Exclusive or almost exclusive breastfeeding (understanding almost exclusive the one in which there is a maximum of one formula feeding per day) or mixed feeding (in which there is more than one formula feeding per day).
Exclusion
- Infants with smoker mother during pregnancy and after delivery.
- Infants whose parents cannot follow the study requirements
- Infants who have suffered neonatal admission or have suffered or suffer necrotizing enterocolitis, infectious disease, congenital malformation, short bowel syndrome or any serious illness.
- Infants who have taken probiotics before the start of the trial or who take formula with probiotics.
- Breast-fed infants whose mothers have taken probiotics within the two weeks before study inclusion.
- Infants who ingest special formulas as extensively hydrolysed formulas.
- Breast-fed infants whose mothers have excluded dairy products and egg products in their diet during breastfeeding
- Infants who take specific medication for the treatment of functional digestive disorders: antacids (type IBP or H2 blockers), laxatives (PEG, lactulose, magnesia), lactase and simethicone at the time of inclusion.
- Infants undergoing therapies with acupuncture, homeopathy, medicinal herbs, anti-inflammatories and antispasmodics at the time of inclusion.
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT04304014
Start Date
March 5 2020
End Date
November 30 2024
Last Update
May 20 2025
Active Locations (3)
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1
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
2
Fundación HM Hospitales (Hospital HM Puerta Sur)
Madrid, Madrid, Spain, 28938
3
Neonatal Unit, Hospital Clinic-Maternitat
Barcelona, Spain