Assessment of the Impact of Type of Probiotic Delivery Type and Feeding Type on Baby's Microbiota After Dysbiotic Delivery

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    200
  • sponsor
    Fundacion Clinic per a la Recerca Biomédica
Updated on 10 February 2021

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, single-blinded study with two parallel arms. Group 1 will receive L. reuteri (10^8 CFU) once a day, group 2 will receive B. longum and P. Pentosaceus (10^9 CFU) once a day.

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, etc. On the one hand, vaginally delivered babies are in contact with mother's vaginal and faecal microbiota. This fact will drive a neonatal gut colonization composed of vagina-associated bacteria. In contrast, babies born by C-section are more susceptible to be colonized by microorganisms present in the mother's skin. On the other hand, antibiotic administration during vaginal delivery also produces alterations in the vaginal microbiota of the mother. Described scenarios have been correlated to immunological and metabolic diseases such as asthma, allergies, diabetes or obesity. Moreover, disbiosis has also been associated to functional gastrointestinal disorders (FGID) in babies such as infant colic and functional constipation. After a disbiotic delivery, medical doctors usually recommend the use of probiotics to prevent rebiosis. Since the probiotics.

L. reuteri, and B. longum and P. Pentosaceus have shown efficacy on FGID amelioration in previously published articles, these two probiotics were selected for the present study. All together, this study aims to characterize the role of three different parameters: type of probiotic, delivery type and feeding type.

Details
Condition Dysbiosis
Treatment L. reuteri, B. longum and P. Pentosaceus
Clinical Study IdentifierNCT04304014
SponsorFundacion Clinic per a la Recerca Biomédica
Last Modified on10 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy infants in their first week 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 dose per day - or mixt breastfeeding, the one in which there are more than one formula dose per day

Exclusion Criteria

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
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