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

Fundacion Clinic per a la Recerca Biomédica120 enrolled

Overview

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. The total duration of intervention will be 3 months.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Dysbiosis

Interventions

L. reuteriDIETARY_SUPPLEMENT

(10\^8 CFU) once a day for 3 months

B. longum and P. PentosaceusDIETARY_SUPPLEMENT

(10\^9 CFU) once a day for 3 months

Eligibility

Sex: ALLMax age: 25 Days

Medical Language ↔ Plain English

Inclusion Criteria: * 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 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.

Locations (3)

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Fundación HM Hospitales (Hospital HM Puerta Sur)

Madrid, Madrid, Spain

Neonatal Unit, Hospital Clinic-Maternitat

Barcelona, Spain

Outcomes

Primary Outcomes

Relative abundance of bifidobacteria

Changes in the relative abundance of bifidobacteria in stool microbiota after 1 month of supplementation, measured with metagenomic techniques.

Time frame: 1 month

Secondary Outcomes

Number of regurgitations by questionnaire included in patients' diary

Number of regurgitations will be documented by the parents each week for 3 months in patients diary

Time frame: 3 months

Number of constipation episodes by questionnaire included in patients' diary

Number of constipation episodes will be documented by the parents each week for 3 months in patients' diary

Time frame: 3 months

Number of infant colic episodes by questionnaire included in patients' diary

Number of constipation episodes will be documented by the parents each week for 3 months in patient's diary

Time frame: 3 months

Metagenomic analysis of total gut microbiota

This measure includes all bacteria detected in feaces by metagenomic analysis. Faecal samples will be collected at baseline and 1 month after probiotic treatment. Analysis will comprise changes in the relative abundance of B. longum and P. Pentosaceous as well as in other bacterial groups common in the infant gut. In addition, the proportion (Bifidobacterium + Lactobacillus + Bacteroides) will be determined

Time frame: 1 month

Respiratory, gastrointestinal infections and use of medication by questionnaire included in patients' diary

Number of respiratory, gastrointestinal infections and use of medication episodes will be documented by the parents each week for 3 months in patient's diary

Data from ClinicalTrials.gov

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