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

NCT04304014 | Completed

• 1 other identifier: Pro-Care 3
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 3

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, 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.

Conditions

Dysbiosis

Keywords

probiotic; microbiota; newborn

Outcome Measures

Primary Outcomes (1)

• Relative abundance of bifidobacteria

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

  1 month

Secondary Outcomes (10)

• Number of regurgitations by questionnaire included in patients' diary

  3 months

• Number of constipation episodes by questionnaire included in patients' diary

  3 months

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

  3 months

• Metagenomic analysis of total gut microbiota

  1 month

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

  3 months

Study Arms (2)

L. reuteri

EXPERIMENTAL

Group that will receive L. reuteri one dose per day in an oral suspension Intervention: Dietary Supplement: L. reuteri

Dietary Supplement: L. reuteri

B. longum and P. Pentosaceus

EXPERIMENTAL

Group that will receive B. longum and P. Pentosaceus one dose per day in an oral suspension. Intervention: Dietary Supplement: B. longum and P. Pentosaceus

Interventions

L. reuteri DIETARY_SUPPLEMENT

(10\^8 CFU) once a day

L. reuteri

B. longum and P. Pentosaceus DIETARY_SUPPLEMENT

(10\^9 CFU) once a day

Eligibility Criteria

• Age: Up to 25 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (3)

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Fundación HM Hospitales (Hospital HM Puerta Sur)

Madrid, Madrid, 28938, Spain

Location

Neonatal Unit, Hospital Clinic-Maternitat

Barcelona, Spain

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both probiotic products will be provided in their commercial form. Both products will be individually placed inside opaque bags so that the investigator can not recognize the external case.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 11, 2020
• Study Start: March 5, 2020
• Primary Completion: March 12, 2024
• Study Completion: November 30, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

ES (3)