Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants

Sponsor

José Uberos Fernández (Other)

Overall Status

Completed

CT.gov ID

NCT06035835

Collaborator

(none)

437

Enrollment

157.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is assess if the use of probiotic in very low weight could be other benefits a long time, as reduce atopic disease in this children.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Combination Product: Lacticaseibacillus rhamnosus Combination Product: Lactobacillus acidophilus + Bifidobacterium bifidum

Detailed Description

In this study, the investigators analyse the influence of nutrition during the early neonatal period on the development and prevention of atopic dermatitis (AD) in children with a history of very low birth weight (VLBW). A retrospective cohort study was performed of VLBW preterm infants to assess the risk of their developing AD during childhood, according to nutrition with breastmilk and/or probiotic supplementation during the neonatal period. The analysis focused on nutritional and early childhood follow-up data for 437 newborns, of whom 184 received probiotics up to 36 weeks postmenstrual age.

The neonatal history of the patients was consulted in their electronic medical records (gestacional age; birth weight; anthropometry at birth, first week and week 36 post menstrual age; nutricional management; administration of probiotics), and the presence of atopic diseases at school age was corroborated by telephone interviews.

The descriptive date were summarized using medians and interquartile intervals for the continuous variables and distribution frequencies for the categorial variables. Univariate comparisons were made by the Mann-Whitney test for the continuous variables and by the chi-square test for the categorical variables. The association of comorbidities in VLBW newborns and supplementation with one type or another of probiotic was evaluated with a multinomial regression analysis, ajustando por las variables que mostraron diferencias en el análisis de homogeneidad de los grupos de estudio. The analysis was performed using IBM SPSS 20.0 for Windows software

Study Design

Study Type:

Observational

Actual Enrollment :

437 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Probiotics and Breastmilk Are Associated With a Decreased Risk of Atopic Dermatitis in Very Low Birth Weight Premature Infants

Actual Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Probiotic 1 Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age	Combination Product: Lacticaseibacillus rhamnosus Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day)
Probiotic 2 Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age	Combination Product: Lactobacillus acidophilus + Bifidobacterium bifidum Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h)
No probiotic No suplementation diet with probiotic

Arm

Intervention/Treatment

Probiotic 1

Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age

Combination Product: Lacticaseibacillus rhamnosus

Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day)

Probiotic 2

Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h) in very low birth weight since start at the first enteral feed until 35 week Postmenstrual age

Combination Product: Lactobacillus acidophilus + Bifidobacterium bifidum

Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h)

No probiotic

No suplementation diet with probiotic

Outcome Measures

Primary Outcome Measures

Change incidence of atopic dermatitis in children receiving probiotics [From birth to January 2023]
The investigators will assess the presence of atopic dermatitis (itching and chronic or recurrent eczematous lesions with typical morphology and distribution) in the telephone interview.
To assess whether the combined use of breast milk and probiotics has a beneficial effect on the prevention of atopic dermatitis in children. [From birth to January 2023]
The investigators will ask patients for both attopic dermatitis involvement and a history of probiotic and breast milk administration in the neonatal period.
Identify probiotic strains that may decrease the incidence of atopic dermatitis. [From birth to January 2023]
In the group of patients who received probiotics we found two groups, one group received Lacticaseibacillus rhamnosus ATCC 53103 and the other group received the combination of Lactobacillus acidophilus ATCC 4356 + Bifidobacterium bifidum ATCC 15696. An attempt will be made to identify if there are differences between them.
Influence of caloric intake on the development of atopic dermatitis [From birth to January 2023]
The researchers will look at the medical history for caloric and macronutrient intake during the first weeks of life and assess whether it is related to differences in the development of atopic dermatitis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 32 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newborn with a gestational age < or = 32 weeks and/or birth weight < or = 1500 grams.

Exclusion Criteria:

Incomplete health history record o lack of data.
Severe congenital anomalies.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

José Uberos Fernández

Investigators

Principal Investigator: José Uberos-Fernández, Mr, Hospital Clinico Universitario San Cecilio

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Aug 9, 2023

More Information

Additional Information:

Uberos, J., Narbona, E., Gormaz, M., Lines, M., Rodríguez, G., Saenz de Pipaón, M. and Couce, M., 2017b. Nutrición parenteral en el recién nacido prematuro de muy bajo peso. Propuesta de un protocolo de actuación tras revisión de la evidencia científica.

Publications

Responsible Party:

José Uberos Fernández, Head of Unit Care Neonatology, Principal Investigator, Clinical Professor, Hospital Clinico Universitario San Cecilio

ClinicalTrials.gov Identifier:

NCT06035835

Other Study ID Numbers:

BM-2022-12-0144.R2

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by José Uberos Fernández, Head of Unit Care Neonatology, Principal Investigator, Clinical Professor, Hospital Clinico Universitario San Cecilio

Probiotics

Human breastmilk

newborn

very low birth weight

atopic eczema

Additional relevant MeSH terms:

Dermatitis, Atopic

Dermatitis

Eczema

Study Results

No Results Posted as of Sep 13, 2023