Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants

September 6, 2023 updated by: José Uberos Fernández

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newborn with a gestational age < or = 32 weeks and/or birth weight < or = 1500 grams born at our hospital (Hospital Universitario Clínico San Cecilio, Granada) between January 2009 and December 2021.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change incidence of atopic dermatitis in children receiving probiotics
Time Frame: 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.
From birth to January 2023
To assess whether the combined use of breast milk and probiotics has a beneficial effect on the prevention of atopic dermatitis in children.
Time Frame: 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.
From birth to January 2023
Identify probiotic strains that may decrease the incidence of atopic dermatitis.
Time Frame: 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.
From birth to January 2023
Influence of caloric intake on the development of atopic dermatitis
Time Frame: 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.
From birth to January 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

José Uberos Fernández

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM-2022-12-0144.R2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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