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Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants

J

José Uberos Fernández

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Combination Product: Lactobacillus acidophilus + Bifidobacterium bifidum
Combination Product: Lacticaseibacillus rhamnosus

Study type

Observational

Funder types

Other

Identifiers

NCT06035835
BM-2022-12-0144.R2

Details and patient eligibility

About

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.

Full 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

Enrollment

437 patients

Sex

All

Ages

Under 32 weeks old

Volunteers

No 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.

Trial design

437 participants in 3 patient groups

Probiotic 1
Description:
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
Treatment:
Combination Product: Lacticaseibacillus rhamnosus
Probiotic 2
Description:
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
Treatment:
Combination Product: Lactobacillus acidophilus + Bifidobacterium bifidum
No probiotic
Description:
No suplementation diet with probiotic

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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