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Completed

NCT Number: NCT06035835

Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in 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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lacticaseibacillus rhamnosus

Combination Product

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

Lactobacillus acidophilus + Bifidobacterium bifidum

Combination Product

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

José Uberos Fernández

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2021
Study completion
2022
First posted
Sep 13, 2023
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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