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Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants

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ClinicalTrials.gov Identifier: NCT06035835
Recruitment Status : Completed
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
José Uberos Fernández, Hospital Clinico Universitario San Cecilio

Study Description
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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
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
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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 : January 1, 2009
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035835


Sponsors and Collaborators
José Uberos Fernández
Investigators
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Principal Investigator: José Uberos-Fernández, Mr Hospital Clinico Universitario San Cecilio
  Study Documents (Full-Text)

Documents provided by José Uberos Fernández, Hospital Clinico Universitario San Cecilio:
Study Protocol and Statistical Analysis Plan  [PDF] August 9, 2023

More Information
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Additional Information:

Publications:

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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: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by José Uberos Fernández, Hospital Clinico Universitario San Cecilio:
Probiotics
Human breastmilk
newborn
very low birth weight
atopic eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases