Atopic DermatitisNCT06035835
Probiotics and Breastmilk Decrease Risk of Atopic Dermatitis in Premature Infants
An observational study of Atopic Dermatitis, run by José Uberos Fernández.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Lacticaseibacillus rhamnosus and Lactobacillus acidophilus + Bifidobacterium bifidum
- How many people
- 437 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Newborn with a gestational age < or = 32 weeks and/or birth weight < or = 1500 grams.
Who cannot join
- Incomplete health history record o lack of data.
- Severe congenital anomalies.
About this study
Official title: 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.
Read the 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
- Conditions
- Atopic Dermatitis
- Being tested
- Lacticaseibacillus rhamnosus, Lactobacillus acidophilus + Bifidobacterium bifidum
- Keywords
- Probiotics, Human breastmilk, newborn, very low birth weight, atopic eczema
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacticaseibacillus rhamnosusCombination product
Administration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day)
Lactobacillus acidophilus + Bifidobacterium bifidumCombination product
Administration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: Lacticaseibacillus rhamnosus | |
| 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 Receives: Combination Product: Lactobacillus acidophilus + Bifidobacterium bifidum | |
| No probiotic | No suplementation diet with probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change incidence of atopic dermatitis in children receiving probiotics
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.
Measured: 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.
The investigators will ask patients for both attopic dermatitis involvement and a history of probiotic and breast milk administration in the neonatal period.
Measured: From birth to January 2023
Identify probiotic strains that may decrease the incidence of atopic dermatitis.
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.
Measured: From birth to January 2023
Influence of caloric intake on the development of atopic dermatitis
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.
Measured: From birth to January 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jan 2009
- Primary completion31 Dec 2021
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Uberos Fernández
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, José Uberos Fernández, Hospital Clinico Universitario San Cecilio
- Investigators
- José Uberos-Fernández, Mr, Principal investigator, Hospital Clinico Universitario San Cecilio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035835
- Sponsor's protocol ID
- BM-2022-12-0144.R2
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Altobelli E, Angeletti PM, Verrotti A, Petrocelli R. The Impact of Human Milk on Necrotizing Enterocolitis: A Systematic Review and Meta-Analysis. Nutrients. 2020 May 6;12(5):1322. doi: 10.3390/nu12051322.
PubMed 32384652Bjorkander S, Carvalho-Queiroz C, Hallberg J, Persson JO, Johansson MA, Nussbaum B, Jenmalm MC, Nilsson C, Sverremark-Ekstrom E. Childhood allergy is preceded by an absence of gut lactobacilli species and higher levels of atopy-related plasma chemokines. Clin Exp Immunol. 2020 Dec;202(3):288-299. doi: 10.1111/cei.13494. Epub 2020 Aug 5.
PubMed 32652542Campos-Martinez AM, Exposito-Herrera J, Gonzalez-Bolivar M, Fernandez-Marin E, Uberos J. Evaluation of Risk and Preventive Factors for Necrotizing Enterocolitis in Premature Newborns. A Systematic Review of the Literature. Front Pediatr. 2022 May 17;10:874976. doi: 10.3389/fped.2022.874976. eCollection 2022.
PubMed 35656377Cukrowska B, Ceregra A, Maciorkowska E, Surowska B, Zegadlo-Mylik MA, Konopka E, Trojanowska I, Zakrzewska M, Bierla JB, Zakrzewski M, Kanarek E, Motyl I. The Effectiveness of Probiotic Lactobacillus rhamnosus and Lactobacillus casei Strains in Children with Atopic Dermatitis and Cow's Milk Protein Allergy: A Multicenter, Randomized, Double Blind, Placebo Controlled Study. Nutrients. 2021 Apr 1;13(4):1169. doi: 10.3390/nu13041169.
PubMed 33916192Cuna A, Morowitz MJ, Ahmed I, Umar S, Sampath V. Dynamics of the preterm gut microbiome in health and disease. Am J Physiol Gastrointest Liver Physiol. 2021 Apr 1;320(4):G411-G419. doi: 10.1152/ajpgi.00399.2020. Epub 2021 Jan 13.
PubMed 33439103Damm JA, Smith B, Greisen G, Krogfelt KA, Clausen ML, Agner T. The influence of probiotics for preterm neonates on the incidence of atopic dermatitis-results from a historically controlled cohort study. Arch Dermatol Res. 2017 May;309(4):259-264. doi: 10.1007/s00403-017-1725-4. Epub 2017 Mar 7.
PubMed 28271213David TJ, Ewing CI. Atopic eczema and preterm birth. Arch Dis Child. 1988 Apr;63(4):435-6. doi: 10.1136/adc.63.4.435.
PubMed 3365015Fanfaret IS, Boda D, Ion LM, Hosseyni D, Leru P, Ali S, Corcea S, Bumbacea R. Probiotics and prebiotics in atopic dermatitis: Pros and cons (Review). Exp Ther Med. 2021 Dec;22(6):1376. doi: 10.3892/etm.2021.10811. Epub 2021 Sep 28.
PubMed 34650624Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.
PubMed 23601190Fijan S, Kolc N, Hrasovec M, Jamtvedt G, Pogacar MS, Micetic Turk D, Maver U. Single-Strain Probiotic Lactobacilli for the Treatment of Atopic Dermatitis in Children: A Systematic Review and Meta-Analysis. Pharmaceutics. 2023 Apr 17;15(4):1256. doi: 10.3390/pharmaceutics15041256.
PubMed 37111741Fuleihan RL. The hygiene hypothesis and atopic disease. Curr Opin Pediatr. 2002 Dec;14(6):676-7. doi: 10.1097/00008480-200212000-00004. No abstract available.
PubMed 12436033Gdalevich M, Mimouni D, David M, Mimouni M. Breast-feeding and the onset of atopic dermatitis in childhood: a systematic review and meta-analysis of prospective studies. J Am Acad Dermatol. 2001 Oct;45(4):520-7. doi: 10.1067/mjd.2001.114741.
PubMed 11568741Hahn WH, Kim J, Song S, Park S, Kang NM. The human milk oligosaccharides are not affected by pasteurization and freeze-drying. J Matern Fetal Neonatal Med. 2019 Mar;32(6):985-991. doi: 10.1080/14767058.2017.1397122. Epub 2017 Nov 6.
PubMed 29108433Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
PubMed 11297958Levine TA, Grunau RE, McAuliffe FM, Pinnamaneni R, Foran A, Alderdice FA. Early childhood neurodevelopment after intrauterine growth restriction: a systematic review. Pediatrics. 2015 Jan;135(1):126-41. doi: 10.1542/peds.2014-1143.
PubMed 25548332
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Breastmilk Are Associated With a Decreased Risk of Atopic Dermatitis in Very Low Birth Weight Premature Infants
- ClinicalTrials.gov ID
- NCT06035835
- Acronym / sponsor ID
- BM-2022-12-0144.R2
- Conditions
- Atopic Dermatitis
- Keywords
- Probiotics, Human breastmilk, newborn, very low birth weight, atopic eczema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- José Uberos FernándezUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic 1 | – | Combination Product: Lacticaseibacillus rhamnosusAdministration 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 |
| Probiotic 2 | – | Combination Product: Lactobacillus acidophilus + Bifidobacterium bifidumAdministration 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 |
| No probiotic | – | –No suplementation diet with probiotic |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Newborn with a gestational age < or = 32 weeks and/or birth weight < or = 1500 grams.
Key exclusion criteria (2 listed)
- Incomplete health history record o lack of data.
- Severe congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacticaseibacillus rhamnosusAdministration Lacticaseibacillus rhamnosus (L. Rhamnosus) ATCC 53103 (109 UFC/day) | Combination product | Probiotic 1 |
| Lactobacillus acidophilus + Bifidobacterium bifidumAdministration Lactobacillus acidophilus (L. acidophilus) ATCC 4356 (109 UFC/12 h)+Bifidobacterium bifidum (B. bifidum) ATCC 15696 (109 UFC/12 h) | Combination product | Probiotic 2 |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 32384652Altobelli E, Angeletti PM, Verrotti A, Petrocelli R. The Impact of Human Milk on Necrotizing Enterocolitis: A Systematic Review and Meta-Analysis. Nutrients. 2020 May 6;12(5):1322. doi: 10.3390/nu12051322.
- Background: PubMed 32652542Bjorkander S, Carvalho-Queiroz C, Hallberg J, Persson JO, Johansson MA, Nussbaum B, Jenmalm MC, Nilsson C, Sverremark-Ekstrom E. Childhood allergy is preceded by an absence of gut lactobacilli species and higher levels of atopy-related plasma chemokines. Clin Exp Immunol. 2020 Dec;202(3):288-299. doi: 10.1111/cei.13494. Epub 2020 Aug 5.
- Background: PubMed 35656377Campos-Martinez AM, Exposito-Herrera J, Gonzalez-Bolivar M, Fernandez-Marin E, Uberos J. Evaluation of Risk and Preventive Factors for Necrotizing Enterocolitis in Premature Newborns. A Systematic Review of the Literature. Front Pediatr. 2022 May 17;10:874976. doi: 10.3389/fped.2022.874976. eCollection 2022.
- Background: PubMed 33916192Cukrowska B, Ceregra A, Maciorkowska E, Surowska B, Zegadlo-Mylik MA, Konopka E, Trojanowska I, Zakrzewska M, Bierla JB, Zakrzewski M, Kanarek E, Motyl I. The Effectiveness of Probiotic Lactobacillus rhamnosus and Lactobacillus casei Strains in Children with Atopic Dermatitis and Cow's Milk Protein Allergy: A Multicenter, Randomized, Double Blind, Placebo Controlled Study. Nutrients. 2021 Apr 1;13(4):1169. doi: 10.3390/nu13041169.
- Background: PubMed 33439103Cuna A, Morowitz MJ, Ahmed I, Umar S, Sampath V. Dynamics of the preterm gut microbiome in health and disease. Am J Physiol Gastrointest Liver Physiol. 2021 Apr 1;320(4):G411-G419. doi: 10.1152/ajpgi.00399.2020. Epub 2021 Jan 13.
- Background: PubMed 28271213Damm JA, Smith B, Greisen G, Krogfelt KA, Clausen ML, Agner T. The influence of probiotics for preterm neonates on the incidence of atopic dermatitis-results from a historically controlled cohort study. Arch Dermatol Res. 2017 May;309(4):259-264. doi: 10.1007/s00403-017-1725-4. Epub 2017 Mar 7.
- Background: PubMed 3365015David TJ, Ewing CI. Atopic eczema and preterm birth. Arch Dis Child. 1988 Apr;63(4):435-6. doi: 10.1136/adc.63.4.435.
- Background: PubMed 34650624Fanfaret IS, Boda D, Ion LM, Hosseyni D, Leru P, Ali S, Corcea S, Bumbacea R. Probiotics and prebiotics in atopic dermatitis: Pros and cons (Review). Exp Ther Med. 2021 Dec;22(6):1376. doi: 10.3892/etm.2021.10811. Epub 2021 Sep 28.
- Background: PubMed 23601190Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.
- Background: PubMed 37111741Fijan S, Kolc N, Hrasovec M, Jamtvedt G, Pogacar MS, Micetic Turk D, Maver U. Single-Strain Probiotic Lactobacilli for the Treatment of Atopic Dermatitis in Children: A Systematic Review and Meta-Analysis. Pharmaceutics. 2023 Apr 17;15(4):1256. doi: 10.3390/pharmaceutics15041256.
- Background: PubMed 12436033Fuleihan RL. The hygiene hypothesis and atopic disease. Curr Opin Pediatr. 2002 Dec;14(6):676-7. doi: 10.1097/00008480-200212000-00004. No abstract available.
- Background: PubMed 11568741Gdalevich M, Mimouni D, David M, Mimouni M. Breast-feeding and the onset of atopic dermatitis in childhood: a systematic review and meta-analysis of prospective studies. J Am Acad Dermatol. 2001 Oct;45(4):520-7. doi: 10.1067/mjd.2001.114741.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Uberos-Fernández, Mr principal investigator
Hospital Clinico Universitario San Cecilio
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by José Uberos Fernández.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change incidence of atopic dermatitis in children receiving probiotics (time frame: From birth to January 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035835, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.