Mother - Newborn Observational Study

Skin Microbiome Clinical Trial

Official title:

Skin Structure, Skin Function and Skin Microbiome of Pregnant Females and Their Newborns: a Descriptive Longitudinal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759924
• Other study ID #: CRC-SP-AC-38
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pregnancy leads to a number of skin changes but empirical evidence about the structural and functional changes of the skin is scarce. Findings on skin structure and function in newborns and children in the first year of life reveal a rapid skin maturation after birth, but evidence indicates, that in particular water-holding and transport mechanisms are very different to adults in the first year in life. The most important open question is whether and how the maternal cutaneous properties predict the skin function of their children. This is especially relevant for the skin microbiome, because it closely interacts with the host and is assumed to play a role in many skin diseases. Therefore, the objective of this study is the description of characteristics of skin and hair structure and skin function of pregnant women and their newborns during pregnancy and for both in the first six months after delivery. In addition, we investigate associations of the mother's and their newborns skin microbiomes, and changes thereof in the newborns within the first six months of life.

The study has a descriptive, exploratory, longitudinal design. We will recruit pregnant females between 18 to 45 years old using advertisement campaigns, study information material in the waiting areas of their gynecologists, in pregnancy preparation services and in hospital's outpatient services. If they are interested and fulfill the inclusion criteria, they are invited to participate. Taking into account an assumed dropout rate of about 30%, a final sample of n = 100 women is expected. A detailed dermatological examination and general medical condition are documented. Non-invasive, standardized skin and hair physiological and skin microbiome measurements are performed during the visits. Baseline is scheduled during pregnancy until late 4 weeks before delivery. Follow-up visits are scheduled 4 weeks and 6 months after birth for mothers and newborns. Descriptive statistical methods will be calculated for frequencies and associations over time depending on scale levels of the measurements.

In our longitudinal study, we will characterize a broad range of individual and environmental characteristics of mothers and their newborns to evaluate interrelationships with skin parameters and their changes over the period of at least 8 months. Considering these multiple variables and levels together will allow a deeper understanding of the complex interrelationship of the newborns skin maturation.

Description:

A longitudinal descriptive, exploratory cohort study will be performed including females during pregnancy, puerperium and their newborns until sixth months of life.

Women will be invited after the first pregnancy trimester from the federal state of Berlin (Germany) during their visits to gynecologists and/or midwives. Inclusion and all study visits and measurement procedures will be conducted at the Clinical Research Center for Hair and Skin Science at the Department of Dermatology at the Charité-Universitätsmedizin Berlin (Germany). If meeting the eligibility criteria women will be included into the study. After inclusion into the study during the baseline visit, women will be followed at date of delivery + four weeks and followed further at the sixth month after delivery. The newborn/infants will be examined up to four weeks after birth and will be followed at sixth month after birth.

Due to the descriptive and exploratory nature of this study a broad range of characteristics and variables will be measured. Main aspects are skin structure, skin function and skin microbiome in one skin area. Skin structure will be measured by means of skin surface topography, epidermal thickness, skin stiffness and elasticity. Skin function will be measured by means of stratum corneum hydratation (SCH), TEWL and skin surface pH, which are established parameters to characterize the skin barrier function. Skin microbiome is defined as bacterial diversity, in detail the relative abundance of phylotypes, operational taxonomic units (OTU) will be measured. Hair growth will be measured on central and occipital scalp by means of hair density, hair widths.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria

• written informed consent

• clinically healthy skin and hair appearance

• being free of any dermatological condition

• acceptance to abstain from sunbathing

• acceptance to abstain from solarium

• agreement to use the same skin cleaning and caring procedures during the study

Exclusion Criteria:

• regular smoking

• regular alcohol intake

• any dermatological condition or skin affection which may interfere with the study assessments (psoriasis, atopic dermatitis or other lesions at the investigational sites)

• clinically significant, possibly unstable medical conditions due to gravidity such as gestosis, eclampsia or thrombosis.

• Criteria related to treatments and products such as current topical or systemic treatment possibly affecting the skin, (diuretics, cholesterol-lowering drugs, hormones) during past four weeks

• therapeutic ultraviolet radiation within six weeks before inclusion

• increased ultraviolet-exposure within six weeks before inclusion

Related Conditions & MeSH terms

• Skin Microbiome

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (23)

Boyer G, Lachmann N, Bellemere G, De Belilovsky C, Baudouin C. Effects of pregnancy on skin properties: A biomechanical approach. Skin Res Technol. 2018 Nov;24(4):551-556. doi: 10.1111/srt.12465. Epub 2018 Feb 26. — View Citation

Capone KA, Dowd SE, Stamatas GN, Nikolovski J. Diversity of the human skin microbiome early in life. J Invest Dermatol. 2011 Oct;131(10):2026-32. doi: 10.1038/jid.2011.168. Epub 2011 Jun 23. — View Citation

Ciechanowicz P, Sikora M, Taradaj K, Ruta A, Rakowska A, Kociszewska-Najman B, Wielgos M, Rudnicka L. Skin changes during pregnancy. Is that an important issue for pregnant women? Ginekol Pol. 2018;89(8):449-52. doi: 10.5603/GP.a2018.0077. — View Citation

Costello EK, Carlisle EM, Bik EM, Morowitz MJ, Relman DA. Microbiome assembly across multiple body sites in low-birthweight infants. mBio. 2013 Oct 29;4(6):e00782-13. doi: 10.1128/mBio.00782-13. — View Citation

Dominguez-Bello MG, Costello EK, Contreras M, Magris M, Hidalgo G, Fierer N, Knight R. Delivery mode shapes the acquisition and structure of the initial microbiota across multiple body habitats in newborns. Proc Natl Acad Sci U S A. 2010 Jun 29;107(26):11971-5. doi: 10.1073/pnas.1002601107. Epub 2010 Jun 21. — View Citation

Findley K, Grice EA. The skin microbiome: a focus on pathogens and their association with skin disease. PLoS Pathog. 2014 Nov 13;10(10):e1004436. doi: 10.1371/journal.ppat.1004436. eCollection 2014 Oct. No abstract available. — View Citation

Fluhr JW, Darlenski R. Skin Surface pH in Newborns: Origin and Consequences. Curr Probl Dermatol. 2018;54:26-32. doi: 10.1159/000489515. Epub 2018 Aug 21. — View Citation

Hughes-Formella B, Wunderlich O, Williams R, Fernandez J, Kim YZ, Wigger-Alberti W, Pecquet S, Moodycliffe A. Comparison of Skin Structural and Functional Parameters in Well-Nourished and Moderately Undernourished Infants. Skin Pharmacol Physiol. 2019;32(4):212-223. doi: 10.1159/000499434. Epub 2019 Jun 5. — View Citation

Lehtimaki J, Karkman A, Laatikainen T, Paalanen L, von Hertzen L, Haahtela T, Hanski I, Ruokolainen L. Patterns in the skin microbiota differ in children and teenagers between rural and urban environments. Sci Rep. 2017 Mar 31;7:45651. doi: 10.1038/srep45651. — View Citation

Ludriksone L, Garcia Bartels N, Kanti V, Blume-Peytavi U, Kottner J. Skin barrier function in infancy: a systematic review. Arch Dermatol Res. 2014 Sep;306(7):591-9. doi: 10.1007/s00403-014-1458-6. Epub 2014 Mar 5. — View Citation

Manus MB, Kuthyar S, Perroni-Maranon AG, Nunez-de la Mora A, Amato KR. Infant Skin Bacterial Communities Vary by Skin Site and Infant Age across Populations in Mexico and the United States. mSystems. 2020 Nov 3;5(6):e00834-20. doi: 10.1128/mSystems.00834-20. — View Citation

Martins-Costa GM, Bakos R. Total Body Photography and Sequential Digital Dermoscopy in Pregnant Women. Dermatol Pract Concept. 2019 Apr 30;9(2):126-131. doi: 10.5826/dpc.0902a08. eCollection 2019 Apr. — View Citation

Muallem MM, Rubeiz NG. Physiological and biological skin changes in pregnancy. Clin Dermatol. 2006 Mar-Apr;24(2):80-3. doi: 10.1016/j.clindermatol.2005.10.002. — View Citation

Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Invest Dermatol. 2008 Jul;128(7):1728-36. doi: 10.1038/sj.jid.5701239. Epub 2008 Jan 17. — View Citation

Oranges T, Dini V, Romanelli M. Skin Physiology of the Neonate and Infant: Clinical Implications. Adv Wound Care (New Rochelle). 2015 Oct 1;4(10):587-595. doi: 10.1089/wound.2015.0642. — View Citation

Panicker VV, Riyaz N, Balachandran PK. A clinical study of cutaneous changes in pregnancy. J Epidemiol Glob Health. 2017 Mar;7(1):63-70. doi: 10.1016/j.jegh.2016.10.002. Epub 2016 Nov 19. — View Citation

Pierard-Franchimont C, Pierard GE. Alterations in hair follicle dynamics in women. Biomed Res Int. 2013;2013:957432. doi: 10.1155/2013/957432. Epub 2013 Dec 24. — View Citation

Surber C, Dragicevic N, Kottner J. Skin Care Products for Healthy and Diseased Skin. Curr Probl Dermatol. 2018;54:183-200. doi: 10.1159/000489532. Epub 2018 Aug 21. — View Citation

Thom E. Pregnancy and the hair growth cycle: anagen induction against hair growth disruption using Nourkrin(R) with Marilex(R) , a proteoglycan replacement therapy. J Cosmet Dermatol. 2017 Sep;16(3):421-427. doi: 10.1111/jocd.12286. Epub 2016 Sep 23. — View Citation

Visscher MO, Adam R, Brink S, Odio M. Newborn infant skin: physiology, development, and care. Clin Dermatol. 2015 May-Jun;33(3):271-80. doi: 10.1016/j.clindermatol.2014.12.003. Epub 2014 Dec 8. — View Citation

Vora RV, Gupta R, Mehta MJ, Chaudhari AH, Pilani AP, Patel N. Pregnancy and skin. J Family Med Prim Care. 2014 Oct-Dec;3(4):318-24. doi: 10.4103/2249-4863.148099. — View Citation

Younge NE, Araujo-Perez F, Brandon D, Seed PC. Early-life skin microbiota in hospitalized preterm and full-term infants. Microbiome. 2018 May 31;6(1):98. doi: 10.1186/s40168-018-0486-4. — View Citation

Zhu T, Liu X, Kong FQ, Duan YY, Yee AL, Kim M, Galzote C, Gilbert JA, Quan ZX. Age and Mothers: Potent Influences of Children's Skin Microbiota. J Invest Dermatol. 2019 Dec;139(12):2497-2505.e6. doi: 10.1016/j.jid.2019.05.018. Epub 2019 Aug 13. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline stratum corneum hydratation (SCH) at 4 weeks and 6 months after delivery	measurement of skin hydration: arbitrary units 0-120 , whereas higher readings indicate higher stratum corneum hydration	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Primary	Change from baseline Skin surface pH at 4 weeks and 6 months after delivery	Skin pH-meter measurement (range from 4 to 7,5)	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Primary	Change from baseline Transepidermal water loss (TEWL ) at 4 weeks and 6 months after delivery	Transepidermal waterloss through the stratum corneum in g per hour per m2 (range: 0,0-60,0 g/m2/h)	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Primary	Change from baseline Skin stiffness and elasticity at 4 weeks and 6 months after delivery	total extensibility (Uf, mm), Structural elasticity Uf) of the skin (0,00-0,50 Uf in mm/degree)	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Primary	Change from baseline Epidermal thickness at 4 weeks and 6 months after delivery	Standardized images via Optical coherence tomography (OCT) measured in mm	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Primary	Change from baseline Skin surface topography at 4 weeks and 6 months after delivery	Standardized images via Visioscan; RA (arithmetic mean roughness) in µm; RZ (arithmetic mean roughness from five sampling length) in µm	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Primary	Change from baseline Skin microbiome at 4 weeks and 6 months after delivery	Bacterial diversity Relative abundance of phylotypes (operational taxonomic units, (OTUs)	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Primary	Change from baseline Hair growth at 4 weeks and 6 months after delivery	Measurement of Hair thickness	baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery