Human Milk and Infant Intestinal Microbiome Study

Breast Feeding Clinical Trial

Official title:

Human Milk and Infant Intestinal Microbiome Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181269
• Other study ID #: IRB# 19913
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: December 2018
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women scheduled to deliver at the University of Virginia Health System

• Women 18 years or older and their newborn infant

• Stated intent to exclusively breastfeed for the duration of post-partum hospital admission

• To have physical custody of their child when they are discharged from the hospital

Exclusion Criteria:

• Maternal antibiotic use in the 3 months prior to delivery

• Consumption of alcohol in the 3 months prior to delivery

• Recreational drug use in the 3 months prior to delivery

• Serious gastrointestinal conditions requiring medical intervention or medication during pregnancy (e.g. Crohn's disease, ulcerative colitis, celiac disease, gastrointestinal infections)

• Serious health conditions that require medication during pregnancy

Related Conditions & MeSH terms

• Breast Feeding
• Human Microbiome

Intervention

Other:
• Intervention education
An education package that includes an enhanced emphasis on maternal-infant skin-to-skin contact and a detailed activity log for recording early post-partum care practices that includes specific skin-to-skin contact time and frequency goals.
• Placebo Education
An education package that includes a basic emphasis on maternal-infant skin-to-skin contact, as well as other general post-partum care practices and a general early post-partum care practices log without specific skin-to-skin contact goals.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (11)

Jost T, Lacroix C, Braegger CP, Rochat F, Chassard C. Vertical mother-neonate transfer of maternal gut bacteria via breastfeeding. Environ Microbiol. 2014 Sep;16(9):2891-904. doi: 10.1111/1462-2920.12238. Epub 2013 Sep 3. — View Citation

Lindberg E, Adlerberth I, Hesselmar B, Saalman R, Strannegård IL, Aberg N, Wold AE. High rate of transfer of Staphylococcus aureus from parental skin to infant gut flora. J Clin Microbiol. 2004 Feb;42(2):530-4. — View Citation

Marín Gabriel MA, Llana Martín I, López Escobar A, Fernández Villalba E, Romero Blanco I, Touza Pol P. Randomized controlled trial of early skin-to-skin contact: effects on the mother and the newborn. Acta Paediatr. 2010 Nov;99(11):1630-4. doi: 10.1111/j.1651-2227.2009.01597.x. — View Citation

Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11:CD003519. Review. — View Citation

Murphy K, Curley D, O'Callaghan TF, O'Shea CA, Dempsey EM, O'Toole PW, Ross RP, Ryan CA, Stanton C. The Composition of Human Milk and Infant Faecal Microbiota Over the First Three Months of Life: A Pilot Study. Sci Rep. 2017 Jan 17;7:40597. doi: 10.1038/srep40597. — View Citation

Neu J, Rushing J. Cesarean versus vaginal delivery: long-term infant outcomes and the hygiene hypothesis. Clin Perinatol. 2011 Jun;38(2):321-31. doi: 10.1016/j.clp.2011.03.008. Review. — View Citation

Palmer C, Bik EM, DiGiulio DB, Relman DA, Brown PO. Development of the human infant intestinal microbiota. PLoS Biol. 2007 Jul;5(7):e177. Epub 2007 Jun 26. — View Citation

Pannaraj PS, Li F, Cerini C, Bender JM, Yang S, Rollie A, Adisetiyo H, Zabih S, Lincez PJ, Bittinger K, Bailey A, Bushman FD, Sleasman JW, Aldrovandi GM. Association Between Breast Milk Bacterial Communities and Establishment and Development of the Infant Gut Microbiome. JAMA Pediatr. 2017 Jul 1;171(7):647-654. doi: 10.1001/jamapediatrics.2017.0378. — View Citation

Posthuma S, Korteweg FJ, van der Ploeg JM, de Boer HD, Buiter HD, van der Ham DP. Risks and benefits of the skin-to-skin cesarean section - a retrospective cohort study. J Matern Fetal Neonatal Med. 2017 Jan;30(2):159-163. Epub 2016 Mar 29. — View Citation

Rutten N, Van der Gugten A, Uiterwaal C, Vlieger A, Rijkers G, Van der Ent K. Maternal use of probiotics during pregnancy and effects on their offspring's health in an unselected population. Eur J Pediatr. 2016 Feb;175(2):229-35. doi: 10.1007/s00431-015-2618-1. Epub 2015 Aug 30. — View Citation

Schloss PD, Iverson KD, Petrosino JF, Schloss SJ. The dynamics of a family's gut microbiota reveal variations on a theme. Microbiome. 2014 Jul 21;2:25. doi: 10.1186/2049-2618-2-25. eCollection 2014. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin-to-skin contact	Self-reported magnitude of maternal-infant skin-to-skin contact	Duration of hospital admission after delivery (2-3 days)
Secondary	Maternal skin microbiome	Maternal breast area skin microbiome	Duration of hospital admission after delivery (2-3 days)
Secondary	Maternal breast milk microbiome	Maternal first and early milk microbiome	Duration of hospital admission after delivery (2-3 days)
Secondary	Infant intestinal microbiome	Infant fecal microbiome	Duration of hospital admission after delivery (2-3 days)
Secondary	Maternal dietary intake	Maternal dietary intake of probiotic or culture-enhanced foods	During pregnancy