Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life

Infant Development Clinical Trial

Official title:

Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236194
• Other study ID #: PRAMS034493EP
• Status: Completed
• Start date: July 17, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: February 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.

Description:

Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity.

This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2019
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. full-term infant (> 36 0/7 weeks gestational age) without significant morbidity

2. nursery/NICU/maternity stay of 7 days or less

3. participant children can be (but do not have to be) twins

4. English speaking mother

5. care provided at an HMC affiliated clinic

6. a working telephone number

Exclusion Criteria:

1. prenatal ultrasound presence of intrauterine growth retardation (IUGR)

2. infant birth weight <2250 grams

3. presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)

4. any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc.

5. plan for newborn to be adopted

6. plan to move from Central Pennsylvania within 1 year

7. have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)

Related Conditions & MeSH terms

• Infant Development

Locations

Country	Name	City	State
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Penn State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bäckhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Datchary P, Li Y, Xia Y, Xie H, Zhong H, Khan MT, Zhang J, Li J, Xiao L, Al-Aama J, Zhang D, Lee YS, Kotowska D, Colding C, Tremaroli V, Yin Y, Bergman S, Xu X, Madsen L, Kristiansen K, Dahlgren J, Wang J. Dynamics and Stabilization of the Human Gut Microbiome during the First Year of Life. Cell Host Microbe. 2015 Jun 10;17(6):852. doi: 10.1016/j.chom.2015.05.012. Epub 2015 Jun 10. — View Citation

Chu DM, Ma J, Prince AL, Antony KM, Seferovic MD, Aagaard KM. Maturation of the infant microbiome community structure and function across multiple body sites and in relation to mode of delivery. Nat Med. 2017 Mar;23(3):314-326. doi: 10.1038/nm.4272. Epub 2017 Jan 23. — View Citation

Gomez A, Nelson KE. The Oral Microbiome of Children: Development, Disease, and Implications Beyond Oral Health. Microb Ecol. 2017 Feb;73(2):492-503. doi: 10.1007/s00248-016-0854-1. Epub 2016 Sep 14. Review. — View Citation

Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015. Review. Erratum in: Front Pediatr. 2015;3:60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome outcome	Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals	birth to 1 year
Secondary	Genetic variation	Associations between genetic variation and microbiome diversity	birth to 1 year
Secondary	Genetic variation	Genetic variation as it relates to growth outcomes	birth to 1 year