Shaping Microbiome in the First 1,000 Days of Life

NCT04122612 | Completed

• 1 other identifier: 20191004
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Events occurring in the early stages of life play an important role in the development of chronic diseases; diet and lifestyle during pregnancy are recognized to be crucial determinants in modulating offspring microbiota, throughout a vertical transfer of dysbiotic maternal ambient. Moreover, the intestinal colonization is maximized in the first two years of life through newborn's type and time of feeding. This study will provide the starting point for a future prospective observational study to assessing the association between maternal lifestyle with infant microbiota and their influence future health.

Conditions

Microbial Colonization

Keywords

microbiota; 1000 days; maternal lifestyle; diet; pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in intestinal microbiota composition from 0 to 12 months of life

  Investigate the intestinal microbiota development of infants at 0, 1, 6, 12 months after birth by: i) Identifying the relative abundance of the dominant organism genera; ii) Assessing the microbial diversity (α-diversity); iii) Assessing inter-individual variation (β-diversity).

  0 months (2-3 days after birth); 1 months after birth; 6 months after birth; 12 months after birth.

Secondary Outcomes (1)

• examine the association of maternal and infants factor and the intestinal microbiota development of infants.

  0 months (2-3 days after birth); 1 months after birth; 6 months after birth; 12 months after birth.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 dyads (mother/new-born) attending the Neonatal Unit, Fondazione IRCCS Policlinico San Matteo, Pavia (Italy)

You may qualify if:

• Infants of both sexes born to natural or caesarean delivery;
• Gestational age between 35 and 42 completed weeks;
• Italian-speaking parents;
• Ability of the parent/guardian to give informed consent;
• Ability of the mother to respond to the structured interview/questionnaires;

You may not qualify if:

• Children or mothers with genetic/congenital diseases;
• Children hospitalized immediately after birth;
• Children selected for other clinical studies;
• Presence of gestational diabetes;
• Presence of hyperthyroidism during pregnancy;
• Parents refusing to sign the informed consent.

Sponsors & Collaborators

• University of Pavia: lead
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Istituti Clinici Scientifici Maugeri SpA: collaborator
• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: collaborator

Study Sites (1)

IRCCSSMP

Pavia, 27100, Italy

Location

Related Publications (2)

• Vacca M, Raspini B, Calabrese FM, Porri D, De Giuseppe R, Chieppa M, Liso M, Cerbo RM, Civardi E, Garofoli F, Cena H, De Angelis M. The establishment of the gut microbiota in 1-year-aged infants: from birth to family food. Eur J Nutr. 2022 Aug;61(5):2517-2530. doi: 10.1007/s00394-022-02822-1. Epub 2022 Feb 25.

  PMID: 35211851 DERIVED

• Raspini B, Porri D, De Giuseppe R, Chieppa M, Liso M, Cerbo RM, Civardi E, Garofoli F, Monti MC, Vacca M, De Angelis M, Cena H. Prenatal and postnatal determinants in shaping offspring's microbiome in the first 1000 days: study protocol and preliminary results at one month of life. Ital J Pediatr. 2020 Apr 15;46(1):45. doi: 10.1186/s13052-020-0794-8.

  PMID: 32293504 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

fecal and urine sample

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hellas Cena

  Università di Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: September 23, 2018
• Primary Completion: October 7, 2019
• Study Completion: October 7, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

IT (1)