Metabolomic Profile in Breastfed Late Preterm Infants

NCT06052592 | Completed

• 1 other identifier: 1680/CE Lazio 1
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

Exclusive breast milk is recommended from birth to 6 months of life to promote the development of a balanced intestinal microbiota. Human milk provides several bioactive components, from natural probiotics such as Bifidobacterium spp. and Lactobacillus spp., to their metabolites which colonize the intestine of the newborn. However, if breast milk is not available or insufficient, it is used formula milk as a substitute. Infant formula can be supplemented with postbiotics to promote maturation of immune, metabolic and microbial components, similar to breast milk. Postbiotics are preparations composed of both microbial constituents and their metabolites, produced during fermentation.

Conditions

Formula Milk; Breast Milk Collection; Postbiotic Supplemented Formula Milk

Keywords

newborn; human milk; formula milk; postbiotic

Outcome Measures

Primary Outcomes (3)

• Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants

  To detect the differences in the metabolome of the newborns

  5 days after delivery

• Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants

  To detect the differences in the metabolome of the newborns

  1 month after delivery

• Evaluation of metabolomic profile by liquid chromatography mass spectrometry in breastfed late preterm infants

  To detect the differences in the metabolome of the newborns

  3 months after delivery

Study Arms (3)

Group A

Newborns fed with formula milk supplemented with 20 mg/day of fermented FOS from Lactobacillus paracasei strain CNCM I-5220 and Vitamin D (0.5 ml of SMART D3 MATRIX)

Other: Milk

Group B

Newborns fed with formula milk

Other: Milk

Group C

Newborns fed with exclusive breast milk

Other: Milk

Interventions

Milk OTHER

Newborns will be fed with breast milk, formula milk or postbiotic formula milk

Group A; Group B; Group C

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants born at Ospedale Buon Consiglio Fatebenefratelli, Naples

You may qualify if:

• Weight appropriate to gestational age (percentiles \>10th and \<90th)
• Written informed consent

You may not qualify if:

• Cardiological diseases
• Liver disease
• Gastrointestinal diseases with malabsorption
• Endocrinological diseases
• Perinatal infections
• Metabolic and genetic diseases
• Born to mothers with endocrinological and metabolic diseases
• Withdrawal of informed consent

Sponsors & Collaborators

• Ospedale Buon Consiglio Fatebenefratelli: lead
• University of Salerno: collaborator

Study Sites (2)

Department of Pharmacy, University of Salerno

Salerno, Naples, 84084, Italy

Location

Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital

Napoli, Napoli, 80123, Italy

Location

MeSH Terms

Conditions

Breast Milk Expression

Interventions

Milk

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Giuseppe De Bernardo, MD

  Ospedale Buon Consiglio Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Woman and Child

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: September 25, 2023
• Study Start: March 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)