NCT03912038

Brief Summary

This study evaluates the presence and quantity of non-caloric sweeteners in newborns umbilical cord blood, and in their mother's breast milk at delivery, at 2 months, 4 months and 6 months of age. Microbiota composition will be evaluated in milk and in feces of both mother and child.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

4.9 years

First QC Date

April 8, 2019

Last Update Submit

September 20, 2023

Conditions

Microbial Colonization

Keywords

Non-caloric sweetenersmicrobiotabreast milkumbilical cord

Outcome Measures

Primary Outcomes (11)

  • Microbiota composition in feces

    Composition of feces microbiota in mother and newborn

    2 months

  • Microbiota composition in feces

    Composition of feces microbiota in mother and newborn

    4 months

  • Microbiota composition in feces

    Composition of feces microbiota in mother and newborn

    6 months

  • Microbiota composition in breast milk

    Composition of breast milk microbiota

    0 months

  • Microbiota composition in breast milk

    Composition of breast milk microbiota

    2 months

  • Microbiota composition in breast milk

    Composition of breast milk microbiota

    4 months

  • Microbiota composition in breast milk

    Composition of breast milk microbiota

    6 months

  • Non-caloric sweeteners levels at birth

    Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL

    at birth

  • Non-caloric sweeteners levels 2 months follow-up

    Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up

    2 months after birth

  • Non-caloric sweeteners levels 4 months follow-up

    Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up

    4 months after birth

  • Non-caloric sweeteners levels 6 months follow-up

    Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up

    6 months after birth

Study Arms (3)

Null or low consumption

No-intervention. The group consists of women who have reported a null or low consumption of non-caloric sweeteners during late pregnancy.

Other: No intervention.

Moderate consumption

No-intervention. The group consists of women who have reported a moderate consumption of non-caloric sweeteners during late pregnancy.

Other: No intervention.

High consumption

No-intervention. The group consists of women who have reported a high consumption of non-caloric sweeteners during late pregnancy.

Other: No intervention.

Interventions

No intervention.OTHER

No intervention

High consumptionModerate consumptionNull or low consumption

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women in labor who come to the service of gynecology and obstetrics General Hospital Mexico. Usually, they are residents from Mexico City and metropolitan area (Mexico State).

You may qualify if:

  • Age 18-40 years old
  • Women in labor
  • Consent to participate in the study

You may not qualify if:

  • Pre-term delivery (\<30 weeks)
  • Metabolic diseases (insulin resistance, diabetes, gestational diabetes)
  • Hypertension
  • Thyroid disease
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Mexico Dr. Eduardo Liceaga

Mexico City, 06726, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Feces Breast milk Urine

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marcela Esquivel, PhD

    Hospital General de México Dr. Eduardo Liceaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Sciences Researcher

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 11, 2019

Study Start

January 26, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

ME(1)