deltatrials
Completed OBSERVATIONAL NCT03912038

Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.

Sponsor: Hospital General de México Dr. Eduardo Liceaga

Interventions No intervention.
Updated 10 times since 2019 Last updated: Sep 20, 2023 Started: Jan 26, 2018 Primary completion: Dec 31, 2022 Completion: Dec 31, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03912038, this observational or N/A phase trial focuses on Microbial Colonization and remains completed. Sponsored by Hospital General de México Dr. Eduardo Liceaga, it has been updated 10 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

The consumption of non-caloric sweeteners (ENC) is increasingly common in our country due to its wide use in all types of food and beverages, even those not labeled as "diet". Despite its widespread use and being an alternative to the consumption of sugars, several studies have shown that frequent ENC users are also at risk of excessive weight gain, type II diabetes, and cardiovascular diseases. In addition to this, the consumption of ENC in the early stages of life may predispose to the development of metabolic disorders later in life.The ENC have been shown to have effects on the health of those who consume them, causing metabolic disorders, weight gain and changes in the microbiota. The newborns, in whom gut microbiota is in the process of being established, influenced by the vaginal and intestinal microbiota of the mother, as well as by the mother's milk, are a vulnerable population in whom the effect of ENC consumption has not been investigated. This makes it relevant to study the prevalence of ENC in breast milk and umbilical cord blood of their newborns and to evaluate the composition of the intestinal and milk microbiota in order to identify changes attributable to the consumption...

The consumption of non-caloric sweeteners (ENC) is increasingly common in our country due to its wide use in all types of food and beverages, even those not labeled as "diet". Despite its widespread use and being an alternative to the consumption of sugars, several studies have shown that frequent ENC users are also at risk of excessive weight gain, type II diabetes, and cardiovascular diseases. In addition to this, the consumption of ENC in the early stages of life may predispose to the development of metabolic disorders later in life.The ENC have been shown to have effects on the health of those who consume them, causing metabolic disorders, weight gain and changes in the microbiota. The newborns, in whom gut microbiota is in the process of being established, influenced by the vaginal and intestinal microbiota of the mother, as well as by the mother's milk, are a vulnerable population in whom the effect of ENC consumption has not been investigated. This makes it relevant to study the prevalence of ENC in breast milk and umbilical cord blood of their newborns and to evaluate the composition of the intestinal and milk microbiota in order to identify changes attributable to the consumption of ENC.

Status Flow

~May 2019 – ~Nov 2020 · 18 months · monthly snapshotRecruiting~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotRecruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotRecruiting~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshotActive Not Recruiting~Dec 2021 – ~Sep 2023 · 21 months · monthly snapshotActive Not Recruiting~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshotUnknown Status~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Oct 2023 — Jul 2024 [monthly]

    Completed

    Status: Unknown StatusCompleted

  5. Sep 2023 — Oct 2023 [monthly]

    Unknown Status

    Status: Active Not RecruitingUnknown Status

Show 5 earlier versions
  1. Dec 2021 — Sep 2023 [monthly]

    Active Not Recruiting

  2. Sep 2021 — Dec 2021 [monthly]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting

  3. Jan 2021 — Sep 2021 [monthly]

    Recruiting

  4. Nov 2020 — Jan 2021 [monthly]

    Recruiting

  5. May 2019 — Nov 2020 [monthly]

    Recruiting

    First recorded

Jan 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hospital General de México Dr. Eduardo Liceaga
Data source: Hospital General de México Dr. Eduardo Liceaga

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations