Microbial ColonizationNCT03912038
Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.
An observational study of Microbial Colonization, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- How many people
- 178 participants
- Where
- 1 siteMexico
- Study dates
- 26 Jan 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- Age 18-40 years old
- Women in labor
- Consent to participate in the study
Who cannot join
- Pre-term delivery (<30 weeks)
- Metabolic diseases (insulin resistance, diabetes, gestational diabetes)
- Hypertension
- Thyroid disease
- Cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Microbial Colonization
- Being tested
- No intervention.
- Keywords
- Non-caloric sweeteners, microbiota, breast milk, umbilical cord
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention.Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition in feces
Composition of feces microbiota in mother and newborn
Measured: 2 months
Microbiota composition in feces
Composition of feces microbiota in mother and newborn
Measured: 4 months
Microbiota composition in feces
Composition of feces microbiota in mother and newborn
Measured: 6 months
Microbiota composition in breast milk
Composition of breast milk microbiota
Measured: 0 months
Microbiota composition in breast milk
Composition of breast milk microbiota
Measured: 2 months
Microbiota composition in breast milk
Composition of breast milk microbiota
Measured: 4 months
Microbiota composition in breast milk
Composition of breast milk microbiota
Measured: 6 months
Non-caloric sweeteners levels at birth
Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start26 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marcela Esquivel V, Hospital General de México Dr. Eduardo Liceaga
- Investigators
- Marcela Esquivel, PhD, Principal investigator, Hospital General de México Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912038
- Sponsor's protocol ID
- DI/17/301/05/075
- Status last verified
- Sep 2023
- First submitted
- 8 Apr 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-caloric Sweeteners Levels in Breast Milk and Newborn's Blood and Effect on Microbiota's Composition.
- ClinicalTrials.gov ID
- NCT03912038
- Acronym / sponsor ID
- DI/17/301/05/075
- Conditions
- Microbial Colonization
- Keywords
- Non-caloric sweeteners, microbiota, breast milk, umbilical cord
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Null or low consumption | – | Other: No intervention.No-intervention. The group consists of women who have reported a null or low consumption of non-caloric sweeteners during late pregnancy. |
| Moderate consumption | – | Other: No intervention.No-intervention. The group consists of women who have reported a moderate consumption of non-caloric sweeteners during late pregnancy. |
| High consumption | – | Other: No intervention.No-intervention. The group consists of women who have reported a high consumption of non-caloric sweeteners during late pregnancy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (3 listed)
- Age 18-40 years old
- Women in labor
- Consent to participate in the study
Key exclusion criteria (5 listed)
- Pre-term delivery (<30 weeks)
- Metabolic diseases (insulin resistance, diabetes, gestational diabetes)
- Hypertension
- Thyroid disease
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention.No intervention | Other | High consumption, Moderate consumption, Null or low consumption |
Primary outcome
Microbiota composition in feces
Time frame: 2 months
Composition of feces microbiota in mother and newborn
Microbiota composition in feces
Time frame: 4 months
Composition of feces microbiota in mother and newborn
Microbiota composition in feces
Time frame: 6 months
Composition of feces microbiota in mother and newborn
Microbiota composition in breast milk
Time frame: 0 months
Composition of breast milk microbiota
Microbiota composition in breast milk
Time frame: 2 months
Composition of breast milk microbiota
Microbiota composition in breast milk
Time frame: 4 months
Composition of breast milk microbiota
Microbiota composition in breast milk
Time frame: 6 months
Composition of breast milk microbiota
Non-caloric sweeteners levels at birth
Time frame: at birth
Non-caloric sweeteners levels in milk, plasma, umbilical cord plasma, urine in mg/mL
Non-caloric sweeteners levels 2 months follow-up
Time frame: 2 months after birth
Non-caloric sweeteners levels in breast milk and urine in the 2 months follow-up
Non-caloric sweeteners levels 4 months follow-up
Time frame: 4 months after birth
Non-caloric sweeteners levels in breast milk and urine in the 4 months follow-up
Non-caloric sweeteners levels 6 months follow-up
Time frame: 6 months after birth
Non-caloric sweeteners levels in breast milk and urine in the 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela Esquivel, PhD principal investigator
Hospital General de México Dr. Eduardo Liceaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota composition in feces (time frame: 2 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.