Vaginal InfectionNCT05005286
Evaluation of Breastmilk Microbiota as a Function for Immunity
An observational study of Vaginal Infection and Breastmilk Collection, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The aim of this study is to evaluate the difference of breast milk microbiota between mothers with and without vaginal infections during pregnancy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection, Breastmilk Collection
- What is being tested?
- Past history of vaginal Infections
- How many people
- 85 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2020to 30 Nov 2021
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects will be recruited from HUSM Kubang Kerian, USM Main Campus Penang, USM Kelantan and Institut Perubatan \& Pergigian Termaju USM.
Who may be able to join
- Lactating women
- Willing to commit throughout the experiment
Who cannot join
- Long term medication due to certain illnesses for over 3 months during pregnancy
- Gestational diabetes during pregnancy
- History of diabetes, coronary heart disease, and hypertension in life
- BMI before pregnancy above 24.9
- Consuming probiotic product during pregnancy
- Consuming probiotic product during lactation period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Microbiota Composition and Antimicrobial Property From Breastmilk of Mothers With and Without Pregnancy Vaginal Infections
The aim of this study is to evaluate the difference of breast milk microbiota between mothers with and without vaginal infections during pregnancy.
Read the detailed description
The maternal microbiota is one of the relevant factors in the development of the infant's immune system, whereby the colonization of microbes in human begins at birth, when the newborn baby is exposed to maternal vaginal, gastrointestinal microbiota and as well as the microbes from the external environment. The neonatal intestine is colonized by symbiotic bacteria can be divided into four main steps; (i) acquisition of maternal vaginal, colonic, and skin flora at birth; (ii) introduction of oral feedings (breastfeeding or formula feeding); (iii) weaning; and (iv) acquisition of complete adult colonization.
Breastfeeding is associated with the protection of the infants from either infections or infection-related conditions, such as gastroenteritis, upper and lower respiratory tract infection, acute otitis media, urinary tract infection, neonatal septicaemia and necrotizing enterocoltis. The protection is through the combination of action of the breast milk components, such as maternal immunoglobulins, immunocompetent cells, or variety of anti-microbial compounds. Besides that, breast milk also contains prebiotic substances which may selectively stimulate the growth of limited number of beneficial bacteria in the gut.
A total number of 100 lactating mothers are needed for this study. Subjects will be recruited from HUSM Kubang Kerian, USM Main Campus Penang, and Institut Perubatan \& Pergigian Termaju USM Penang. The subjects will be explained on all related information in the consent form prior to signing. The procedure of collecting sample is hands must be washed before milk expression, and nipples are cleaned with sterile water and alcohol swab. 15mL of fresh breast milk will be collected into a tube and stored at -20℃ until further analyses.
- Conditions
- Vaginal Infection, Breastmilk Collection
- Being tested
- Past history of vaginal Infections
- Keywords
- Breastmilk, Vaginal Infection, Immunity properties
- Medical subject headings
- Vaginitis, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Past history of vaginal InfectionsOther
With or without vaginal infection during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Group A | Lactating women with vaginal infection during pregnancy as confirmed by past medical records Receives: Other: Past history of vaginal Infections | |
| Group B | Lactating women without any vaginal infection during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk microbiota profiles
Differences in breastmilk microbiota profiles via pyrosequencing from breastmilk of women with or without history of vaginal infection during pregnancy
Measured: 6 months
Secondary outcomes (2)
Immuno-modulatory properties of breastmilk
Differences in breastmilk concentrations of immunity parameters such as immunoglobulins and cytokines from breastmilk of women with or without history of vaginal infection during pregnancy
Measured: 6 months
Antimicrobial properties of breastmilk microbiota
Differences in antimicrobial properties against vaginal pathogens using breastmilk of women with or without history of vaginal infection during pregnancy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Dec 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Min T Liong, PhD, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005286
- Sponsor's protocol ID
- USM/JEPeM/20090500
- Status last verified
- Mar 2022
- First submitted
- 8 Aug 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microbiota Composition and Antimicrobial Property From Breastmilk of Mothers With and Without Pregnancy Vaginal Infections
- ClinicalTrials.gov ID
- NCT05005286
- Acronym / sponsor ID
- USM/JEPeM/20090500
- Conditions
- Vaginal Infection, Breastmilk Collection
- Keywords
- Breastmilk, Vaginal Infection, Immunity properties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 13 Aug 2021 (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.
The aim of this study is to evaluate the difference of breast milk microbiota between mothers with and without vaginal infections during pregnancy.
Detailed description
The maternal microbiota is one of the relevant factors in the development of the infant's immune system, whereby the colonization of microbes in human begins at birth, when the newborn baby is exposed to maternal vaginal, gastrointestinal microbiota and as well as the microbes from the external environment. The neonatal intestine is colonized by symbiotic bacteria can be divided into four main steps; (i) acquisition of maternal vaginal, colonic, and skin flora at birth; (ii) introduction of oral feedings (breastfeeding or formula feeding); (iii) weaning; and (iv) acquisition of complete adult colonization.
Breastfeeding is associated with the protection of the infants from either infections or infection-related conditions, such as gastroenteritis, upper and lower respiratory tract infection, acute otitis media, urinary tract infection, neonatal septicaemia and necrotizing enterocoltis. The protection is through the combination of action of the breast milk components, such as maternal immunoglobulins, immunocompetent cells, or variety of anti-microbial compounds. Besides that, breast milk also contains prebiotic substances which may selectively stimulate the growth of limited number of beneficial bacteria in the gut.
A total number of 100 lactating mothers are needed for this study. Subjects will be recruited from HUSM Kubang Kerian, USM Main Campus Penang, and Institut Perubatan \& Pergigian Termaju USM Penang. The subjects will be explained on all related information in the consent form prior to signing. The procedure of collecting sample is hands must be washed before milk expression, and nipples are cleaned with sterile water and alcohol swab. 15mL of fresh breast milk will be collected into a tube and stored at -20℃ until further analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Past history of vaginal InfectionsLactating women with vaginal infection during pregnancy as confirmed by past medical records |
| Group B | – | –Lactating women without any vaginal infection during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from HUSM Kubang Kerian, USM Main Campus Penang, USM Kelantan and Institut Perubatan \& Pergigian Termaju USM.
Key inclusion criteria (2 listed)
- Lactating women
- Willing to commit throughout the experiment
Key exclusion criteria (6 listed)
- Long term medication due to certain illnesses for over 3 months during pregnancy
- Gestational diabetes during pregnancy
- History of diabetes, coronary heart disease, and hypertension in life
- BMI before pregnancy above 24.9
- Consuming probiotic product during pregnancy
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 |
|---|---|---|
| Past history of vaginal InfectionsWith or without vaginal infection during pregnancy | Other | Group A |
Primary outcome
Breastmilk microbiota profiles
Time frame: 6 months
Differences in breastmilk microbiota profiles via pyrosequencing from breastmilk of women with or without history of vaginal infection during pregnancy
2 secondary outcomes
Immuno-modulatory properties of breastmilk
Time frame: 6 months
Antimicrobial properties of breastmilk microbiota
Time frame: 6 months
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 18 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Vaginal Infection
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Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
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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.
Min T Liong, PhD principal investigator
Universiti Sains Malaysia
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 Vaginal Infection and Breastmilk Collection, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 2 inclusion and 6 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 18 Mar 2022. 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 Malaysia. 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?
Breastmilk microbiota profiles (time frame: 6 months). 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 18 Mar 2022.