HealthyNCT06412042
Probiotic in Infant Growth, Allergy and Immunity Study
A study testing Probiotic BLa80 in people with Healthy and Infant ALL, run by Wecare Probiotics Co., Ltd. at 1 site in Indonesia.
Trial summary
To evaluate the intervention effects of Bifidobacterium animalis subsp. lactis strain BLa80 in promoting growth and development (including gut microbiota and physical growth and development) of healthy infants and young children across different age groups, enhancing immune function, improving allergy incidence, and… Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Infant ALL
- What is being tested?
- Probiotic BLa80
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Jun 2024to 25 Sep 2024
- Phase
- Interventional
- 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 Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants and young children born at 37 to 42 weeks of gestation through both artificial breastfeeding, with a birth weight greater than or equal to 2500 g and less than 4000 g, regardless of gender
- Infants and young children whose mothers do not have diagnosed metabolic disorders such as diabetes and are not afflicted with communicable diseases such as hepatitis B or HIV
- Enrollment will be stratified into three age groups: 0-6 months, 6-12 months, and 12-36 months
- Consent from parents or primary caregivers of infants and young children to collect faecal samples during the study
- No clinically diagnosed allergic diseases at the time of enrolment (including but not limited to eczema, asthma, allergic colitis, allergic rhinitis, pollen allergies, etc.)
- Infants and young children with a medical record established at local maternal and child health care hospital's paediatrics department, undergoing regular check-ups, and following feeding advice and guidance from pediatricians
- Assurance from family members or primary caregivers not to administer additional probiotic products (including formula milk containing probiotics) to infants and young children during the intervention period.
Who cannot join
- Healthy infants and young children aged 0-6 months:
- Infants with a history of asphyxia at birth or a history of NICU hospitalization
- Infants born with congenital defects or abnormalities
- Infants whose mother had pregnancy-related conditions such as gestational hypertension, pre-eclampsia or eclampsia, gestational diabetes, cholestasis of pregnancy, or other high-risk obstetric factors, as well as a history of alcohol or drug abuse during pregnancy
- Infants who have used antibiotics within 2 weeks prior to enrollment
- Infants who have had specific diseases affecting growth and development within 1 month prior to enrollment (e.g., pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.)
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- Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
- Infants who have used investigational drugs or participated in other clinical studies before screening
- Infants who have consumed probiotic products within 1 month prior to enrollment (calculated from birth to enrollment for infants aged <1 month)
- Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
- Infants with known allergies to the ingredients of probiotic products
- Children who require hospitalization for treatment due to malnutrition
- Other reasons that researchers consider as unsuitable for participation in the clinical trial, such as those that could affect efficacy evaluation or individuals with poor compliance
- Infants and young children aged 6-12 months with good health
- Infants who have used antibiotics within 2 weeks prior to enrollment
- Infants who have had specific diseases affecting growth and development within the 1 month prior to enrollment (Infants who have had specific diseases affecting growth and development within 1 month prior to enrollment (e.g., pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.)
- Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
- Infants who have used investigational drugs or participated in other clinical studies within 3 months prior to screening
- Infants who have consumed probiotic products within 1 month prior to enrollment
- Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
- Infants with known allergies to the ingredients of probiotic products
- Children who require hospitalization for treatment due to malnutrition
- Other reasons that researchers consider as unsuitable for participation in the clinical trial, such as those that could affect efficacy evaluation or individuals with poor compliance
- Infants and young children aged 12-36 months with good health
- Infants who have used antibiotics within 2 weeks prior to enrollment
- Infants who have had specific diseases affecting growth and development within the 1 month prior to enrollment, such as pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.
- Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
- Infants who have used investigational drugs or participated in other clinical studies within 3 months prior to screening
- Infants who have consumed probiotic products within 1 month prior to enrollment
- Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
- Infants with known allergies to the ingredients of probiotic products
- Children who require hospitalization for treatment due to malnutrition
- Other reasons that researchers consider as unsuitable for participation in the clinical trial, such as those that could affect efficacy evaluation or individuals with poor compliance
Trial locations and contacts
1 site in 1 country.
Natalina Soesilawati, Dr. contact
Indonesia1 site
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta 10430, 10430
Natalina Soesilawati, +62 21 7695513, 7515932 ext. +62, ec_fkui@yahoo.com
About this study
Official title: Prospective, Placebo-Controlled, Randomized Double-Blind Clinical Study on the Intervention of Animal-Derived Probiotic in Infant Growth and Development, Allergy Incidence, and Immune Function
To evaluate the intervention effects of Bifidobacterium animalis subsp. lactis strain BLa80 in promoting growth and development (including gut microbiota and physical growth and development) of healthy infants and young children across different age groups, enhancing immune function, improving allergy incidence, and analyzing the safety of BLa80 in relation to infant growth and development, allergy incidence, and gut microbiota.
- Conditions
- Healthy, Infant ALL
- Being tested
- Probiotic BLa80, Placebo Maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic BLa80Dietary supplement
Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
Placebo MaltodextrinOther
Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic BLa80 | Experimental | Participants receive one sachet per day containing probiotic BLa80 and maltodextrin (Day 0 to Day 84). Receives: Dietary Supplement: Probiotic BLa80 |
| Maltodextrin | Placebo comparator | Participants receive one sachet per day containing maltodextrin only, serving as the placebo (Day 0 to Day 84). Receives: Other: Placebo Maltodextrin |
| Blank | No intervention | Participants in this arm will not receive any intervention or placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota
Collect patient fecal samples, test for 16S rRNA.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalina Soesilawati, Dr., Principal investigator, Karya Medika II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412042
- Sponsor's protocol ID
- WK2024006
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Placebo-Controlled, Randomized Double-Blind Clinical Study on the Intervention of Animal-Derived Probiotic in Infant Growth and Development, Allergy Incidence, and Immune Function
- ClinicalTrials.gov ID
- NCT06412042
- Acronym / sponsor ID
- WK2024006
- Conditions
- Healthy, Infant ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 14 May 2024 (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.
To evaluate the intervention effects of Bifidobacterium animalis subsp. lactis strain BLa80 in promoting growth and development (including gut microbiota and physical growth and development) of healthy infants and young children across different age groups, enhancing immune function, improving allergy incidence, and analyzing the safety of BLa80 in relation to infant growth and development, allergy incidence, and gut microbiota.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic BLa80 | Experimental | Dietary Supplement: Probiotic BLa80Participants receive one sachet per day containing probiotic BLa80 and maltodextrin (Day 0 to Day 84). |
| Maltodextrin | Placebo comparator | Other: Placebo MaltodextrinParticipants receive one sachet per day containing maltodextrin only, serving as the placebo (Day 0 to Day 84). |
| Blank | No intervention | –Participants in this arm will not receive any intervention or placebo. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy infants and young children born at 37 to 42 weeks of gestation through both artificial breastfeeding, with a birth weight greater than or equal to 2500 g and less than 4000 g, regardless of gender
- Infants and young children whose mothers do not have diagnosed metabolic disorders such as diabetes and are not afflicted with communicable diseases such as hepatitis B or HIV
- Enrollment will be stratified into three age groups: 0-6 months, 6-12 months, and 12-36 months
- Consent from parents or primary caregivers of infants and young children to collect faecal samples during the study
- No clinically diagnosed allergic diseases at the time of enrolment (including but not limited to eczema, asthma, allergic colitis, allergic rhinitis, pollen allergies, etc.)
Key exclusion criteria (33 listed)
- Healthy infants and young children aged 0-6 months:
- Infants and young children aged 6-12 months with good health
- Infants who have used antibiotics within 2 weeks prior to enrollment
- Infants who have had specific diseases affecting growth and development within the 1 month prior to enrollment (Infants who have had specific diseases affecting growth and development within 1 month prior to enrollment (e.g., pneumonia, severe diarrhea, severe constipation, severe cow's milk protein allergy, malnutrition, gastrointestinal surgery, severe congenital heart disease, epilepsy, cerebral palsy, developmental delay, confirmed genetic metabolic disorders, chromosomal disorders, genetic diseases, etc.)
- Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
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 |
|---|---|---|
| Probiotic BLa80Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation. | Dietary supplement | Probiotic BLa80 |
| Placebo MaltodextrinCollect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation. | Other | Maltodextrin |
Primary outcome
Changes in gut microbiota
Time frame: 84 days
Collect patient fecal samples, test for 16S rRNA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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.
Natalina Soesilawati, Dr. contact
Natalina Soesilawati, Dr. principal investigator
Karya Medika II Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic BLa80 in people with Healthy and Infant ALL, run by Wecare Probiotics Co., Ltd. at 1 site in Indonesia.
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 7 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 14 May 2024. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicky Achmad Ginanjar, bachelor (+62 21 7695513, 7515932 ext. +62, vicky.achmad@equilab-int.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota (time frame: 84 days). 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 14 May 2024.