Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-06-15
2024-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Probiotic BLa80
Participants receive one sachet per day containing probiotic BLa80 and maltodextrin (Day 0 to Day 84).
Probiotic BLa80
Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
Maltodextrin
Participants receive one sachet per day containing maltodextrin only, serving as the placebo (Day 0 to Day 84).
Placebo Maltodextrin
Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
Blank
Participants in this arm will not receive any intervention or placebo.
No interventions assigned to this group
Interventions
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Probiotic BLa80
Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
Placebo Maltodextrin
Collect baby fecal samples, test for 16S rRNA, and analyze changes in the gut microbiota before and after supplementation.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Enrollment will be stratified into three age groups: 0-6 months, 6-12 months, and 12-36 months
4. Consent from parents or primary caregivers of infants and young children to collect faecal samples during the study
5. No clinically diagnosed allergic diseases at the time of enrolment (including but not limited to eczema, asthma, allergic colitis, allergic rhinitis, pollen allergies, etc.)
6. 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
7. 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.
Exclusion Criteria
1. Infants with a history of asphyxia at birth or a history of NICU hospitalization
2. Infants born with congenital defects or abnormalities
3. 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
4. Infants who have used antibiotics within 2 weeks prior to enrollment
5. 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.)
6. Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
7. Infants who have used investigational drugs or participated in other clinical studies before screening
8. Infants who have consumed probiotic products within 1 month prior to enrollment (calculated from birth to enrollment for infants aged \<1 month)
9. Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
10. Infants with known allergies to the ingredients of probiotic products
11. Children who require hospitalization for treatment due to malnutrition
12. 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
1. Infants who have used antibiotics within 2 weeks prior to enrollment
2. 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.)
3. Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
4. Infants who have used investigational drugs or participated in other clinical studies within 3 months prior to screening
5. Infants who have consumed probiotic products within 1 month prior to enrollment
6. Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
7. Infants with known allergies to the ingredients of probiotic products
8. Children who require hospitalization for treatment due to malnutrition
9. 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
1. Infants who have used antibiotics within 2 weeks prior to enrollment
2. 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.
3. Infants with severe primary diseases affecting other important organs or systems such as the heart, liver, kidney, hematopoietic system, etc.
4. Infants who have used investigational drugs or participated in other clinical studies within 3 months prior to screening
5. Infants who have consumed probiotic products within 1 month prior to enrollment
6. Infants who have used immunosuppressive drugs (such as glucocorticoids, immunosuppressants) before enrollment
7. Infants with known allergies to the ingredients of probiotic products
8. Children who require hospitalization for treatment due to malnutrition
9. 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
36 Months
ALL
Yes
Sponsors
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Wecare Probiotics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Natalina Soesilawati, Dr.
Role: PRINCIPAL_INVESTIGATOR
Karya Medika II Hospital
Locations
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Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta 10430, Indonesia
Countries
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Central Contacts
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Natalina Soesilawati, Dr.
Role: CONTACT
Facility Contacts
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Other Identifiers
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WK2024006
Identifier Type: -
Identifier Source: org_study_id
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