Maternal ExposurePhase 2BRAVENCT03851120
Brain Probiotic and LC-PUFA Intervention for Optimum Early Life
A Phase 2 study testing Probiotics and LC-PUFA (480 mg DHA) and Psychosocial stimulation and healthy eating education in people with Maternal Exposure and Health Behavior, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the beneficial gut microbiota colonization. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Exposure, Health Behavior, Infant Development
- What is being tested?
- Probiotics and LC-PUFA (480 mg DHA) and Psychosocial stimulation and healthy eating education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 1 siteIndonesia
- Study dates
- 31 Oct 2019to 31 Aug 2024
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each pregnant woman must meet all of the following criteria to be enrolled in this study:
- 1. Indonesian pregnant women in the 2nd trimester of gestational period 2. healthy pregnancy (as measured by hemoglobin level, pregnancy status, pregnancy history) 3. Having a normal blood pressure 4. Planning to stay in the study area until the child is 6 months old 5. Willing to sign informed consent 5. Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
- Child age above 24 months from the BRAVE intervention project
- Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
Who cannot join
- Each pregnant women meeting any of the following criteria will be excluded from the study:
- Having foreign objects in the body due to trauma, artificial heart value, metal objects or ferromagnetic (plate, screw, clip, prosthetic), and electronic device (pacemaker, cochlear implant, insulin pump), and being claustrophobic
- Having history of previous gestational diabetes or been diagnosed to have gestational diabetes
- Having history of type 1 and type 2 diabetes
- Severe anemia
- 1. Child being hospitalized during the study/data collection
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Human Nutrition Research Center, Indonesian Medical Education Research Institute; and Department of Nutrition, Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 13420
About this study
Official title: Promotion of Maternal Gut Microbiota and Psychological Stimulation on Child Cognitive Development at 6 Months of Age
Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the beneficial gut microbiota colonization. The discovery of the gut microbiota-brain axis suggested that there is a reciprocal influence between the brain and the gut through a constant communication. This bi-directional axis enables signals to be transferred from brain to influence sensory, motor, and secretory modalities of the GI tract, also permits signal from the gut to influence brain function. The establishment of intestinal microbiota during early neurodevelopmental period suggests the colonization and maturation of gut microbiota may influence brain development. Several studies have shown there is an association between shifts in the gut microbiota composition in children with neurodevelopmental disorders. This study aims to investigate how maternal probiotic + LC-PUFA supported with government program supplements, healthy eating, and psychosocial stimulation could affect fetal brain development and later child brain functions and cognitive development. Intervention would be delivered to pregnant women for 9 months, starting at the end of second trimester of gestational period.
Read the detailed description
Health and well-being at all ages is one of the goal set in the Sustainable Development Goals. Starting as early as possible has been considered to be an effective strategy for better investation in achieving healthy population. Therefore, the prevention and promotion of health and well being is starting to target population at younger age, starting as early as possible. Accordingly, the early life period of individuals has been considered as a critical period, especially in terms of the brain and cognitive development. The phases of brain development starts very early, starting from the fetal development in the uterus. The development process extends from early in the beginning of fetal development and lasted to the end, finishing last. The brain undergoes a period of rapid growth during the last trimester of fetal life and the first 2 years of childhood. Therefore, quality of pregnancy as well as quality of early life is important to the fetal brain development as well as later child brain function and cognitive development. In line with that notion, there are many studies suggesting that gut microbiota could affect CNS development through several ways, i.e. alteration of microbial composition, activation of immune system, changes in signaling via neural pathways, affecting tryptophan metabolism, modulating gut hormonal response and affecting hormonal signaling pathway, and releasing metabolites that could stimulate sympathetic nervous system. In particular, these studies have found bi-directional communication between the brain and the gut microbiota, referred to as the microbiota-gut-brain axis. The animal study showed that the gut microbiota regulates the development and function of the brain. Unfortunately, the study on human was still lacking.
This study is a randomized clinical trial (RCT) and placebo parallel controlled study, followed by a follow-up study at 2 years old. The research will be conducted in eight public hospitals / health care facilities in Indonesia, Jakarta.
In light of COVID-19 outbreak, if face-to-face activities are permitted by (1) national government (Indonesian Ministry of Health), (2) local government (DKI Jakarta), (3) the university, (4) Data Safety Monitoring Board, and (5) by consent of the subject, then the activities need to be strictly adjusted with the COVID-19 prevention measures for both personnel and subjects. All personnel and subjects who will be involved in the activities are required to fill out the COVID-19 symptom screening form prior to the visit.
Some adjustments for the project field implementation have been conducted during the outbreak, including:
- Following Good Clinical Practice, for the safety of the subjects and all the team members, we are now ensuring that the subjects gain benefits from their involvement in the BRAVE project by implementing routine COVID-19 screening, providing adequate PPE for the fieldworkers, and educating them about the prevention measures.
- Supplement delivery: Because we could not visit to the houses anymore due to staff restriction regulations, the bottles of the supplement are delivered using online motorcycle taxi services, and this includes the weighing scale for monthly monitoring. We have also developed a protocol to ensure the safety of supplement bottle transfer from the research personnel to the motorcycle taxi driver, and from the driver to the mothers, including safe distancing and disinfection procedures. We will also educate, provide a thermometer for self-temperature screening and provide the disinfectant to the mothers.
- Outcome assessment: As per March 19, MRI assessment and blood sample collection remained implemented at a non-COVID-19 referral hospital and laboratory, with strict safety procedures for the subjects and personnel. For mothers who do not feel comfortable visiting the hospital/laboratory, they are free to refuse these procedures.
- Compliance: Online system to promote and assess compliance. To maintain the quality, we cross-check mothers' activities by online assessment, interactive short message service (sms), and phone calls.
- New Subject Recruitment are less priority right now or potentially stop for the time being until the situation is getting better.
- Being tested
- Probiotics and LC-PUFA (480 mg DHA), Placebo probiotics and control LC-PUFA (120 mg DHA), Psychosocial stimulation and healthy eating education
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics and LC-PUFA (480 mg DHA)Dietary supplement
Probiotics and LC-PUFA (480 mg DHA)
Placebo probiotics and control LC-PUFA (120 mg DHA)Dietary supplement
Placebo probiotics and control LC-PUFA (120 mg DHA)
Psychosocial stimulation and healthy eating educationBehavioural
Psychosocial stimulation and healthy eating education
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 150 pregnant women will be given Probiotics and 480 mg DHA, psychosocial stimulation, and healthy eating education Receives: Dietary Supplement: Probiotics and LC-PUFA (480 mg DHA); Behavioral: Psychosocial stimulation and healthy eating education |
| Control | Placebo comparator | 150 pregnant women will be given placebo probiotics and 240 mg DHA, psychosocial stimulation, and healthy eating education Receives: Dietary Supplement: Placebo probiotics and control LC-PUFA (120 mg DHA); Behavioral: Psychosocial stimulation and healthy eating education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total brain volume
measured in parenchymal and cortical regions
Measured: 1 year
Fetal brain development
Myelination index
Measured: 1 year
Child cognitive at 4 months of age
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III); a higher score indicates better performance
Measured: 1 year
Brain function at 4 months of age
Brainstem Evoked Response Audiometry (BERA)
Measured: 1 year
Eye tracking tasks at 6 months of age
Visual paired comparison memory task and Infant Orienting with Attention task at 4 months of age
Measured: 1 year
Child cognitive at 6 months of age
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III); a higher score indicates better performance
Measured: 1 year
Secondary outcomes (36)
Mother depression scale
Mother's Depression Test; a lower score indicates better performance
Measured: 1 year
Birth weight
Baby weighing scale
Measured: 4 month
Child's Growth
Change in weight-for-age z-score
Measured: 6 months
Child's linear growth
Change in Length-for-age z-score
Measured: 6 months
Head circumference
Change in Head-circumference-for-age
Measured: 6 months
Child nutritional status
Change in weight-for-length z score
Measured: 6 months
Quality of interaction with parents
Maternal involvement using HOME inventory questionnaires
Measured: 1 year
Maternal blood micronutrient & macronutrient status
Zinc, iron, folate, omega-3 blood level
Measured: 1 year
Incidence of gestational diabetes
Based on blood glucose assessment
Measured: 1 year
Incidence of pre-eclampsia
Diagnosed by physician
Measured: 1 year
Incidence of preterm birth
Gestational age
Measured: 4 month
Mother's dietary quality
actual dietary intake, dietary pattern and quality
Measured: 1 year
Maternal fecal microbiota composition
Microbiota composition by S16rRNA analysis
Measured: 1 year
Child fecal microbiota composition
Microbiota composition by S16rRNA analysis
Measured: 4 months
Maternal omega-3 level in breast milk at 4 months of age
Omega-3 level assessment using Gas Chromatography-Mass Spectrometry
Measured: 1 year
Human milk oligosaccharides at 6 months of age
2-FL HMO assessment in breast milk
Measured: 1 year
Maternal glucagon-like peptide-1 (GLP-1) profile
GLP-1 assessment using enzyme-linked immunosorbent assay
Measured: 1 year
Maternal peptide-YY (PYY) profile
PYY assessment using enzyme-linked immunosorbent assay
Measured: 1 year
Maternal fecal short chain fatty acids (SCFAs)
SCFAs analysis using Gas Chromatography-Mass Spectrometry
Measured: 1 year
Child fecal short chain fatty acids
SCFAs analysis using Gas Chromatography-Mass Spectrometry
Measured: 1 year
Post-partum weight retention
Monthly changes in maternal weight
Measured: 1 year
Maternal weight circumference
Post-partum monthly changes in weight circumference
Measured: 1 year
Gestational weight gain
Changes in maternal height throughout pregnancy period
Measured: 1 year
Head circumference
Change in Head-circumference-for-age
Measured: 25 months
Mid-Upper Arm Circumference
Change in Mid-Upper Arm Circumference
Measured: 25 months
Toddler Body Weight
Toddler weighing scale
Measured: 25 months
Toddler Height
Toddler height measurement
Measured: 25 months
Mother Body weight
Mother's body weight
Measured: 1 year
Mother Depression Test
Mother depression score
Measured: 1 year
Mother Quality of Life
Mother quality of life score
Measured: 1 year
Maternal History of COVID-19 during follow-up
Frequency of COVID-19 case during the follow-up period
Measured: 2 years
Maternal Occurrence of COVID-19 during intervention period
Frequency of COVID-19 case during the intervention period
Measured: 1 year
Child cognitive at 25-28 months of age
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III); a higher score indicates better performance
Measured: 1 year
Eye tracking tasks at 25-28 months of age
Visual paired comparison memory task and Infant Orienting with Attention task at 24 months of age
Measured: 1 year
Mother Height
Mother's height
Measured: 1 year
Mother Fat Percentage
Mother's fat percentage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start31 Oct 2019
- Primary completion31 Aug 2022
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Maternal ExposureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Combination product: Probiotics and LC-PUFA The product will be given to 314 pregnant women, 157 pregnant women as an intervention group, and 157 pregnant women as a control group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Principal investigator, Prof Rina Agustina, MD, PhD, Universitas Indonesia
- Investigators
- Rina Agustina, PhD, Principal investigator, Human Nutrition Research Center, IMERI; Dep of Nutrition, Fac.of Medicine UI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851120
- Sponsor's protocol ID
- BRAVE
- Acronym
- BRAVE
- Status last verified
- Aug 2025
- First submitted
- 19 Feb 2019
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share Individual Participant Data (IPD) as stated in ClinicalTrial.gov registration. Data transfer to any third party will adhere to the ethical principles of the Declaration of Helsinki and comply with university regulations and the laws of the Republic of Indonesia, thereby upholding the rights of patients/subjects.
Publications
Sheridan PO, Bindels LB, Saulnier DM, Reid G, Nova E, Holmgren K, O'Toole PW, Bunn J, Delzenne N, Scott KP. Can prebiotics and probiotics improve therapeutic outcomes for undernourished individuals? Gut Microbes. 2014 Jan-Feb;5(1):74-82. doi: 10.4161/gmic.27252. Epub 2013 Dec 16.
PubMed 24637591Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027.
PubMed 27814521Naaktgeboren, C. Effect of maternal probiotic exposure during pregnancy and lactation on the mother and infant. International Journal of Probiotics and Prebiotics 5: 113-124, 2010
Ramakrishnan, U. A review of the benefits of nutrients supplements during pregnancy: from iron -folic-acid to long-chain polyunsaturated fatty acids to probiotics. Annales Nestle (English Ed): 29-40, 2010
Erlin M, Rianda D, Fadilah F, Erlina L, Rahayu MD, Prafiantini E, Sungkar A, Shankar AH, Agustina R. Association of Prepregnancy Body Mass Index with Gut Microbiota Diversity and Abundance in Pregnant Women. J Nutr. 2025 Jun;155(6):1731-1740. doi: 10.1016/j.tjnut.2025.02.006. Epub 2025 Feb 14.
PubMed 39956391
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Maternal Gut Microbiota and Psychological Stimulation on Child Cognitive Development at 6 Months of Age
- ClinicalTrials.gov ID
- NCT03851120
- Acronym / sponsor ID
- BRAVE / BRAVE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 22 Feb 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.
Probiotics is suggested to play several roles in promoting health, including alleviating disease symptoms, protection against atopic disease, and modulating the immune system by improving the beneficial gut microbiota colonization. The discovery of the gut microbiota-brain axis suggested that there is a reciprocal influence between the brain and the gut through a constant communication. This bi-directional axis enables signals to be transferred from brain to influence sensory, motor, and secretory modalities of the GI tract, also permits signal from the gut to influence brain function. The establishment of intestinal microbiota during early neurodevelopmental period suggests the colonization and maturation of gut microbiota may influence brain development. Several studies have shown there is an association between shifts in the gut microbiota composition in children with neurodevelopmental disorders. This study aims to investigate how maternal probiotic + LC-PUFA supported with government program supplements, healthy eating, and psychosocial stimulation could affect fetal brain development and later child brain functions and cognitive development. Intervention would be delivered to pregnant women for 9 months, starting at the end of second trimester of gestational period.
Detailed description
Health and well-being at all ages is one of the goal set in the Sustainable Development Goals. Starting as early as possible has been considered to be an effective strategy for better investation in achieving healthy population. Therefore, the prevention and promotion of health and well being is starting to target population at younger age, starting as early as possible. Accordingly, the early life period of individuals has been considered as a critical period, especially in terms of the brain and cognitive development. The phases of brain development starts very early, starting from the fetal development in the uterus. The development process extends from early in the beginning of fetal development and lasted to the end, finishing last. The brain undergoes a period of rapid growth during the last trimester of fetal life and the first 2 years of childhood. Therefore, quality of pregnancy as well as quality of early life is important to the fetal brain development as well as later child brain function and cognitive development. In line with that notion, there are many studies suggesting that gut microbiota could affect CNS development through several ways, i.e. alteration of microbial composition, activation of immune system, changes in signaling via neural pathways, affecting tryptophan metabolism, modulating gut hormonal response and affecting hormonal signaling pathway, and releasing metabolites that could stimulate sympathetic nervous system. In particular, these studies have found bi-directional communication between the brain and the gut microbiota, referred to as the microbiota-gut-brain axis. The animal study showed that the gut microbiota regulates the development and function of the brain. Unfortunately, the study on human was still lacking.
This study is a randomized clinical trial (RCT) and placebo parallel controlled study, followed by a follow-up study at 2 years old. The research will be conducted in eight public hospitals / health care facilities in Indonesia, Jakarta.
In light of COVID-19 outbreak, if face-to-face activities are permitted by (1) national government (Indonesian Ministry of Health), (2) local government (DKI Jakarta), (3) the university, (4) Data Safety Monitoring Board, and (5) by consent of the subject, then the activities need to be strictly adjusted with the COVID-19 prevention measures for both personnel and subjects. All personnel and subjects who will be involved in the activities are required to fill out the COVID-19 symptom screening form prior to the visit.
Some adjustments for the project field implementation have been conducted during the outbreak, including:
- Following Good Clinical Practice, for the safety of the subjects and all the team members, we are now ensuring that the subjects gain benefits from their involvement in the BRAVE project by implementing routine COVID-19 screening, providing adequate PPE for the fieldworkers, and educating them about the prevention measures.
- Supplement delivery: Because we could not visit to the houses anymore due to staff restriction regulations, the bottles of the supplement are delivered using online motorcycle taxi services, and this includes the weighing scale for monthly monitoring. We have also developed a protocol to ensure the safety of supplement bottle transfer from the research personnel to the motorcycle taxi driver, and from the driver to the mothers, including safe distancing and disinfection procedures. We will also educate, provide a thermometer for self-temperature screening and provide the disinfectant to the mothers.
- Outcome assessment: As per March 19, MRI assessment and blood sample collection remained implemented at a non-COVID-19 referral hospital and laboratory, with strict safety procedures for the subjects and personnel. For mothers who do not feel comfortable visiting the hospital/laboratory, they are free to refuse these procedures.
- Compliance: Online system to promote and assess compliance. To maintain the quality, we cross-check mothers' activities by online assessment, interactive short message service (sms), and phone calls.
- New Subject Recruitment are less priority right now or potentially stop for the time being until the situation is getting better.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Combination product: Probiotics and LC-PUFA The product will be given to 314 pregnant women, 157 pregnant women as an intervention group, and 157 pregnant women as a control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Probiotics and LC-PUFA (480 mg DHA), Behavioral: Psychosocial stimulation and healthy eating education150 pregnant women will be given Probiotics and 480 mg DHA, psychosocial stimulation, and healthy eating education |
| Control | Placebo comparator | Dietary Supplement: Placebo probiotics and control LC-PUFA (120 mg DHA), Behavioral: Psychosocial stimulation and healthy eating education150 pregnant women will be given placebo probiotics and 240 mg DHA, psychosocial stimulation, and healthy eating education |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Indonesian pregnant women in the 2nd trimester of gestational period 2. healthy pregnancy (as measured by hemoglobin level, pregnancy status, pregnancy history) 3. Having a normal blood pressure 4. Planning to stay in the study area until the child is 6 months old 5. Willing to sign informed consent 5. Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
- Child age above 24 months from the BRAVE intervention project
- Having a legally acceptable representative who is capable to understand the informed consent document and providing consent on the subject's behalf
Key exclusion criteria (6 listed)
- Each pregnant women meeting any of the following criteria will be excluded from the study:
- Having foreign objects in the body due to trauma, artificial heart value, metal objects or ferromagnetic (plate, screw, clip, prosthetic), and electronic device (pacemaker, cochlear implant, insulin pump), and being claustrophobic
- Having history of previous gestational diabetes or been diagnosed to have gestational diabetes
- Having history of type 1 and type 2 diabetes
- Severe anemia
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 |
|---|---|---|
| Probiotics and LC-PUFA (480 mg DHA)Probiotics and LC-PUFA (480 mg DHA) | Dietary supplement | Intervention |
| Placebo probiotics and control LC-PUFA (120 mg DHA)Placebo probiotics and control LC-PUFA (120 mg DHA) | Dietary supplement | Control |
| Psychosocial stimulation and healthy eating educationPsychosocial stimulation and healthy eating education | Behavioural | Control, Intervention |
Primary outcome
Total brain volume
Time frame: 1 year
measured in parenchymal and cortical regions
Fetal brain development
Time frame: 1 year
Myelination index
Child cognitive at 4 months of age
Time frame: 1 year
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III); a higher score indicates better performance
Brain function at 4 months of age
Time frame: 1 year
Brainstem Evoked Response Audiometry (BERA)
Eye tracking tasks at 6 months of age
Time frame: 1 year
Visual paired comparison memory task and Infant Orienting with Attention task at 4 months of age
Child cognitive at 6 months of age
Time frame: 1 year
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III); a higher score indicates better performance
36 secondary outcomes
Mother depression scale
Time frame: 1 year
Birth weight
Time frame: 4 month
Child's Growth
Time frame: 6 months
Child's linear growth
Time frame: 6 months
Head circumference
Time frame: 6 months
Child nutritional status
Time frame: 6 months
Quality of interaction with parents
Time frame: 1 year
Maternal blood micronutrient & macronutrient status
Time frame: 1 year
Incidence of gestational diabetes
Time frame: 1 year
Incidence of pre-eclampsia
Time frame: 1 year
Incidence of preterm birth
Time frame: 4 month
Mother's dietary quality
Time frame: 1 year
Maternal fecal microbiota composition
Time frame: 1 year
Child fecal microbiota composition
Time frame: 4 months
Maternal omega-3 level in breast milk at 4 months of age
Time frame: 1 year
Human milk oligosaccharides at 6 months of age
Time frame: 1 year
Maternal glucagon-like peptide-1 (GLP-1) profile
Time frame: 1 year
Maternal peptide-YY (PYY) profile
Time frame: 1 year
Maternal fecal short chain fatty acids (SCFAs)
Time frame: 1 year
Child fecal short chain fatty acids
Time frame: 1 year
Post-partum weight retention
Time frame: 1 year
Maternal weight circumference
Time frame: 1 year
Gestational weight gain
Time frame: 1 year
Head circumference
Time frame: 25 months
Mid-Upper Arm Circumference
Time frame: 25 months
Toddler Body Weight
Time frame: 25 months
Toddler Height
Time frame: 25 months
Mother Body weight
Time frame: 1 year
Mother Depression Test
Time frame: 1 year
Mother Quality of Life
Time frame: 1 year
Maternal History of COVID-19 during follow-up
Time frame: 2 years
Maternal Occurrence of COVID-19 during intervention period
Time frame: 1 year
Child cognitive at 25-28 months of age
Time frame: 1 year
Eye tracking tasks at 25-28 months of age
Time frame: 1 year
Mother Height
Time frame: 1 year
Mother Fat Percentage
Time frame: 1 year
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 29 Aug 2025.
- Background: PubMed 24637591Sheridan PO, Bindels LB, Saulnier DM, Reid G, Nova E, Holmgren K, O'Toole PW, Bunn J, Delzenne N, Scott KP. Can prebiotics and probiotics improve therapeutic outcomes for undernourished individuals? Gut Microbes. 2014 Jan-Feb;5(1):74-82. doi: 10.4161/gmic.27252. Epub 2013 Dec 16.
- Background: PubMed 27814521Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027.
- BackgroundNaaktgeboren, C. Effect of maternal probiotic exposure during pregnancy and lactation on the mother and infant. International Journal of Probiotics and Prebiotics 5: 113-124, 2010
- BackgroundRamakrishnan, U. A review of the benefits of nutrients supplements during pregnancy: from iron -folic-acid to long-chain polyunsaturated fatty acids to probiotics. Annales Nestle (English Ed): 29-40, 2010
- Derived from this study: PubMed 39956391Erlin M, Rianda D, Fadilah F, Erlina L, Rahayu MD, Prafiantini E, Sungkar A, Shankar AH, Agustina R. Association of Prepregnancy Body Mass Index with Gut Microbiota Diversity and Abundance in Pregnant Women. J Nutr. 2025 Jun;155(6):1731-1740. doi: 10.1016/j.tjnut.2025.02.006. Epub 2025 Feb 14.
- Individual participant dataSharing planned: No. No plan to share Individual Participant Data (IPD) as stated in ClinicalTrial.gov registration. Data transfer to any third party will adhere to the ethical principles of the Declaration of Helsinki and comply with university regulations and the laws of the Republic of Indonesia, thereby upholding the rights of patients/subjects.
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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.
Rina Agustina, PhD principal investigator
Human Nutrition Research Center, IMERI; Dep of Nutrition, Fac.of Medicine UI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotics and LC-PUFA (480 mg DHA) and Psychosocial stimulation and healthy eating education in people with Maternal Exposure and Health Behavior, run by Universitas Indonesia 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 4 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 29 Aug 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total brain volume (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03851120, which also lists 5 linked publications.
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 29 Aug 2025.