Children, OnlyPhase 1NCT06044376
Ingestion Effect of Formula Milk With Triple Bifidobacteria Strains on Fecal Quality and Metabolites in Healthy Children
A Phase 1 study testing Formula milk with triple Bifidobacterium probiotic strain and Formula milk in people with Children, Only, run by Gadjah Mada University at 10 sites in Indonesia.
Trial summary
The goal of this clinical trial is to compare healthy children between 1 to 3 years old. The main question it aims to answer is 1. Is there an effect towards fecal quality after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and… Read more about this study
- Who is it for?
- Ages 12 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Children, Only
- What is being tested?
- Formula milk with triple Bifidobacterium probiotic strain and Formula milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 10 sitesIndonesia
- Study dates
- 2 May 2023to 31 Mar 2024
- Phase
- Phase 1
- 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 12 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 12 - 36 months
- Normal nutritional status (z-score height-for-age or z-score weight-for-height: -2 SD < X < 2 SD)
- Has no dairy allergies
- Does not consume breastmilk anymore during the intervention period
- Willing to participate through the whole research period
- Obtain consent from parents or guardians by signing the informed consent form
Who cannot join
- Has a history of lactose intolerance, congenital and chronic diseases including irritable bowel syndrome, etc.
- Receive antibiotic or other probiotic supplementation during the 14 day of baseline period.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Indonesia10 sites
PAUD Hiber Rotowijayan
Yogyakarta, Special Region of Yogyakarta, 55132
Paud Kunir Ceria Tegalgendu Kotagede
Yogyakarta, Special Region of Yogyakarta, 55172
Puskesmas Mlati 2
Yogyakarta, 55286
Paud Bodeh
Yogyakarta, 55294
Paud Gamping Lor
Yogyakarta, 55294
Paud Matahari Mejing 3
Yogyakarta, 55294
Paud Pereng Dawe
Yogyakarta, 55295
Paud Pereng Kembang
Yogyakarta, 55295
Paud Sembung
Yogyakarta, 55295
Paud Sumber
Yogyakarta, 55295
About this study
Official title: The Consumption Effect of Formula Milk With Triple Bifidobacteria Strains (Bifidobacterium Longum BB536, Bifidobacterium Breve M-16V, and Bifidobacterium Longum Subsp. Infantis M-63) on Fecal Quality and Metabolites in Healthy Children
The goal of this clinical trial is to compare healthy children between 1 to 3 years old. The main question it aims to answer is
- Is there an effect towards fecal quality after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
- Is there an effect towards short-chain fatty acid composition after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
- Is there an effect towards clinical profile after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
Read more
The clinical trial period started off with all the participants consuming a milk formula three times a day, for 14 days as a baseline period. Afterwards, the participants were randomly assigned to one of two groups: probiotic and placebo. Following the baseline period, participants in the probiotic group consumed formulated milk supplemented with the triple Bifidobacteria strains, while the placebo group ingested the same formulated milk without adding triple Bifidobacteria strains for 90 days.
Researchers will compare the probiotic and placebo groups to see if there are any effects towards the fecal quality, short-chain fatty acid level and clinical profile after consuming the milk formula.
Read the detailed description
This clinical trial is a study of 3 strains of Bifidobacterium was conducted in infants aged 1-3 years in Indonesia. The general objective of this study was to determine the benefits of combined supplementation of Bifidobacteria strains (B. longum BB536, B. breve M-16V, and B. longum subsp. infantis M-63) in healthy children aged 1-3 years. The study is conducted for 104 days with a baseline period of 14 days and continued with an intervention period of 90 days. Participants is divided into two groups, which are the intervention group and the placebo group. The study will be conducted using a double-blind randomized, placebo-controlled trial design. A total of 100 participants will be selected based on inclusion and exclusion criteria.
During the screening period (day 0), socialization of the research and signing of informed consent will be carried out for participants who are willing to participate. Participants were asked not to consume fermented milk products, probiotics and prebiotic fortified food/drinks while participating in research activities.
During the baseline period (Day 14), the participants were asked to consume control milk and, represented by their parents, were also asked to fill out research diaries in the form of diet records, records of probiotic products and prebiotic fortified food/drinks consumed, type and frequency of bowel movements, health complaints felt (discomfort, headaches, stomachaches, respiratory tract-related illnesses and fever), medication consumption records, days where the participants refused to eat. Participants were asked to collect research documents and collect stool samples on day 14 +/- 1.
During the intervention period, from day 15 to day 104, participants consumed 36 grams of the test product or placebo dissolved in 180 ml per serving with a consumption frequency of 3 times per day. Product consumption will be recorded in the product consumption logbook and on the subject's diary record form. Once every 2 weeks a health profile measurement (weight, height, arm circumference, head circumference, skinfold thickness) and sleep quality will be measured. Participants were asked to collect research documents and stool samples on day 104 +/- 1 with the same procedure as in the baseline period.
- Conditions
- Children, Only
- Being tested
- Formula milk with triple Bifidobacterium probiotic strain, Formula milk
- Keywords
- Children, Fecal sample, Triple Bifidobacterium strains, Probiotic, Formula milk, Indonesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula milk with triple Bifidobacterium probiotic strainCombination product
Formula milk with triple Bifidobacterium strain containing Bifidobacterium longum BB536 (6.9 x 10^7 CFU/serving), Bifidobacterium breve M16-V (6.9 x 10^7 CFU/serving), Bifidobacterium longum subsp. infantis M-63 (6.9 x 10^7 CFU/serving).
Formula milkOther
Formula milk without any addition of probiotic strain
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Active comparator | During the baseline period, all participants consumed milk formula without any addition of probiotics three servings per day for 14 days. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water.
The participants in the probiotic group consumed milk formula added with triple Bifidobacterium strain containing Bifidobacterium longum BB536 (6.9 x 10^7 CFU/serving), Bifidobacterium breve M16-V (6.9 x 10^7 CFU/serving), Bifidobacterium longum subsp. infantis M-63 (6.9 x 10^7 CFU/serving). The milk formula is consumed three servings per day for 90 days during the intervention period. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water. Receives: Combination Product: Formula milk with triple Bifidobacterium probiotic strain |
| Placebo Group | Placebo comparator | During the research period (both baseline and intervention period), all participants consumed milk formula without any addition of probiotics three servings per day for 104 days. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water. Receives: Other: Formula milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal characteristics
Observed the shape, color and consistency of fecal samples that will be combined to be reported as fecal type according to the Bristol Stool Chart
Measured: Before and after intervention period (day 13 and day 105)
Fecal pH
The pH of obtained fecal samples were measured using potential of hydrogen (pH) meter
Measured: Before and after intervention period (day 13 and day 105)
Bacterial colony characteristics
From the fecal samples obtained, direct plating using the selective media for Bifidobacterium (Bifidobacterium Selective Medium or BSM) and Enterobacteriaceae (MacConkey Agar) is conducted. Colony bacterial characterization is based on the cell morphology and Gram strain characteristics under the microscope.
Measured: Before and after intervention period (day 13 and day 105)
Bifidobacterium's cell count
The cell number is a total of Bifidobacteria cells obtained from DNA extraction of stool samples counted using quantitative PCR (qPCR). Cell count will be expressed in colony forming unit per gram (CFU/g).
Measured: Before and after intervention period (day 13 and day 105)
Enterobactericaeae's cell count
The cell number is a total of Enterobacteriaceae's cells obtained from DNA extraction of stool samples counted using quantitative PCR (qPCR). Cell count will be expressed in colony forming unit per gram (CFU/g)
Measured: Before and after intervention period (day 13 and day 105)
Short chain fatty acids analysis
The analysis includes the measurement of acetate, propionate, and butyrate. The analysis uses gas chromatography method.
Measured: Before and after intervention period (day 13 and day 105)
Biomarker of immune systems
The analysis on immune systems' biomarker uses the fecal water obtained from diluting the fecal samples into phosphate buffer. The fecal water is then added with protease inhibitor to keep fecal samples stable during the analysis. The immune system analyzed are interleukin 6 (IL6), interleukin 8 (IL8), interleukin 10 (IL10) and secretory immunoglobulin A (SIgA). All immune systems are read using the enzyme-linked Immunosorbent Assay (ELISA) Reader BioRad iMark.
Measured: Before and after intervention period (day 13 and day 105)
Secondary outcomes (17)
Defecation frequency records
Participants, represented by their parents or guardian, record their defecation frequency in a daily record.
Measured: Everyday during the research period (104 days)
Dietary pattern records
Participants, represented by their parents or guardian, record their dietary patterns in a daily record. The dietary pattern recorded includes type and portion of the foods, snacks and beverages.
Measured: Four days every two weeks, consists of two weekdays and two weekend days during the research period
Health complaint and medical records
Participants, represented by their parents or guardian, record their health complaint and medical records in a daily record.
Measured: Everyday during the research period (104 days)
Health profile record
Participants, represented by their parents or guardian, filled a questionnaire about recent respiratory health conditions.
Measured: Before and after intervention period (day 13 and day 105)
Gastrointestinal disorder record
Participants, represented by their parents or guardian, filled a questionnaire about recent gastrointestinal health conditions.
Measured: Before and after intervention period (day 13 and day 105)
Sleep quality
Participants, represented by their parents or guardian, filled a questionnaire about recent history of the participant's sleep quality.
Measured: Before and after intervention period (day 13 and day 105)
Behaviour assesment
Participants, represented by their parents or guardian, filled a questionnaire about how the participants behave especially how they express their emotions.
Measured: Before and after intervention period (day 13 and day 105)
Development screening
Participants, represented by their parents or guardian, filled a questionnaire about recent gastrointestinal health conditions. The Ages and Questionnaires (ASQ-3) were used based on the participant's current age.
Measured: Before and after intervention period (day 13 and day 105)
Psychosocial problems
Participants, represented by their parents or guardian, filled a questionnaire about possible psychosocial problems. The Pediatric Symptom Checklist (PSC) was used for this measure.
Measured: Before and after intervention period (day 13 and day 105)
Weight
The participants were measured for their weight in kilograms.
Measured: Once every two weeks for 105 days
Height
The participants were measured for their height in cm.
Measured: Once every two weeks for 105 days
Body Mass Index (BMI)
The measurement of weight and height were combined into BMI and expressed in kg/m^2
Measured: Once every two weeks for 105 days
Arm circumference
The participants were measured for their arm circumference in cm.
Measured: Once every two weeks for 105 days
Head circumference
The participants were measured for their head circumference in cm.
Measured: Once every two weeks for 105 days
Subcutaneous fat thickness
The participants were measured for their subcutaneous fat thickness in mm.
Measured: Once every two weeks for 105 days
Triceps thickness
The participants were measured for their triceps thickness in mm.
Measured: Once every two weeks for 105 days
Medical check up
An on-site medical professional will check the health condition of the participant.
Measured: Once every two weeks for 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 May 2023
- Primary completion9 Nov 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- PT Kalbe Farma Tbk, Morinaga Milk Industry Co., LTD
- Responsible party
- Principal investigator, Endang Sutriswati Rahayu, Gadjah Mada University
- Investigators
- Endang Sutriswati Rahayu, Prof. Dr. Ir, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044376
- Sponsor's protocol ID
- PUIPTProbiotikUGM_P002
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available to other researchers. During the screening period, all participants' guardian signed informed consent that states the data will not be shared to others aside from the current researcher and sponsors in the study.
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
- The Consumption Effect of Formula Milk With Triple Bifidobacteria Strains (Bifidobacterium Longum BB536, Bifidobacterium Breve M-16V, and Bifidobacterium Longum Subsp. Infantis M-63) on Fecal Quality and Metabolites in Healthy Children
- ClinicalTrials.gov ID
- NCT06044376
- Acronym / sponsor ID
- PUIPTProbiotikUGM_P002
- Conditions
- Children, Only
- Keywords
- Children, Fecal sample, Triple Bifidobacterium strains, Probiotic, Formula milk, Indonesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- PT Kalbe Farma Tbk, Morinaga Milk Industry Co., LTD
- Study start
- 2 May 2023 (actual)
- Primary completion
- 9 Nov 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 21 Sep 2023 (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 goal of this clinical trial is to compare healthy children between 1 to 3 years old. The main question it aims to answer is
- Is there an effect towards fecal quality after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
- Is there an effect towards short-chain fatty acid composition after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
- Is there an effect towards clinical profile after consuming milk formula supplemented with the triple Bifidobacteria strains (Bifidobacterium longum BB536, Bifidobacterium breve M-16V, and Bifidobacterium longum subsp. infantis M-63)?
The clinical trial period started off with all the participants consuming a milk formula three times a day, for 14 days as a baseline period. Afterwards, the participants were randomly assigned to one of two groups: probiotic and placebo. Following the baseline period, participants in the probiotic group consumed formulated milk supplemented with the triple Bifidobacteria strains, while the placebo group ingested the same formulated milk without adding triple Bifidobacteria strains for 90 days.
Researchers will compare the probiotic and placebo groups to see if there are any effects towards the fecal quality, short-chain fatty acid level and clinical profile after consuming the milk formula.
Detailed description
This clinical trial is a study of 3 strains of Bifidobacterium was conducted in infants aged 1-3 years in Indonesia. The general objective of this study was to determine the benefits of combined supplementation of Bifidobacteria strains (B. longum BB536, B. breve M-16V, and B. longum subsp. infantis M-63) in healthy children aged 1-3 years. The study is conducted for 104 days with a baseline period of 14 days and continued with an intervention period of 90 days. Participants is divided into two groups, which are the intervention group and the placebo group. The study will be conducted using a double-blind randomized, placebo-controlled trial design. A total of 100 participants will be selected based on inclusion and exclusion criteria.
During the screening period (day 0), socialization of the research and signing of informed consent will be carried out for participants who are willing to participate. Participants were asked not to consume fermented milk products, probiotics and prebiotic fortified food/drinks while participating in research activities.
During the baseline period (Day 14), the participants were asked to consume control milk and, represented by their parents, were also asked to fill out research diaries in the form of diet records, records of probiotic products and prebiotic fortified food/drinks consumed, type and frequency of bowel movements, health complaints felt (discomfort, headaches, stomachaches, respiratory tract-related illnesses and fever), medication consumption records, days where the participants refused to eat. Participants were asked to collect research documents and collect stool samples on day 14 +/- 1.
During the intervention period, from day 15 to day 104, participants consumed 36 grams of the test product or placebo dissolved in 180 ml per serving with a consumption frequency of 3 times per day. Product consumption will be recorded in the product consumption logbook and on the subject's diary record form. Once every 2 weeks a health profile measurement (weight, height, arm circumference, head circumference, skinfold thickness) and sleep quality will be measured. Participants were asked to collect research documents and stool samples on day 104 +/- 1 with the same procedure as in the baseline period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Active comparator | Combination Product: Formula milk with triple Bifidobacterium probiotic strainDuring the baseline period, all participants consumed milk formula without any addition of probiotics three servings per day for 14 days. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water. The participants in the probiotic group consumed milk formula added with triple Bifidobacterium strain containing Bifidobacterium longum BB536 (6.9 x 10^7 CFU/serving), Bifidobacterium breve M16-V (6.9 x 10^7 CFU/serving), Bifidobacterium longum subsp. infantis M-63 (6.9 x 10^7 CFU/serving). The milk formula is consumed three servings per day for 90 days during the intervention period. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water. |
| Placebo Group | Placebo comparator | Other: Formula milkDuring the research period (both baseline and intervention period), all participants consumed milk formula without any addition of probiotics three servings per day for 104 days. One serving of milk formula consists of 36 gram that is diluted in 180 mL lukewarm water. |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 12 - 36 months
- Normal nutritional status (z-score height-for-age or z-score weight-for-height: -2 SD < X < 2 SD)
- Has no dairy allergies
- Does not consume breastmilk anymore during the intervention period
- Willing to participate through the whole research period
Key exclusion criteria (2 listed)
- Has a history of lactose intolerance, congenital and chronic diseases including irritable bowel syndrome, etc.
- Receive antibiotic or other probiotic supplementation during the 14 day of baseline period.
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 |
|---|---|---|
| Formula milk with triple Bifidobacterium probiotic strainFormula milk with triple Bifidobacterium strain containing Bifidobacterium longum BB536 (6.9 x 10^7 CFU/serving), Bifidobacterium breve M16-V (6.9 x 10^7 CFU/serving), Bifidobacterium longum subsp. infantis M-63 (6.9 x 10^7 CFU/serving). | Combination product | Probiotic Group |
| Formula milkFormula milk without any addition of probiotic strain | Other | Placebo Group |
Primary outcome
Fecal characteristics
Time frame: Before and after intervention period (day 13 and day 105)
Observed the shape, color and consistency of fecal samples that will be combined to be reported as fecal type according to the Bristol Stool Chart
Fecal pH
Time frame: Before and after intervention period (day 13 and day 105)
The pH of obtained fecal samples were measured using potential of hydrogen (pH) meter
Bacterial colony characteristics
Time frame: Before and after intervention period (day 13 and day 105)
From the fecal samples obtained, direct plating using the selective media for Bifidobacterium (Bifidobacterium Selective Medium or BSM) and Enterobacteriaceae (MacConkey Agar) is conducted. Colony bacterial characterization is based on the cell morphology and Gram strain characteristics under the microscope.
Bifidobacterium's cell count
Time frame: Before and after intervention period (day 13 and day 105)
The cell number is a total of Bifidobacteria cells obtained from DNA extraction of stool samples counted using quantitative PCR (qPCR). Cell count will be expressed in colony forming unit per gram (CFU/g).
Enterobactericaeae's cell count
Time frame: Before and after intervention period (day 13 and day 105)
The cell number is a total of Enterobacteriaceae's cells obtained from DNA extraction of stool samples counted using quantitative PCR (qPCR). Cell count will be expressed in colony forming unit per gram (CFU/g)
Short chain fatty acids analysis
Time frame: Before and after intervention period (day 13 and day 105)
The analysis includes the measurement of acetate, propionate, and butyrate. The analysis uses gas chromatography method.
Biomarker of immune systems
Time frame: Before and after intervention period (day 13 and day 105)
The analysis on immune systems' biomarker uses the fecal water obtained from diluting the fecal samples into phosphate buffer. The fecal water is then added with protease inhibitor to keep fecal samples stable during the analysis. The immune system analyzed are interleukin 6 (IL6), interleukin 8 (IL8), interleukin 10 (IL10) and secretory immunoglobulin A (SIgA). All immune systems are read using the enzyme-linked Immunosorbent Assay (ELISA) Reader BioRad iMark.
17 secondary outcomes
Defecation frequency records
Time frame: Everyday during the research period (104 days)
Dietary pattern records
Time frame: Four days every two weeks, consists of two weekdays and two weekend days during the research period
Health complaint and medical records
Time frame: Everyday during the research period (104 days)
Health profile record
Time frame: Before and after intervention period (day 13 and day 105)
Gastrointestinal disorder record
Time frame: Before and after intervention period (day 13 and day 105)
Sleep quality
Time frame: Before and after intervention period (day 13 and day 105)
Behaviour assesment
Time frame: Before and after intervention period (day 13 and day 105)
Development screening
Time frame: Before and after intervention period (day 13 and day 105)
Psychosocial problems
Time frame: Before and after intervention period (day 13 and day 105)
Weight
Time frame: Once every two weeks for 105 days
Height
Time frame: Once every two weeks for 105 days
Body Mass Index (BMI)
Time frame: Once every two weeks for 105 days
Arm circumference
Time frame: Once every two weeks for 105 days
Head circumference
Time frame: Once every two weeks for 105 days
Subcutaneous fat thickness
Time frame: Once every two weeks for 105 days
Triceps thickness
Time frame: Once every two weeks for 105 days
Medical check up
Time frame: Once every two weeks for 105 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No. No individual participant data will be made available to other researchers. During the screening period, all participants' guardian signed informed consent that states the data will not be shared to others aside from the current researcher and sponsors in the study.
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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.
Endang Sutriswati Rahayu, Prof. Dr. Ir principal investigator
Gadjah Mada University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Formula milk with triple Bifidobacterium probiotic strain and Formula milk in people with Children, Only, run by Gadjah Mada University at 10 sites 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 6 inclusion and 2 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 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 10 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Fecal characteristics (time frame: Before and after intervention period (day 13 and day 105)). The study lists 7 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.