Malnourished ChildrenStriatin1NCT06933862
Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District
A study testing Striatin in people with Malnourished Children, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
The goal of this clinical trial is to learn if intervention with channa striata extract or inbumin forte sachet as a food supplement can improve intestinal damage and nutritional status in malnourished children aged 1.5-5 years. Read more about this study
- Who is it for?
- Ages 17 to 60 months
- Conditions the study is for
- Malnourished Children
- What is being tested?
- Striatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 2 sitesIndonesia
- Study dates
- 15 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Malnourished children aged 1.5-5 years (-3SD to < -2 SD)
- Parents or guardians are willing to participate in the study
- Parents or guardians can read and fill out the questionnaire
Who cannot join
- Children with chronic diseases such as tuberculosis, congenital heart disease, diabetes, cancer, epilepsy, HIV Aids, sickle cell anemia, and mental illness.
- Children with history of snakehead fish allergy
- Children with physical disabilities that complicate data collection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites
IMERI Faculty of Medicine Universitas Indonesia
Central Jakarta, DKI Jakarta, 10430
Indonesian territories
South Bangka Or Toboali, Bangka–Belitung Islands, 33783
Dinas Kesehatan, 0717-6242141, dinkes@babelprov.go.id
6285311980272
About this study
The goal of this clinical trial is to learn if intervention with channa striata extract or inbumin forte sachet as a food supplement can improve intestinal damage and nutritional status in malnourished children aged 1.5-5 years. The main questions it aims to answer are:
- Whether there is a change in calprotectin and AAT levels after administration of snakehead fish extract of inbumin forte sachet?
- Whether there is a difference in changes in nutritional status after administration of snakehead fish extract or inbumin forte sachet? Researchers will compare snakehead fish extract or inbumin forte sachet to a placebo (a look-alike substance that contains no drug) to see if snakehead fish extract or inbumin forte sachet works to treat children malnutrition.
Participants will take snakehead fish extract or inbumin forte sachet or placebo every day for 3 months. Researchers will visit study participants every month to check their weight and height and monitor vitamin administration through photos, notes and videos sent every day and records complaints or symptoms that may arise and at the end of 3 months, researchers will collect stool and blood samples and check nutritional status.
Read the detailed description
The study participants were malnourished children aged 1.5 to 5 years. Data on malnourished children were obtained from the local health department. Based on this data, participants were selected from several sub-districts with the highest malnutrition cases, including Toboali (Rias and Toboali villages), Payung, Air Gegas, and Batu Betumpang sub-districts. After invitations were sent to the participants, they were registered using their family registration card and assigned a queue number or research code. The study plan and research procedures were then explained to the participants. First, anthropometric measurements were conducted including weight and height, with the results entered into the WHO Anthro calculator (-3 SD to <-2 SD). Baseline blood samples were collected, and labeled stool sample bottles were distributed. Fresh stool samples were collected the next day at a designated location. A 100 mg portion of each stool sample was transferred into a 1.5 ml Eppendorf tube and stored in a -20°C freezer. Each sample was divided into two tubes: one for gut microbiota analysis and the other for AAT and calprotectin testing using ELISA. Additionally, the Kato-Katz method was used to examine fresh stool samples for helminth infections. Following stool sample collection, participants were given albendazole at the appropriate dosage. Blood sample analysis included a complete blood count, amino acid testing using filter paper, serum ferritin using mini Vidas immunology analyzer, serum iron, total iron-binding capacity (TIBC) using Vitros chemistry analyzer and serum retinol levels using ELISA. Two weeks after albendazole administration, stool samples were re-examined using Kato-Katz method to confirm the absence of helminth infection. Then, participants were randomly assigned in a double-blind manner into two groups: one receiving snakehead fish extract (Inbumin Forte) and the other receiving a placebo. Based on sample size calculations, a minimum of 98 participants was required, and accounting for a 20% dropout rate, the total sample size was set at 122 children. Data processing was conducted using SPSS. A univariate analysis was performed to determine data distribution on ratio, nominal, and ordinal scales. Categorical data (nominal and ordinal) were presented as frequencies and percentages. Normality tests for numerical data were conducted using the Kolmogorov-Smirnov test, with a normal distribution determined if p > 0.05. Normally distributed data were presented as mean and standard deviation, while non-normally distributed data were shown as median and range (minimum-maximum).
Bivariate analysis was conducted to determine whether there were significant differences in nutritional status, macronutrient and micronutrient levels, inflammatory markers, intestinal permeability, and gut microbiota between children receiving striatin protein supplementation and those receiving a placebo. A paired t-test was used if the data were normally distributed to analyze mean differences between the two groups. If the data were not normally distributed, a chi-square test or Mann-Whitney test was applied. The effect of striatin protein intake on the studied variables was assessed using linear regression analysis. The hypothesis test results were interpreted at a 95% confidence level (α = 0.05), with the null hypothesis (H₀) being rejected if p < 0.05.
- Conditions
- Malnourished Children
- Being tested
- Striatin, Placebo
- Keywords
- snakehead fish extract, malnourished children, Calprotectin, striatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StriatinDietary supplement
striation or placebo given for 90 days assigned to striatin
PlaceboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| Malnourished: Striatin | Experimental | Striatin or inbumin forte is given in the form of a 5 g dose of powder and 250 mg of curmicin. Striation or inbumin forte powder dissolved in 30 ml of drinking water and given one sachet per day, taken in the morning and evening after meals and given for 90 days Receives: Dietary Supplement: Striatin |
| Malnourished: Placebo | Placebo comparator | placebo of striatin containing 4.89 g of mannitol was given in powder form and dissolved in 30 ml of drinking water. Placebo of striatin was given one sachet per day, taken in the morning and evening after meals and given for 90 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-score (weight for age)
Z-score according to WHO antropometry that will be collected is based on weight for age. Body Weight in kg will be measured using a SECA brand weight scale. The differences between placebo and Inbumin Forte will be analysed after 3 months of treatment.
Measured: three months after intervention
z-score (height for age)
Z-score according to WHO antropometry that will be collected is based on height for age. Height in cm will be using SECA brand height scale. The differences between placebo and Inbumin Forte will be analysed after 3 months of treatment.
Measured: three months after intervention
Secondary outcomes (6)
Concentrations of fecal calprotectin
Calprotectin in stool samples were examined using ELISA (in mcg/g). The differences between placebo and Inbumin will be analysed at the end of 3 months.
Measured: From enrollment to the end of treatment at 3 months
Concentrations of Alpha 1 Anti Trypsin (AAT) levels in stool
Alpha 1 Anti Trypsin (AAT) levels in stool samples were examined using ELISA (mcg/g). The differences in the concentrations of AAT levels between placebo and Inbumin Forte groups will be analysed after 3 months of treatment.
Measured: From enrollment to the end of treatment at 3 months
Concentrations of amino acid in blood samples
Amino acids levels (µmol/l) in blood samples were examined using LC-MSMS. The differences of amino acid levels between placebo and Inbumin Forte will be analysed at the end of 3 months
Measured: From enrollment to the end of treatment at 3 months
Complete hematological profiles
Complete hematological profiles in blood samples were examined using sysmex analyzer. The differences between placebo and Inbumin will be analysed at the end of 3 months.Time Frame: From enrollment to the end of treatment at 3 months
Measured: From enrollment to the end of treatment at 3 months
Iron status levels
serum ferritin (ng/ml) were examined using mini vidas immunology analyzer, serum iron (µg/dL), total iron binding capacity (µg/dL) were examined using Vitros Chemistry analyzer. The differences between placebo and Inbumin will be analysed at the end of 3 months.Time Frame: From enrollment to the end of treatment at 3 months
Measured: From enrollment to the end of treatment at 3 months
Intestinal microbiota profiles
Intestinal microbiota were examined using PCR technique. The differences between placebo and Inbumin will be analysed at the end of 3 months.Time Frame: From enrollment to the end of treatment at 3 months
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start15 May 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Malnourished ChildrenStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study participants were divided into 2 groups namely group A which received snakehead fish extract or inbumin forte sachet and group B which received a placebo. The study was conducted randomly and double blinded.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Dexa Medica Group
- Responsible party
- Principal investigator, Monica Puspa Sari, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Taniawati Supali, Study chair, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933862
- Sponsor's protocol ID
- MPuspaSari
- Acronym
- Striatin1
- Status last verified
- Apr 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Snakehead Fish (Channa striata) and Its Biochemical Properties for Therapeutics and Health Benefits
Potential effect of Striatin (DLBS0333), a bioactive protein fraction isolated from Channa striata for wound treatment
Lisowska-Myjak B, Pachecka J, Sokrates O, Brzozowska-Binda A, Torbicka E. Fecal alpha-1-antitrypsin excretion in children with diarrhea. Scand J Gastroenterol. 1998 Mar;33(3):255-9. doi: 10.1080/00365529850170829.
PubMed 9548618Li F, Ma J, Geng S, Wang J, Liu J, Zhang J, Sheng X. Fecal calprotectin concentrations in healthy children aged 1-18 months. PLoS One. 2015 Mar 5;10(3):e0119574. doi: 10.1371/journal.pone.0119574. eCollection 2015.
PubMed 25742018Vaz Nery S, Bennett I, Clarke NE, Lin A, Rahman Z, Rahman M, Clements ACA. Characterisation of environmental enteropathy biomarkers and associated risk factors in children in the context of a WASH trial in Timor-Leste. Int J Hyg Environ Health. 2018 Jul;221(6):901-906. doi: 10.1016/j.ijheh.2018.05.012. Epub 2018 Jun 8.
PubMed 29891218Semba RD, Shardell M, Sakr Ashour FA, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Kraemer K, Khadeer MA, Ferrucci L, Manary MJ. Child Stunting is Associated with Low Circulating Essential Amino Acids. EBioMedicine. 2016 Apr;6:246-252. doi: 10.1016/j.ebiom.2016.02.030. Epub 2016 Feb 19.
PubMed 27211567Endrinikapoulos A, Afifah DN, Mexitalia M, Andoyo R, Hatimah I, Nuryanto N. Study of the importance of protein needs for catch-up growth in Indonesian stunted children: a narrative review. SAGE Open Med. 2023 Apr 17;11:20503121231165562. doi: 10.1177/20503121231165562. eCollection 2023.
PubMed 37101818Mrimi EC, Palmeirim MS, Minja EG, Long KZ, Keiser J. Malnutrition, anemia, micronutrient deficiency and parasitic infections among schoolchildren in rural Tanzania. PLoS Negl Trop Dis. 2022 Mar 4;16(3):e0010261. doi: 10.1371/journal.pntd.0010261. eCollection 2022 Mar.
PubMed 35245314Lahav-Ariel L, Caspi M, Nadar-Ponniah PT, Zelikson N, Hofmann I, Hanson KK, Franke WW, Sklan EH, Avraham KB, Rosin-Arbesfeld R. Striatin is a novel modulator of cell adhesion. FASEB J. 2019 Apr;33(4):4729-4740. doi: 10.1096/fj.201801882R. Epub 2018 Dec 28.
PubMed 30592649
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District
- ClinicalTrials.gov ID
- NCT06933862
- Acronym / sponsor ID
- Striatin1 / MPuspaSari
- Conditions
- Malnourished Children
- Keywords
- snakehead fish extract, malnourished children, Calprotectin, striatin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Dexa Medica Group
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Apr 2025 (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 learn if intervention with channa striata extract or inbumin forte sachet as a food supplement can improve intestinal damage and nutritional status in malnourished children aged 1.5-5 years. The main questions it aims to answer are:
- Whether there is a change in calprotectin and AAT levels after administration of snakehead fish extract of inbumin forte sachet?
- Whether there is a difference in changes in nutritional status after administration of snakehead fish extract or inbumin forte sachet? Researchers will compare snakehead fish extract or inbumin forte sachet to a placebo (a look-alike substance that contains no drug) to see if snakehead fish extract or inbumin forte sachet works to treat children malnutrition.
Participants will take snakehead fish extract or inbumin forte sachet or placebo every day for 3 months. Researchers will visit study participants every month to check their weight and height and monitor vitamin administration through photos, notes and videos sent every day and records complaints or symptoms that may arise and at the end of 3 months, researchers will collect stool and blood samples and check nutritional status.
Detailed description
The study participants were malnourished children aged 1.5 to 5 years. Data on malnourished children were obtained from the local health department. Based on this data, participants were selected from several sub-districts with the highest malnutrition cases, including Toboali (Rias and Toboali villages), Payung, Air Gegas, and Batu Betumpang sub-districts. After invitations were sent to the participants, they were registered using their family registration card and assigned a queue number or research code. The study plan and research procedures were then explained to the participants. First, anthropometric measurements were conducted including weight and height, with the results entered into the WHO Anthro calculator (-3 SD to <-2 SD). Baseline blood samples were collected, and labeled stool sample bottles were distributed. Fresh stool samples were collected the next day at a designated location. A 100 mg portion of each stool sample was transferred into a 1.5 ml Eppendorf tube and stored in a -20°C freezer. Each sample was divided into two tubes: one for gut microbiota analysis and the other for AAT and calprotectin testing using ELISA. Additionally, the Kato-Katz method was used to examine fresh stool samples for helminth infections. Following stool sample collection, participants were given albendazole at the appropriate dosage. Blood sample analysis included a complete blood count, amino acid testing using filter paper, serum ferritin using mini Vidas immunology analyzer, serum iron, total iron-binding capacity (TIBC) using Vitros chemistry analyzer and serum retinol levels using ELISA. Two weeks after albendazole administration, stool samples were re-examined using Kato-Katz method to confirm the absence of helminth infection. Then, participants were randomly assigned in a double-blind manner into two groups: one receiving snakehead fish extract (Inbumin Forte) and the other receiving a placebo. Based on sample size calculations, a minimum of 98 participants was required, and accounting for a 20% dropout rate, the total sample size was set at 122 children. Data processing was conducted using SPSS. A univariate analysis was performed to determine data distribution on ratio, nominal, and ordinal scales. Categorical data (nominal and ordinal) were presented as frequencies and percentages. Normality tests for numerical data were conducted using the Kolmogorov-Smirnov test, with a normal distribution determined if p > 0.05. Normally distributed data were presented as mean and standard deviation, while non-normally distributed data were shown as median and range (minimum-maximum).
Bivariate analysis was conducted to determine whether there were significant differences in nutritional status, macronutrient and micronutrient levels, inflammatory markers, intestinal permeability, and gut microbiota between children receiving striatin protein supplementation and those receiving a placebo. A paired t-test was used if the data were normally distributed to analyze mean differences between the two groups. If the data were not normally distributed, a chi-square test or Mann-Whitney test was applied. The effect of striatin protein intake on the studied variables was assessed using linear regression analysis. The hypothesis test results were interpreted at a 95% confidence level (α = 0.05), with the null hypothesis (H₀) being rejected if p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study participants were divided into 2 groups namely group A which received snakehead fish extract or inbumin forte sachet and group B which received a placebo. The study was conducted randomly and double blinded.
| Arm | Type | Receives |
|---|---|---|
| Malnourished: Striatin | Experimental | Dietary Supplement: StriatinStriatin or inbumin forte is given in the form of a 5 g dose of powder and 250 mg of curmicin. Striation or inbumin forte powder dissolved in 30 ml of drinking water and given one sachet per day, taken in the morning and evening after meals and given for 90 days |
| Malnourished: Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo of striatin containing 4.89 g of mannitol was given in powder form and dissolved in 30 ml of drinking water. Placebo of striatin was given one sachet per day, taken in the morning and evening after meals and given for 90 days. |
Who may qualify
- Ages
- 17 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Malnourished children aged 1.5-5 years (-3SD to < -2 SD)
- Parents or guardians are willing to participate in the study
- Parents or guardians can read and fill out the questionnaire
Key exclusion criteria (3 listed)
- Children with chronic diseases such as tuberculosis, congenital heart disease, diabetes, cancer, epilepsy, HIV Aids, sickle cell anemia, and mental illness.
- Children with history of snakehead fish allergy
- Children with physical disabilities that complicate data collection
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 |
|---|---|---|
| Striatinstriation or placebo given for 90 days assigned to striatin | Dietary supplement | Malnourished: Striatin |
| Placeboplacebo | Dietary supplement | Malnourished: Placebo |
Primary outcome
Z-score (weight for age)
Time frame: three months after intervention
Z-score according to WHO antropometry that will be collected is based on weight for age. Body Weight in kg will be measured using a SECA brand weight scale. The differences between placebo and Inbumin Forte will be analysed after 3 months of treatment.
z-score (height for age)
Time frame: three months after intervention
Z-score according to WHO antropometry that will be collected is based on height for age. Height in cm will be using SECA brand height scale. The differences between placebo and Inbumin Forte will be analysed after 3 months of treatment.
6 secondary outcomes
Concentrations of fecal calprotectin
Time frame: From enrollment to the end of treatment at 3 months
Concentrations of Alpha 1 Anti Trypsin (AAT) levels in stool
Time frame: From enrollment to the end of treatment at 3 months
Concentrations of amino acid in blood samples
Time frame: From enrollment to the end of treatment at 3 months
Complete hematological profiles
Time frame: From enrollment to the end of treatment at 3 months
Iron status levels
Time frame: From enrollment to the end of treatment at 3 months
Intestinal microbiota profiles
Time frame: From enrollment to the end of treatment at 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- BackgroundSnakehead Fish (Channa striata) and Its Biochemical Properties for Therapeutics and Health Benefits
- BackgroundPotential effect of Striatin (DLBS0333), a bioactive protein fraction isolated from Channa striata for wound treatment
- Background: PubMed 9548618Lisowska-Myjak B, Pachecka J, Sokrates O, Brzozowska-Binda A, Torbicka E. Fecal alpha-1-antitrypsin excretion in children with diarrhea. Scand J Gastroenterol. 1998 Mar;33(3):255-9. doi: 10.1080/00365529850170829.
- Background: PubMed 25742018Li F, Ma J, Geng S, Wang J, Liu J, Zhang J, Sheng X. Fecal calprotectin concentrations in healthy children aged 1-18 months. PLoS One. 2015 Mar 5;10(3):e0119574. doi: 10.1371/journal.pone.0119574. eCollection 2015.
- Background: PubMed 29891218Vaz Nery S, Bennett I, Clarke NE, Lin A, Rahman Z, Rahman M, Clements ACA. Characterisation of environmental enteropathy biomarkers and associated risk factors in children in the context of a WASH trial in Timor-Leste. Int J Hyg Environ Health. 2018 Jul;221(6):901-906. doi: 10.1016/j.ijheh.2018.05.012. Epub 2018 Jun 8.
- Background: PubMed 27211567Semba RD, Shardell M, Sakr Ashour FA, Moaddel R, Trehan I, Maleta KM, Ordiz MI, Kraemer K, Khadeer MA, Ferrucci L, Manary MJ. Child Stunting is Associated with Low Circulating Essential Amino Acids. EBioMedicine. 2016 Apr;6:246-252. doi: 10.1016/j.ebiom.2016.02.030. Epub 2016 Feb 19.
- Background: PubMed 37101818Endrinikapoulos A, Afifah DN, Mexitalia M, Andoyo R, Hatimah I, Nuryanto N. Study of the importance of protein needs for catch-up growth in Indonesian stunted children: a narrative review. SAGE Open Med. 2023 Apr 17;11:20503121231165562. doi: 10.1177/20503121231165562. eCollection 2023.
- Background: PubMed 35245314Mrimi EC, Palmeirim MS, Minja EG, Long KZ, Keiser J. Malnutrition, anemia, micronutrient deficiency and parasitic infections among schoolchildren in rural Tanzania. PLoS Negl Trop Dis. 2022 Mar 4;16(3):e0010261. doi: 10.1371/journal.pntd.0010261. eCollection 2022 Mar.
- Background: PubMed 30592649Lahav-Ariel L, Caspi M, Nadar-Ponniah PT, Zelikson N, Hofmann I, Hanson KK, Franke WW, Sklan EH, Avraham KB, Rosin-Arbesfeld R. Striatin is a novel modulator of cell adhesion. FASEB J. 2019 Apr;33(4):4729-4740. doi: 10.1096/fj.201801882R. Epub 2018 Dec 28.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Taniawati Supali study chair
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Striatin in people with Malnourished Children, run by Universitas Indonesia at 2 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Puspa Sari (+62853-1198-0272, monica.puspasari@ukrida.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Z-score (weight for age) (time frame: three months after intervention). The study lists 2 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 NCT06933862, which also lists 9 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 18 Apr 2025.