Severe Acute MalnutritionPhase 3NCT07089329
Efficacy of Striatin in Malnourished Children
A Phase 3 study testing Striatin in people with Severe Acute Malnutrition, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
This is a double-blind randomized-controlled clinical trial to identify the effect of Striatin (snakehead fish extract) supplementation in increasing body weight, improving acute inflammatory markers and microbiota profiles in children with severe acute malnutrition (SAM) treating with standard nutritional therapy. Read more about this study
- Who is it for?
- Ages 12 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Striatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 May 2025to 16 Apr 2026
- Phase
- Phase 3
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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Severe acute malnutrition (SAM) children based on WHZ and/or MUAC
- Consents are given by parents/caregivers.
Who cannot join
- SAM children with malignancy, liver cirrhosis, acute liver failure, severe kidney disorders, acute and chronic infections that attack the liver or other severe infections that require special treatment.
- Subjects who require special anthropometric examinations (condition such as edema, organomegaly, amputation, cerebral palsy GMFCS > 2)
- Children who have history of severe hypersensitivity to snakehead fish and/or cow's milk.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Community Health Center and Pediatric outpatient clinic at Mohammad Hoesin Hospital
Palembang, South Sumatra, 30000
About this study
Official title: Efficacy of Striatin on Weight Gain, Improvement of Acute Phase Inflammatory Marker, and the Change of Firmicutes Bacteroidetes (F/B), SCFA, BDNF Proteins in Malnourished Children: A Preliminary Study
This is a double-blind randomized-controlled clinical trial to identify the effect of Striatin (snakehead fish extract) supplementation in increasing body weight, improving acute inflammatory markers and microbiota profiles in children with severe acute malnutrition (SAM) treating with standard nutritional therapy.
The main questions to answer are:
Read more
Does Striatin supplementation effective in increasing body weight and improving acute inflammatory markers in SAM children? What are the adverse events of Striatin supplementation in SAM children?
Researchers will compare Striatin supplementation and placebo (a look-alike substance that contains no drug) to identify the increase of body weight, improvement of acute inflammatory markers and microbiota profiles.
Read the detailed description
- Children aged 12-59 months diagnosed with SAM based on weight-for-height Z score (WHZ) and/or mid-upper arm circumference (MUAC) will be included in the study.
- Informed consents will be given and drawn from mother or legal caregiver.
- Blood and stool samples will be taken before and after intervention in all participants. Markers which will be checked are: prealbumin, hsCRP, and brain-derived neurotropic factor (BDNF), from blood. Moreover, short-chain fatty acid (SCFA) and Bacteroides/Firmiculates ratio will be analyzed from stool.
- Block randomization will be conducted to allocate participants into two groups: intervention group who receive Striatin supplementation, and control group who receive placebo.
- The intervention will be given for 14 days. Neither researchers nor participants aware of the type of intervention (Striatin or placebo).
- Both groups will receive standard F-100 formula or oral nutrition therapy (ONS) as nutritional treatment for SAM, vitamin C, vitamin B complex, and folic acid.
- Intervention group will receive 1 sachet of Striatin and control group will receive 1 sachet of Placebo every 24 hours. Both Striatin and placebo will be dissolved in 10 ml of solvent syrup. The route of administration can be oral or via nasogastric tube.
- Weight will be measured every three days, and any complaint or side effect that appeared will be recorded every day.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Striatin, Placebo
- Keywords
- Striatin, Malnutrition, Acute inflammation markers, Microbiota, Children
- Medical subject headings
- Severe Acute Malnutrition, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StriatinDrug
Also called Inbumin Forte
Daily administration of Striatin extract will be carried out for 14 days. The dose is 1 sachet/day (5 g of Striatin) which dissolved in 10 mll of syrup.
PlaceboDrug
Daily administration of 1 sachet of placebo will be carried out for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Striatin | Experimental | Participant in the intervention group will consume 1 sachet of the study product daily for 14 days. Each sachet contains 5 g of Striatin extract and 0.25 g of curcumin, to be dissolved in 10 ml of solvent syrup. The product is white in powder form, has sweet taste, and turns into a light-orange liquid after dissolution. Receives: Drug: Striatin |
| Placebo | Placebo comparator | Participant in the control group will consume 1 sachet of Placebo daily for 14 days. Each sachet contains 4.89 g Mannitol, also to be dissolved in 10 ml of solvent syrup. The color and taste of the placebo match those of the intervention product to maintain blinding. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and relative weight increase
Weight in grams
Measured: Baseline, every three days, and Day 15.
The change of Prealbumin
Prealbumin level
Measured: Baseline and Day 15.
The change of hsCRP
hsCRP level
Measured: Baseline and Day 15.
Secondary outcomes (3)
The change of SCFA
Short chain fatty acids (SCFA)
Measured: Baseline and Day 15.
The change ofB/F ratio
Bacteroides-Firmicutes ratio (B/F ratio)
Measured: Baseline and Day 15.
Level of neurocognitive biomarker.
Brain Derived Neurotropic Factor (BDNF)
Measured: Baseline and Day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start20 May 2025
- Primary completion25 Feb 2026
- Study completion16 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a double-blind randomized controlled clinical trial to identify the effects of Striatin supplementation on weight, acute inflammation markers, and microbiota profiles of SAM children.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Collaborators
- Dexa Medica Group
- Responsible party
- Principal investigator, Moretta Damayanti Fauzi, MD, Universitas Sriwijaya
- Investigators
- Agrifina Helga, Bachelor, Study director, University of Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089329
- Sponsor's protocol ID
- University of Sriwijaya
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sigh S, Roos N, Chamnan C, Laillou A, Prak S, Wieringa FT. Effectiveness of a Locally Produced, Fish-Based Food Product on Weight Gain among Cambodian Children in the Treatment of Acute Malnutrition: A Randomized Controlled Trial. Nutrients. 2018 Jul 16;10(7):909. doi: 10.3390/nu10070909.
PubMed 30012981Puji Rahayu, Faustine Marcelline, Erna Sulistyaningrum, Maggy Thenawidjaja Suhartono, Raymond Rubianto Tjandrawinata, Potential effect of striatin (DLBS0333), a bioactive protein fraction isolated from Channa striata for wound treatment, Asian Pacific Journal of Tropical Biomedicine, Volume 6, Issue 12, 2016, Pages 1001-1007, ISSN 2221-1691, https://doi.org/10.1016/j.apjtb.2016.10.008. (https://www.sciencedirect.com/science/article/pii/S2221169115308534)