Efficacy of Striatin in Malnourished Children

Universitas Sriwijaya

Status and phase: Enrolling; Phase 3

Conditions: Severe Acute Malnutrition

Treatments: Drug: Striatin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07089329

University of Sriwijaya

Details and patient eligibility

About

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:

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.

Full description

1. 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.
2. Informed consents will be given and drawn from mother or legal caregiver.
3. 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.
4. Block randomization will be conducted to allocate participants into two groups: intervention group who receive Striatin supplementation, and control group who receive placebo.
5. The intervention will be given for 14 days. Neither researchers nor participants aware of the type of intervention (Striatin or placebo).
6. 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.
7. 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.
8. Weight will be measured every three days, and any complaint or side effect that appeared will be recorded every day.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Severe acute malnutrition (SAM) children based on WHZ and/or MUAC
2. Consents are given by parents/caregivers.

Exclusion criteria

1. 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.
2. Subjects who require special anthropometric examinations (condition such as edema, organomegaly, amputation, cerebral palsy GMFCS > 2)
3. Children who have history of severe hypersensitivity to snakehead fish and/or cow's milk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Striatin

Experimental group

Description:

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.

Treatment:

Drug: Striatin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo