Severe Acute Malnutrition
Conditions
Keywords
Striatin, Malnutrition, Acute inflammation markers, Microbiota, Children
Brief 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. 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.
Detailed 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.
Interventions
DRUGStriatin
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.
DRUGPlacebo
Daily administration of 1 sachet of placebo will be carried out for 14 days.
Sponsors
Universitas Sriwijaya
Dexa Medica Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
We use block randomization (http://www.randomization.com) to allocate the participants into intervention or placebo. The participants will receive a sequentially-numbered, opaque, sealed envelope (SNOSE) which each sealed envelope is given a sequential number according to the order of recruitment and it contains the randomization code. Pharmacists are responsible for the distribution of the SNOSE and intervention products.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Months to 59 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute and relative weight increase | Baseline, every three days, and Day 15. | Weight in grams |
| The change of Prealbumin | Baseline and Day 15. | Prealbumin level |
| The change of hsCRP | Baseline and Day 15. | hsCRP level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of SCFA | Baseline and Day 15. | Short chain fatty acids (SCFA) |
| The change ofB/F ratio | Baseline and Day 15. | Bacteroides-Firmicutes ratio (B/F ratio) |
| Level of neurocognitive biomarker. | Baseline and Day 15. | Brain Derived Neurotropic Factor (BDNF) |
Countries
Indonesia
Contacts
STUDY_DIRECTORAgrifina Helga, Bachelor
University of Sriwijaya
Outcome results
None listed