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.
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
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
Parallel
Striatin
Dietary supplementstriation or placebo given for 90 days assigned to striatin
Placebo
Dietary supplementplacebo
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.
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.
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.
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.
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
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
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Indonesia University
Lead sponsor
Fakultas Kedokteran Universitas Indonesia
Sponsor institution
Dexa Medica Group
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
