Effects of Channa Striata Extract on Intestinal Inflammation and Nutritional Status in Malnutritional Toddlers After Albendazole Therapy in South Bangka District

NCT06933862 | Not Yet Recruiting

• 1 other identifier: MPuspaSari
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Malnourished Children

Keywords

snakehead fish extract; malnourished children; Calprotectin; striatin

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  three months after intervention

Secondary Outcomes (6)

• Concentrations of fecal calprotectin

  From enrollment to the end of treatment at 3 months

• Concentrations of Alpha 1 Anti Trypsin (AAT) levels in stool

  From enrollment to the end of treatment at 3 months

• Concentrations of amino acid in blood samples

  From enrollment to the end of treatment at 3 months

• Complete hematological profiles

  From enrollment to the end of treatment at 3 months

• Iron status levels

  From enrollment to the end of treatment at 3 months

Study Arms (2)

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

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.

Dietary Supplement: Placebo

Interventions

Striatin DIETARY_SUPPLEMENT

striation or placebo given for 90 days assigned to striatin

Malnourished: Striatin

Placebo DIETARY_SUPPLEMENT

placebo

Malnourished: Placebo

Eligibility Criteria

• Age: 17 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Dexa Medica Group: collaborator

Study Sites (2)

Indonesian territories

South Bangka Or Toboali, Bangka–Belitung Islands, 33783, Indonesia

Location

IMERI Faculty of Medicine Universitas Indonesia

Central Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (9)

• Snakehead Fish (Channa striata) and Its Biochemical Properties for Therapeutics and Health Benefits

  BACKGROUND

• Potential effect of Striatin (DLBS0333), a bioactive protein fraction isolated from Channa striata for wound treatment

  BACKGROUND

• 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.

  PMID: 9548618 BACKGROUND

• Li 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.

  PMID: 25742018 BACKGROUND

• Vaz 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.

  PMID: 29891218 BACKGROUND

• Semba 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.

  PMID: 27211567 BACKGROUND

• Endrinikapoulos 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.

  PMID: 37101818 BACKGROUND

• Mrimi 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.

  PMID: 35245314 BACKGROUND

• Lahav-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.

  PMID: 30592649 BACKGROUND

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Study Officials

• Taniawati Supali

  Indonesia University

  STUDY CHAIR

Central Study Contacts

Monica Puspa Sari

CONTACT

+62853-1198-0272; monica.puspasari@ukrida.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo controlled, Plasebo was made by PT Dexa Medica and randomization code was held by PT Dexa Medica.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory, Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 18, 2025
• Study Start: May 15, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)