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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
| Savica, Indonesia | UNKNOWN |
| Institute of Research for Development, France | OTHER_GOV |
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The purpose of this study is to assess the efficacy of treating children with severe acute malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or without rice bran.
Rice bran is a nutrient dense food ingredient with prebiotics and phytochemicals, as well as vitamins, fatty acids, and amino acids. The investigators will determine if the inclusion of rice bran to locally produced RUTFs will improve SAM treatment for children in Indonesia. This will be assessed by standard anthropometric measures and determining the modulation of the malnourished child's gut microbiome and metabolome. The study will also assess rates of relapse in the entire cohort.
This study will yield new information of direct importance and impact to public health nutrition and advance our knowledge and treatment of SAM in Indonesia. Investigation of the gut-microbiota metabolism following consumption of rice bran provided in RUTFs compared to RUTF without rice bran included will provide key mechanistic insights for repairing nutrient absorptive functions in the gut, sustaining gut health in treated children and inform long-term treatment solutions for SAM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ready-to-use therapeutic food, no rice bran (control/comparator) | Active Comparator | Randomized participants will receive a locally produced ready-to-use therapeutic food to be consumed daily. |
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| Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental) | Experimental | Randomized participants will receive a locally produced ready-to-use therapeutic food with 5% heat stabilized rice bran to be consumed daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ready-to-use therapeutic food with heat stabilized rice bran | Dietary Supplement | Children assigned to the experimental group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food that contains 5% heat stabilized rice bran. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by child weight. | This will be assessed by measures of: - Weight | Baseline, week 4, week 8, and week 16 |
| Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by mid-upper arm circumference. | This will be assessed by measures of: -Mid-upper arm circumference | Changes between baseline, week 4, week 8, and week 16 |
| Efficacy of the locally produced ready-to-use therapeutic food + heat stabilized rice bran as compared to locally produced ready-to-use therapeutic food alone in the treatment of severe acute malnutrition as determined by morbidity. | This will be assessed by measures of: - Morbidity (diarrhea, fever, vomiting, upper or lower respiratory infection) | Changes between baseline, week 4, week 8, and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool microbiota composition | Determine stool microbiota composition of infants in both arms over time using 16S rRNA sequencing and shotgun metagenomic sequencing. | Changes between baseline, week 4, week 8, and week 16 |
| Dried blood spot metabolite profile |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damayanti Soekarjo, PhD | Savica, Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Savica | Jember | East Java | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38000818 | Background | Weber AM, Barbazza S, Fauzi MD, Rachmadewi A, Zuhrina R, Putri FK, Campos Ponce M, Hoeven MV, Rimbawan R, Nasution Z, Giriwono PE, Wieringa FT, Soekarjo DD, Ryan EP. Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia. BMJ Open. 2023 Nov 24;13(11):e076805. doi: 10.1136/bmjopen-2023-076805. | |
| 42356224 |
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IRB approved study protocol and informed consent forms will be shared.
Protocol and informed consent will be shared after enrollment of the first 100 participants
Sharing access will be made available from the investigative team directly
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| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Control study arm: Locally produced Ready to use therapeutic food (RUTF)
Intervention study arm: Locally produced Ready to use therapeutic food plus rice bran (RUTF+RB)
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| Ready-to-use therapeutic food (no rice bran) | Dietary Supplement | Children assigned to the active comparator group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food (no rice bran). |
|
Dried blood spots will be analyzed for metabolites. |
| Changes between baseline, week 4, week 8, and week 16 |
| Relapse | Determine the number of participants that experience severe acute malnutrition relapse 4 weeks after the treatment/intervention has ended. | Week 16 (end of study) |
| Percent of children recovered | The number of children recovered in the 4 week treatment period will be determined as well as the time to recovery (days). | Baseline, week 4, week 8, and week 16 |
| Derived |
| Barbazza S, van der Hoeven M, Ponce MC, Weber AM, Fauzi MD, Soekarjo DD, Ryan EP, Fortin S, Wieringa FT. Addition of Prebiotic Rice Bran to Ready-to-Use Therapeutic Food Modulated Changes in Body Composition Only of 6-23-Month-Old Children During Treatment for Uncomplicated Acute Malnutrition: The Solutions to Enhance Health with Alternative Treatment (SEHAT) Study. Nutrients. 2026 Jun 6;18(12):1836. doi: 10.3390/nu18121836. |