Clinical trial NCT05319717: Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition
Official title: Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Severe Acute Malnutrition
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: Savica, Indonesia
name: Institute of Research for Development, France
First posted: 2022-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study, with parent(s) signing the informed consent. If the caretaker denies the participation of the child, the child will be enrolled for treatment through the health system, but the information will be not considered for the purpose of the trial.
* Child identified with a weight-for-height z-score WHZ of \< -2.5 (SAM children and children with advanced moderate acute malnutrition) and/or mid-upper arm circumference (MUAC) \<115 mm) or a child with mild to moderate nutritional edema (regardless of anthropometry).
* Being qualified for outpatient treatment.
* Aged 6-59 months old upon enrolment
* Pass appetite test (taste test) (as stipulated by WHO guidelines on the treatment of SAM). See appetite test document attached.
* Not having consumed RUTF in the last two months

Exclusion Criteria:

* Children detected with severe acute malnutrition younger than 6 months of age will be excluded from the project, as well as any child with a body weight \<4.0 kg.
* Children 6-59 months old who, when diagnosed with SAM, have been detected with medical complications, with TB, HIV positive status, one or more signs from the Integrated Management of Childhood Illness (IMCI) guidelines, severe oedema (+++) or who have failed the appetite test (see appetite test document attached).
* Medical complications include: Cough/difficulty in breathing; Diarrhea; Fever; Ear Problems. IMCI signs will be identified according to WHO definition and include not able to drink or breastfeed; vomiting; convulsions; lethargy.
* Participating in another clinical trial
* Any congenital disorder that interferes with normal nutrient intake; chronic conditions including but not exclusively disorders of heart, kidney or liver (children to be screened by a physician).
* SAM with complications requiring hospital treatment. (Upon discharge from hospital, the child will be re-evaluated for inclusion in the study).
* Siblings will not be allowed to participate in the trial

Withdrawal criteria:

* Not consuming the RUTF supplementation at all in \>4 days a week in 2 consecutive weeks.
* Not providing samples or completing forms/questionnaires at study visits
* Developing medical complications requiring hospitalization
* Not gaining weight after 1 month of treatment
* Major reactions to intervention

Primary outcomes:
measure: 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.
timeFrame: Baseline, week 4, week 8, and week 16
measure: 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.
timeFrame: Changes between baseline, week 4, week 8, and week 16
measure: 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.
timeFrame: Changes between baseline, week 4, week 8, and week 16
Secondary outcomes:
measure: Stool microbiota composition
timeFrame: Changes between baseline, week 4, week 8, and week 16
measure: Dried blood spot metabolite profile
timeFrame: Changes between baseline, week 4, week 8, and week 16
measure: Relapse
timeFrame: Week 16 (end of study)
measure: Percent of children recovered
timeFrame: Baseline, week 4, week 8, and week 16
Other outcomes:
Locations:
city: Jember
country: Indonesia
facility: Savica
state: East Java
Study officials:
affiliation: Savica, Indonesia
name: Damayanti Soekarjo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.