Evidence map›Paper›PMID 38000818›Full record

ArticleBMJ open2023

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.

Annika M Weber, Silvia Barbazza, Moretta D Fauzi, Asrinisa Rachmadewi, Ririh Zuhrina, Fildzah K Putri, Maiza Campos Ponce, Marinka van der Hoeven, Rimbawan Rimbawan, Zuraidah Nasution and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05319717 (Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05319717 phase2completednot on this map

Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition

TypeinterventionalSponsorColorado State UniversityRan2022 to 2023Enrolled200ConditionsSevere Acute MalnutritionArmsReady-to-use therapeutic food with heat stabilized rice bran, Ready-to-use therapeutic food (no rice bran)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Annika M WeberDepartment of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado, USA.ORCID 0000-0002-7234-879X
Silvia BarbazzaDepartment of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Moretta D FauziDepartment of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Asrinisa RachmadewiSavica, Jakarta, Indonesia.
Ririh ZuhrinaSavica, Jakarta, Indonesia.
Fildzah K PutriSavica, Jakarta, Indonesia.
Maiza Campos PonceDepartment of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Marinka van der HoevenDepartment of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.ORCID 0000-0003-0566-6592
Rimbawan RimbawanSouth East Asia Food and Agriculture Science and Technology (SEAFAST) Center, Bogor Agricultural University, Bogor, Indonesia.
Zuraidah NasutionSouth East Asia Food and Agriculture Science and Technology (SEAFAST) Center, Bogor Agricultural University, Bogor, Indonesia.
Puspo E GiriwonoSouth East Asia Food and Agriculture Science and Technology (SEAFAST) Center, Bogor Agricultural University, Bogor, Indonesia.
Frank T WieringaInstitut de Recherche pour le Développement (IRD), Montpellier, France.
Damayanti D SoekarjoSavica, Jakarta, Indonesia E.P.Ryan@colostate.edu dama.soekarjo@savica.co.id.
Elizabeth P RyanDepartment of Environmental & Radiological Health Sciences, Colorado State University, Fort Collins, Colorado, USA E.P.Ryan@colostate.edu dama.soekarjo@savica.co.id.ORCID 0000-0002-1577-0919

Funding

CSU Infectious Disease Research and Response Training ProgramT32AI162691 · NIAID · COLORADO STATE UNIVERSITY · PI DEAN, GREGG A · 2021 to 2025
$2.1M
NIAID NIH HHS T32 AI162691
6 · The paper itself

Abstract

introductionCurrent formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes. METHODS AND ANALYSIS: A total of 200 children aged 6-59 months with uncomplicated SAM (weight-for-height z-scores (WHZ) <-3, or mid-upper arm circumference (MUAC) <115 mm or having bilateral pitting oedema +/++) or approaching SAM (WHZ<-2.5) will be enrolled in a double-blinded, randomised controlled trial. Children in the active control arm will receive a locally produced RUTF; those in the intervention arm will receive the local RUTF with 5% rice bran. Children will receive daily RUTF treatment for 8 weeks and be monitored for 8 weeks of follow-up. Primary outcomes include the effectiveness of RUTF as measured by changes in weight, WHO growth z-scores, MUAC and morbidity. Secondary outcomes include modulation of the gut microbiome and dried blood spot metabolome, the percentage of children recovered at weeks 8 and 12, and malnutrition relapse at week 16. An intention-to-treat analysis will be conducted for each outcome. ETHICS AND DISSEMINATION: The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647. TRIAL REGISTRATION NUMBER: NCT05319717.

Indexed as

Gastrointestinal MicrobiomeMalnutritionOryzaSevere Acute MalnutritionChildFast FoodsHumansIndonesiaInfantRandomized Controlled Trials as TopicTreatment OutcomeWeight GainCommunity child healthNutritionNUTRITION & DIETETICSProtocols & guidelinesPUBLIC HEALTH

Identifiers

PMID38000818
PMCPMC10680013

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.