Severe Acute MalnutritionPhase 2NCT05319717
Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition
A Phase 2 study testing Ready-to-use therapeutic food with heat stabilized rice bran and Ready-to-use therapeutic food (no rice bran) in people with Severe Acute Malnutrition, run by Colorado State University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Ready-to-use therapeutic food with heat stabilized rice bran and Ready-to-use therapeutic food (no rice bran)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2022to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition
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.
Read the 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.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Ready-to-use therapeutic food with heat stabilized rice bran, Ready-to-use therapeutic food (no rice bran)
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready-to-use therapeutic food with heat stabilized rice branDietary 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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Ready-to-use therapeutic food (no rice bran) |
| 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. Receives: Dietary Supplement: Ready-to-use therapeutic food with heat stabilized rice bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: Changes between baseline, week 4, week 8, and week 16
Secondary outcomes (4)
Stool microbiota composition
Determine stool microbiota composition of infants in both arms over time using 16S rRNA sequencing and shotgun metagenomic sequencing.
Measured: Changes between baseline, week 4, week 8, and week 16
Dried blood spot metabolite profile
Dried blood spots will be analyzed for metabolites.
Measured: 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.
Measured: 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).
Measured: Baseline, week 4, week 8, and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Dec 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, Savica, Indonesia, Institute of Research for Development, France
- Responsible party
- Principal investigator, Elizabeth P Ryan, Colorado State University
- Investigators
- Damayanti Soekarjo, PhD, Principal investigator, Savica, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319717
- Sponsor's protocol ID
- CSU IRB#:1823
- Status last verified
- Jun 2024
- First submitted
- 5 Feb 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IRB approved study protocol and informed consent forms will be shared.
Publications
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.
PubMed 38000818Barbazza 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.
PubMed 42356224
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition
- ClinicalTrials.gov ID
- NCT05319717
- Acronym / sponsor ID
- CSU IRB#:1823
- Conditions
- Severe Acute Malnutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, Savica, Indonesia, Institute of Research for Development, France
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Ready-to-use therapeutic food, no rice bran (control/comparator) | Active comparator | Dietary Supplement: Ready-to-use therapeutic food (no rice bran)Randomized participants will receive a locally produced ready-to-use therapeutic food to be consumed daily. |
| Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental) | Experimental | Dietary Supplement: Ready-to-use therapeutic food with heat stabilized rice branRandomized participants will receive a locally produced ready-to-use therapeutic food with 5% heat stabilized rice bran to be consumed daily. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready-to-use therapeutic food with heat stabilized rice branChildren 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. | Dietary supplement | Ready-to-use therapeutic food, with heat stabilized rice bran (Experimental) |
| Ready-to-use therapeutic food (no rice bran)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). | Dietary supplement | Ready-to-use therapeutic food, no rice bran (control/comparator) |
Primary outcome
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.
Time frame: Baseline, week 4, week 8, and week 16
This will be assessed by measures of: - Weight
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.
Time frame: Changes between baseline, week 4, week 8, and week 16
This will be assessed by measures of: -Mid-upper arm circumference
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.
Time frame: Changes between baseline, week 4, week 8, and week 16
This will be assessed by measures of: - Morbidity (diarrhea, fever, vomiting, upper or lower respiratory infection)
4 secondary outcomes
Stool microbiota composition
Time frame: Changes between baseline, week 4, week 8, and week 16
Dried blood spot metabolite profile
Time frame: Changes between baseline, week 4, week 8, and week 16
Relapse
Time frame: Week 16 (end of study)
Percent of children recovered
Time frame: Baseline, week 4, week 8, and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 38000818Weber 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.
- Derived from this study: PubMed 42356224Barbazza 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.
- Individual participant dataSharing planned: Yes. IRB approved study protocol and informed consent forms will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damayanti Soekarjo, PhD principal investigator
Savica, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ready-to-use therapeutic food with heat stabilized rice bran and Ready-to-use therapeutic food (no rice bran) in people with Severe Acute Malnutrition, run by Colorado State University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline, week 4, week 8, and week 16). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319717, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.