Malnutrition, ChildNCT04334538
Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition
A study testing S-RUTF and oat RUTF in people with Malnutrition, Child, run by Washington University School of Medicine at 1 site in Sierra Leone.
Trial summary
Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- S-RUTF and oat RUTF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSierra Leone
- Study dates
- 2 Mar 2021to 6 Sep 2021
- Phase
- Interventional
- 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
- mid-upper arm circumference (MUAC) <11.5 cm
Who cannot join
- Children currently involved in another research trial or feeding program
- Children developmentally delayed
- have a chronic debilitating illness
- history of peanut or milk allergy
Trial locations and contacts
1 site in 1 country.
About this study
Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.
- Conditions
- Malnutrition, Child
- Being tested
- S-RUTF, oat RUTF
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-RUTFDietary supplement
Children will receive approximately 175 kcal/kg/d of standard ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
oat RUTFDietary supplement
Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
| Study group | Role | What they receive |
|---|---|---|
| S-RUTF | Active comparator | Children will receive approximately 175 kcal/kg/d of standard ready to use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. Receives: Dietary Supplement: S-RUTF |
| oat-RUTF | Experimental | Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. Receives: Dietary Supplement: oat RUTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of % of lactose excreted between enrollment and 4 weeks after enrollment
%L measured in the urine relative to the amount ingested will be calculated for children in both groups. %L will be categorized as normal (<0.2%) and abnormal (>0.2)
Measured: at week 4 after enrollment
Secondary outcomes (1)
fecal 16S rRNA configuration after 4 weeks of feeding
Multi amplicon rRNA characterization of flash frozen stool sample
Measured: after 4 weeks of feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start2 Mar 2021
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Project Peanut Butter, Sierra Leone, Ministry of Health and Sanitation, Sierra Leone
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334538
- Sponsor's protocol ID
- 202003153
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hendrixson DT, Naskidashvili N, Stephenson KB, Laury ML, Koroma AS, Manary MJ. An Alternative Oat-Containing, Ready-To-Use, Therapeutic Food Does Not Alter Intestinal Permeability or the 16S Ribosomal RNA Fecal Microbiome Configuration Among Children With Severe Malnutrition in Sierra Leone: A Randomized Controlled Trial. J Nutr. 2023 Jan 14;152(12):2744-2753. doi: 10.1093/jn/nxac207.
PubMed 36055798
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT04334538
- Acronym / sponsor ID
- 202003153
- Conditions
- Malnutrition, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Project Peanut Butter, Sierra Leone, Ministry of Health and Sanitation, Sierra Leone
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 6 Apr 2020 (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.
Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-RUTF | Active comparator | Dietary Supplement: S-RUTFChildren will receive approximately 175 kcal/kg/d of standard ready to use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. |
| oat-RUTF | Experimental | Dietary Supplement: oat RUTFChildren will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- mid-upper arm circumference (MUAC) <11.5 cm
Key exclusion criteria (4 listed)
- Children currently involved in another research trial or feeding program
- Children developmentally delayed
- have a chronic debilitating illness
- history of peanut or milk allergy
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 |
|---|---|---|
| S-RUTFChildren will receive approximately 175 kcal/kg/d of standard ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. | Dietary supplement | S-RUTF |
| oat RUTFChildren will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. | Dietary supplement | oat-RUTF |
Primary outcome
Change of % of lactose excreted between enrollment and 4 weeks after enrollment
Time frame: at week 4 after enrollment
%L measured in the urine relative to the amount ingested will be calculated for children in both groups. %L will be categorized as normal (<0.2%) and abnormal (>0.2)
1 secondary outcome
fecal 16S rRNA configuration after 4 weeks of feeding
Time frame: after 4 weeks of feeding
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 10 Aug 2022.
- Derived from this study: PubMed 36055798Hendrixson DT, Naskidashvili N, Stephenson KB, Laury ML, Koroma AS, Manary MJ. An Alternative Oat-Containing, Ready-To-Use, Therapeutic Food Does Not Alter Intestinal Permeability or the 16S Ribosomal RNA Fecal Microbiome Configuration Among Children With Severe Malnutrition in Sierra Leone: A Randomized Controlled Trial. J Nutr. 2023 Jan 14;152(12):2744-2753. doi: 10.1093/jn/nxac207.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-RUTF and oat RUTF in people with Malnutrition, Child, run by Washington University School of Medicine at 1 site in Sierra Leone.
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 1 inclusion and 4 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 10 Aug 2022. 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 Sierra Leone. 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.
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?
Change of % of lactose excreted between enrollment and 4 weeks after enrollment (time frame: at week 4 after enrollment). 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 NCT04334538, which also lists 1 linked publication.
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 10 Aug 2022.