Severe MalnutritionSAMNCT02639416
Hypoallergenic and Anti-inflammatory Feeds in Malawian Children With Severe Acute Malnutrition (SAM)
A study testing Polymeric formula, Elemental formula and Standard management in people with Severe Malnutrition and Enteritis, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
Children with complicated severe acute malnutrition (SAM), such as inability to take adequate feeds, infection and diarrhoea, require in-patient management. Despite following a well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality often exceeds 20%. Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Severe Malnutrition, Enteritis
- What is being tested?
- Polymeric formula, Elemental formula and Standard management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Jan 2016to 11 Jan 2017
- 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 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-23 months
- SAM diagnosed according to WHO criteria: (Weight-for-height z score <-3 and/or mid-upper arm circumference <11.5 cms and/or nutritional oedema)
- Admitted to hospital because of SAM with medical complications or fails an appetite test
- Completed stabilization phase and entering the second phase in refeeding; the transition Phase
- Willing to stay on the ward for 2 weeks after the stabilization phase (travel expenses will be provided)
Who cannot join
- Specific cause of malnutrition (e.g. cerebral palsy, other organ disease)
- Sibling admitted with SAM at the same time
- Unwilling to stay on ward for at least 2 weeks
- Declined to give consent
- Participating in another study
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Moyo ward, Department of Paediatrics, Queen Elizabeth Central Hospital
Blantyre, Southern Region, Box 360
About this study
Official title: Hypoallergenic and Anti-inflammatory Feeds to Treat Intestinal Inflammation in Malawian Children With Severe Acute Malnutrition: A Pilot Randomized Controlled Clinical Trial (SAM)
Children with complicated severe acute malnutrition (SAM), such as inability to take adequate feeds, infection and diarrhoea, require in-patient management. Despite following a well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality often exceeds 20%. Amongst survivors discharged home, many subsequently die, have long-term poor growth or recurrence of SAM.
It has long been recognized that children with SAM have intestinal inflammation and that this persists despite management according to WHO guidelines. The inflammation is thought to result from increased exposure to microbial pathogens in the gut in areas with poor sanitation. The damaged lining of the intestine impairs food digestion and absorption, likely allows gut bacteria to enter the blood stream to cause sepsis and also exposes the gut immune cells to microbial and food antigens causing the inflammation to persist. Failure to treat the intestinal inflammation is likely to contribute to the poor response to treatment and poor long-term outcomes in many children with SAM.
Read more
The intestinal inflammation seen in SAM is very similar to that which occurs in food intolerance (e.g. intolerance to cow's milk protein) and inflammatory bowel disease. In these conditions, the inflammation is treated very effectively with hypoallergenic ("elemental") and anti-inflammatory ("polymeric") formulas. These are nutritionally complete feeds that have a similar composition to the feeds used for nutritional rehabilitation in SAM.
We aim to undertake a pilot study to see if an elemental and/or polymeric formula are tolerated by children with SAM and help to reduce intestinal inflammation. We also aim to learn more about the intestinal inflammation in general that occurs in SAM by observing carefully the effect of these specific formulae and to do in-depth metabolic analyses.
Read the detailed description
We will study children admitted to the Moyo ward at the Queen Elizabeth Central Hospital, Blantyre, Malawi with complicated SAM. Following informed consent, children will be recruited once they have completed the initial stabilisation phase of management and enter the transition phase to nutritional rehabilitation. They will be randomly allocated to one of 3 arms, either 1) standard feeds (F-100 and/or ready-to-use therapeutic feeds), 2) a polymeric therapeutic formula or 3) an elemental therapeutic formula. The alternative feeds will be supplemented with micronutrients to be equivalent in composition to F-100. All children will remain admitted to the ward for 2 weeks and receive exclusively the allocated formula. All other aspects of the management of SAM will follow current practice based on WHO guidelines.
- Conditions
- Severe Malnutrition, Enteritis
- Being tested
- Polymeric formula, Elemental formula, Standard management
- Keywords
- severe acute malnutrition, polymeric therapeutic formula, elemental therapeutic formula
- Medical subject headings
- Malnutrition, Enteritis, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymeric formulaDietary supplement
Polymeric formulae are recommended in the management of inflammatory bowel disease in children
Elemental formulaDietary supplement
Elemental formulae are recommended in cow's milk and other food intolerances in children.
Standard managementOther
Standard management with F-100 and/or RUTF
| Study group | Role | What they receive |
|---|---|---|
| Standard management | Active comparator | Standard management consists of F-100 and/or ready-to-use therapeutic food (RUTF) according to usual practice for 14 days Receives: Other: Standard management |
| Polymeric formula | Experimental | Exclusive polymeric formula supplemented with micronutrients in equivalent volume to F-100 for 14 days Receives: Dietary Supplement: Polymeric formula |
| Elemental formula | Experimental | Exclusive elemental formula supplemented with micronutrients in equivalent volume to F-100 for 14 days Receives: Dietary Supplement: Elemental formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal calprotectin
Validated marker of intestinal inflammation
Measured: 14 days
Secondary outcomes (4)
Days with diarrhoea
number of days with 3 or more loose/watery stools
Measured: 1-14 days
Weight gain
change in weight in g/kg/day
Measured: 1-14 days
Episodes of sepsis
Clinical diagnosis
Measured: 1-14 days
Death
number of children who die
Measured: 1-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start1 Jan 2016
- Primary completion11 Jan 2017
- Study completion11 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Kamuzu University of Health Sciences, Queen Elizabeth Central Hospital, Blantyre, Malawi
- Responsible party
- Sponsor
- Investigators
- Stephen J Allen, MD, Principal investigator, Liverpool School of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639416
- Sponsor's protocol ID
- 15.048
- Acronym
- SAM
- Status last verified
- Feb 2021
- First submitted
- 21 Dec 2015
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoallergenic and Anti-inflammatory Feeds to Treat Intestinal Inflammation in Malawian Children With Severe Acute Malnutrition: A Pilot Randomized Controlled Clinical Trial (SAM)
- ClinicalTrials.gov ID
- NCT02639416
- Acronym / sponsor ID
- SAM / 15.048
- Conditions
- Severe Malnutrition, Enteritis
- Keywords
- severe acute malnutrition, polymeric therapeutic formula, elemental therapeutic formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Toronto, Kamuzu University of Health Sciences, Queen Elizabeth Central Hospital, Blantyre, Malawi
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 11 Jan 2017 (actual)
- Study completion
- 11 Jan 2017 (actual)
- First posted
- 24 Dec 2015 (estimated)
- 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.
Children with complicated severe acute malnutrition (SAM), such as inability to take adequate feeds, infection and diarrhoea, require in-patient management. Despite following a well-established World Health Organisation (WHO) protocol, outcomes are poor. Case fatality often exceeds 20%. Amongst survivors discharged home, many subsequently die, have long-term poor growth or recurrence of SAM.
It has long been recognized that children with SAM have intestinal inflammation and that this persists despite management according to WHO guidelines. The inflammation is thought to result from increased exposure to microbial pathogens in the gut in areas with poor sanitation. The damaged lining of the intestine impairs food digestion and absorption, likely allows gut bacteria to enter the blood stream to cause sepsis and also exposes the gut immune cells to microbial and food antigens causing the inflammation to persist. Failure to treat the intestinal inflammation is likely to contribute to the poor response to treatment and poor long-term outcomes in many children with SAM.
The intestinal inflammation seen in SAM is very similar to that which occurs in food intolerance (e.g. intolerance to cow's milk protein) and inflammatory bowel disease. In these conditions, the inflammation is treated very effectively with hypoallergenic ("elemental") and anti-inflammatory ("polymeric") formulas. These are nutritionally complete feeds that have a similar composition to the feeds used for nutritional rehabilitation in SAM.
We aim to undertake a pilot study to see if an elemental and/or polymeric formula are tolerated by children with SAM and help to reduce intestinal inflammation. We also aim to learn more about the intestinal inflammation in general that occurs in SAM by observing carefully the effect of these specific formulae and to do in-depth metabolic analyses.
Detailed description
We will study children admitted to the Moyo ward at the Queen Elizabeth Central Hospital, Blantyre, Malawi with complicated SAM. Following informed consent, children will be recruited once they have completed the initial stabilisation phase of management and enter the transition phase to nutritional rehabilitation. They will be randomly allocated to one of 3 arms, either 1) standard feeds (F-100 and/or ready-to-use therapeutic feeds), 2) a polymeric therapeutic formula or 3) an elemental therapeutic formula. The alternative feeds will be supplemented with micronutrients to be equivalent in composition to F-100. All children will remain admitted to the ward for 2 weeks and receive exclusively the allocated formula. All other aspects of the management of SAM will follow current practice based on WHO guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard management | Active comparator | Other: Standard managementStandard management consists of F-100 and/or ready-to-use therapeutic food (RUTF) according to usual practice for 14 days |
| Polymeric formula | Experimental | Dietary Supplement: Polymeric formulaExclusive polymeric formula supplemented with micronutrients in equivalent volume to F-100 for 14 days |
| Elemental formula | Experimental | Dietary Supplement: Elemental formulaExclusive elemental formula supplemented with micronutrients in equivalent volume to F-100 for 14 days |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6-23 months
- SAM diagnosed according to WHO criteria: (Weight-for-height z score <-3 and/or mid-upper arm circumference <11.5 cms and/or nutritional oedema)
- Admitted to hospital because of SAM with medical complications or fails an appetite test
- Completed stabilization phase and entering the second phase in refeeding; the transition Phase
- Willing to stay on the ward for 2 weeks after the stabilization phase (travel expenses will be provided)
Key exclusion criteria (5 listed)
- Specific cause of malnutrition (e.g. cerebral palsy, other organ disease)
- Sibling admitted with SAM at the same time
- Unwilling to stay on ward for at least 2 weeks
- Declined to give consent
- Participating in another study
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 |
|---|---|---|
| Polymeric formulaPolymeric formulae are recommended in the management of inflammatory bowel disease in children | Dietary supplement | Polymeric formula |
| Elemental formulaElemental formulae are recommended in cow's milk and other food intolerances in children. | Dietary supplement | Elemental formula |
| Standard managementStandard management with F-100 and/or RUTF | Other | Standard management |
Primary outcome
Change in faecal calprotectin
Time frame: 14 days
Validated marker of intestinal inflammation
4 secondary outcomes
Days with diarrhoea
Time frame: 1-14 days
Weight gain
Time frame: 1-14 days
Episodes of sepsis
Time frame: 1-14 days
Death
Time frame: 1-14 days
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 25 Feb 2021.
- Individual participant dataSharing planned: Yes
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The Relapse to Acute Malnutrition Prevention (RAMP) Trial
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The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
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Opportunistic Pneumococcal Immunisation Trial in MALnutrition
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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.
Stephen J Allen, MD principal investigator
Liverpool School of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymeric formula, Elemental formula and Standard management in people with Severe Malnutrition and Enteritis, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
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 5 inclusion and 5 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 25 Feb 2021. 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 Malawi. 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 in faecal calprotectin (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2021.