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Pancreatic exocrine replacement therapy in severely malnourished children

The OPTIMISM trial: pancreatic exocrine replacement therapy in severely malnourished children: a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57423639
Enrollment
100
Registered
2014-04-14
Start date
2014-02-10
Completion date
Unknown
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute malnutrition in children Nutritional, Metabolic, Endocrine

Interventions

Children are randomised to two groups: receiving pancreatic enzyme replacement therapy (PERT) or standard treatment. All children admitted to MOYO have a thick blood film examined for parasitaemia and

Sponsors

Emma Children's Hospital Foundation Support (Stichting Steun Emma Kinderziekenhuis AMC) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Severely malnourished children 2. Aged between 6 and 60 months 3. Admitted to MOYO House 4. Diagnosed with kwashiorkor, and/or marasmus (WHO criteria) 5. Both HIV positive and negative children

Exclusion criteria

Exclusion criteria: 1. Malaria (as proven by a positive blood smear) 2. Sepsis (i.e. circulatory failure) 3. Severe pneumonia, vomiting or severe diarrhoea 4. Those whose parent/guardian has not given consent

Design outcomes

Primary

MeasureTime frame
1. To compare the percentage of weight gain after 28 days of PERT with the current standard of care (calculated using the final weight at 28 days and the minimum weight during admission) 2. An additional 10% increase in weight will be considered clinically relevant

Secondary

MeasureTime frame
The differences after 28 days of PERT compared to the current standard of care with respect to: 1. Improvement in exocrine pancreatic function assessed by increased serum cationic and faecal elastase-1 levels 2. Decreased time on the ward in the PERT group 3. Overall mortality by 4 weeks in both groups

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026