Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05CH03
Study information
Scientific title
Acronym
PRONUT Study
Study hypothesis
In a population of severely malnourished children:
1. Low-milk/chickpea-based RUTF (Ready-to-Use Therapeutic Food) is non-inferior (one-sided equivalence hypothesis) to high-milk/peanut-based RUTF.
2. Probiotic/Prebiotic enhanced ('Synbiotic 2000 Forte') RUTF is superior to standard RUTF.
Due to a delay in the food acceptability pilot studies, the trial was simplified to test only the second hypothesis:
Probiotic/Prebiotic enhanced ('synbiotic 2000 Forte') RUTF is superior to standard RUTF.
Ethics approval
College of Medicine Research and Ethics Committee, Malawi (COMREC) (reference number: P03/04/236). Final approval, including amendments: 10th November 2005.
Simplification of study to test only second hypothesis approved April 2006.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
Severe acute malnutrition
Intervention
The initial plan was that after initial in-patient stabilisation with F75 milk, enrolled children would be randomised to one of four different types of RUTF:
1. (Control) Standard, high-milk/peanut based RUTF
2. Standard RUTF with added synbiotic
3. New formulation low-milk/chickpea-based RUTF
4. New formulation RUTF with added synbiotic
Due to delays in the food acceptability pilot studies, the trial was simplified prior to start, and as of beginning of enrolment in July 2006 is testing only:
1. (Control) Standard, high-milk/peanut based RUTF
2. Standard RUTF with added synbiotic
The simplified study started enrolling patients on 12th July 2006, and is expected to end in April 2007.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Nutritional cure (%)
Secondary outcome measures
1. Death rate (%)
2. Rate of weight gain (g/kg/day)
3. Incidence of illness episodes (including diarrhoea)
4. Length of stay in programme (days)
5. Default rate (%)
Overall trial start date
27/01/2006
Overall trial end date
27/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All children suffering from severe acute malnutrition (World Health Organisation [WHO] criteria: less than 70% weight/height and/or oedema) admitted to Moyo Malnutrition Ward, Queen Elizabeth Hospital, Blantyre, Malawi
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Initially 1200, after simplification this was changed to 800. Recruitment completed.
Participant exclusion criteria
1. Children with severe cerebral palsy or obvious dysmorphic syndrome
2. Children less than six months of age or 4 kg weight
Recruitment start date
27/01/2006
Recruitment end date
27/04/2007
Locations
Countries of recruitment
Malawi
Trial participating centre
Centre for International Child Health
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
Institute of Child Health, University College London (UK)
Sponsor details
30 Guildford Street
London
WC1N 1EH
United Kingdom
+ 44 (0)207 2429789
e.pendleton@ich.ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
At registration, prior to 23/07/09: Valid International (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Corrected on 23/07/09: the project was funded from a core grant from the Department for International Development (DFID) (UK) to Concern Worldwide (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19595348
Publication citations
-
Results
Kerac M, Bunn J, Seal A, Thindwa M, Tomkins A, Sadler K, Bahwere P, Collins S, Probiotics and prebiotics for severe acute malnutrition (PRONUT study): a double-blind efficacy randomised controlled trial in Malawi., Lancet, 2009, 374, 9684, 136-144, doi: 10.1016/S0140-6736(09)60884-9.