Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/12/2005
Date assigned
23/01/2006
Last edited
23/07/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Seal

ORCID ID

Contact details

Centre for International Child Health
Institute of Child Health
30 Guildford Street
London
WC1N 1EH
United Kingdom

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

http://www.ucl.ac.uk

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

  1. 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.

Additional files

Editorial Notes