Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201805003381361 Date of Approval: 12/05/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Modifying Intestinal integrity and MicroBiome in severe Malnutrition with LEgume-based feeds
Official scientific title Modifying Intestinal Integrity and MicroBiome in severe Malnutrition with LEgume-based feeds [MIMBLE Study]: A Pilot Study
Brief summary describing the background and objectives of the trial Changes in intestinal mucosal integrity and gut microbial balance occur in severe malnutrition1 resulting in treatment failure and adverse clinical outcomes.2,3 Both gram-negative sepsis and diarrhoea are common co-morbidities and are key risk factors for poor outcome. Recent evidence demonstrates that the epithelial barrier can be supported by short chain fatty acids derived from microbiota fermentation of fermentable carbohydrate.4 We hypothesize that, if introduced early in the management of malnutrition, such fermentable carbohydrate based supplements, could safely and cheaply improve global outcome by improving mucosal integrity and enhancing immunity and thereby reducing diarrhoea, the risk of systemic infection and the overuse of broad-spectrum antibiotics hence reducing resistance. The major objectives: To provide proof of this principal we will conduct a pilot study to assess the effects of adding a source of non-digestible fermentable carbohydrate (either cowpea flour or inulin) to standard feeds in Ugandan children with severe acute malnutrition. We will assess the effects on intestinal permeability (dual sugar test), gut inflammation (faecal calprotectin), gut microbiome and clinical outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MIMBLE
Disease(s) or condition(s) being studied Malnutrition,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/01/2016
Actual trial start date 25/01/2016
Anticipated date of last follow up 26/04/2016
Actual Last follow-up date 26/05/2016
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 54
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used) Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group F75 and F100 Nutritional Milk feeds as per WHO protocol until transition to usual feeds Nutition 30 Active-Treatment of Control Group
Experimental Group B. Standard treatment WHO feeds (F75/F100) plus a non-digestible fermentable carbohydrate as inulin as per WHO feeding protocol until transition to usual feeds nutritional 30
Experimental Group Cereal-based recipe for WHO feeds (F75/F100) plus a non-digestible fermentable carbohydrate as cowpe as per WHO feeding protocol until transition to usual feeds nutritional 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Anthropometric features of severe acute malnutrition as per WHO Child Growth Standards (2006): 1. Marasmus: Mid-upper arm circumference (MUAC) <11.5cm or Weight-for-height Z-score (WHZ) < -3 2. Kwashiorkor: Symmetrical pitting oedema involving at least the feet irrespective of WHZ score or MUAC 3. Guardian or parent willing and able to provide consent Children with severe acute malnutrition with a very high risk of early death will be excluded: ¿ Impaired consciousness: one of prostration (inability to sit unsupported or inability to breast feed if < 9months) or coma (inability to localise a painful stimulus) after correction of hypoglycaemia if present. ¿ Shock: two or more of capillary refill time > 3s, lower limb temperature gradient or weak radial pulse volume. ¿ Severe dehydration: Sunken eyes and reduced skin turgor in the presence of diarrhoea (3 or more episodes of profuse and watery stool) ¿ Respiratory distress: increased work of breathing and hypoxia (oxygen saturation < 90% in air) Additionally children who cannot complete accurate dietary recall will be excluded: ¿ Exclusively breast-fed infants 6 Month(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/11/2015 Imperial College Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
5L10D, 5th Floor, Lab Block, Fulham Palace Road London W9 8RF United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/11/2015 Mbale Regional Referral Hospital REC
Ethics Committee Address
Street address City Postal code Country
Palisa Road Zone Mbale PO Box 921 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Co-primary outcome measures: 1.Weight gain (moderate to good: >5g/kg/day) 2. Survival to Day 28 Day 28
Secondary Outcome 1. Clinical outcome : a.Time to diarrhoea resolution (if >3 loose stools/day) b. Time to oedema resolution c. Time to return of appetite d. Time to nutritional rehabilitation Up to Day 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbale Regional Referral Hospital Pallisa Road Zone Mbale P.O Box 921 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Imperial College ISS Fellowship (Wellcome Trust) to Nuala Calder Wellcome Centre for Clinical Tropical Medicine London W2 1PG United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Imperial College London London United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Nuala DM Calder Wellcome Centre for Clinical Tropical Medicine London W2 1PG United Kingdom
Kathryn Maitland Wellcome Centre for Clinical Tropical Medicine London W2 1PG United Kingdom
Peter Olupot Olupot Pallisa Road Zone Mbale P.O Box 921 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kathryn Maitland k.maitland@imperial.ac.uk +442075942523 Wellcome Centre for Clinical Tropical Medicine
City Postal code Country Position/Affiliation
London W2 1PG United Kingdom Professor of Paediatric Infectious Disease
Role Name Email Phone Street address
Principal Investigator Nuala Calder nualacalder@doctors.org.uk +4420 7594 389 Wellcome Centre for Clinical Tropical Medicine
City Postal code Country Position/Affiliation
London W2 1PG United Kingdom ISSFellow
Role Name Email Phone Street address
Principal Investigator Peter Olupot Olupot polupotolupot@yahoo.com + 256 772457217 Pallisa Zone Road
City Postal code Country Position/Affiliation
Mbale P.O Box 921 Uganda Director Mbale Clinical Research Institute
Role Name Email Phone Street address
Public Enquiries JSO Obbo stephen.obbo@gmail.com +256772437407 Pallisa Zone Road
City Postal code Country Position/Affiliation
Mbale P.O Box 921 Uganda The Chairman MRRH-REC
Role Name Email Phone Street address
Scientific Enquiries Kathryn Maitland k.maitland@imperial.ac.uk +254733411022 St Mary's Campus Norfolk Place
City Postal code Country Position/Affiliation
London W2 1PG United Kingdom Professor of Paediatric Infectious Disease
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information