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.: PACTR202108842939734 Date of Approval: 19/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Probiotics in children with Severe Acute Malnutrition
Official scientific title Effect of Probiotics on morbidity in the community-based treatment of severe acute malnutrition: a randomized controlled study in Congolese children.
Brief summary describing the background and objectives of the trial Background: Severe acute malnutrition (SAM) is a major contributor to the overall burden of child morbidity and mortality. Worldwide, it affects more than 16 million children, and is the direct cause of 0.5 to 1 million child deaths annually. It is also an important underlying contributor to many other child deaths, especially those due to pneumonia and diarrhea. Those who survive frequently suffer from long-term sequelae including growth failure and neurodevelopmental impairment. Earlier studies have indicated that Bifidobacterium animalis subspecies lactis BB-12 and Lactobacillus rhamnosus Lactobacillus rhamnosus GG reduce diarrhea and acute respiratory infections in well-nourished children, and that Lactobacillus rhamnosus GG may reduce diarrhea in undernourished children. ProbiSAM study conducted in Uganda in 2016 in 400 malnourished children aged 6-59 months, using the same strains, has been inconclusive. The lack of efficacy of probiotics in this study could be explained by several factors: (i) children included in ProbiSAM study were often ill with multiple life-threatening conditions and it may have affected their ability to respond to probiotic treatment; (ii) Broad-spectrum antimicrobials administered to these children during inpatient care might have reduced gut colonization and hence efficacy of probiotic. Further studies addressing these barriers are needed to demonstrate the benefits, if any, of probiotics in malnourished children. Here, the investigators will assess, in a prospective trial, the benefits of probiotics as part of the case management of SAM in the outpatient setting. Objectives: To compare the morbidity and nutritional recovery rates of children with SAM treated at home with ready-to-use therapeutic food (RUTF) with and without probiotics as part of their outpatient case management.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PruSAM Study
Disease(s) or condition(s) being studied Digestive System,Haematological Disorders,Nutritional, Metabolic, Endocrine,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/08/2021
Actual trial start date 21/08/2021
Anticipated date of last follow up 31/08/2022
Actual Last follow-up date 31/08/2022
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo group 1 ml of study product contained coconut oil without probiotic strains 4 weeks. 1 ml of study product contained coconut oil will be administered orally, once a day. The first dose will be given at inclusion, at the health center. Then we will give the parent the the bottle of the remaining medication. At home, the placebo will be taken with a cold meal. 200 Placebo
Experimental Group probiotics group 1 ml of study product containing coconut oil with a combination of the 2 probiotic strains, Lactobacillus rhamnosus GG (LGG) and Lactobacillus reuteri (LR) (dosage 2 billion colony-forming units, 50:50). 4 weeks 1 ml of study product containing coconut oil with probiotics will be administered orally, once a day. The first dose will be given at inclusion, at the health center. Then we will give the parent the the bottle of the remaining medication. At home, the placebo will be taken with a cold meal. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged between 6-24 months; Residence in the study area; Uncomplicated SAM criteria: Children with WHZ/WLZ < -2 or MUAC < 115mm; or with edema + (defined as a mild edema on both feet/ankles) or ++ (moderate edema on feet and lower legs, hands or lower arms) without medical complications signs described above; Parental consent Children < 6 months or > 24 months; Children with edema +++ (severe edema generalized to feet, legs, hands, arms and face); Complicated SAM (signs described above) Children with chronic debilitating illnesses such as cerebral palsy, congenital heart disease, Down syndrome, cleft lip/palate; Children who have a history of allergies to RUTF; No parental consent Infant: 13 Month(s)-24 Month(s) 6 Month(s) 24 Month(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 08/05/2020 Comite Institutionnel d Ethique de la Sante CIES
Ethics Committee Address
Street address City Postal code Country
South Kivu Bukavu 00243 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of diarrhea biweekly throughout a period of minimum 8 weeks and maximum 12 weeks
Secondary Outcome Incidence of diarrhea biweekly throughout a period of minimum 8 weeks and maximum 12 weeks
Secondary Outcome Incidence of pneumonia biweekly throughout a period of minimum 8 weeks and maximum 12 weeks
Secondary Outcome Referrals At each visit
Secondary Outcome Nutritional recovery At each visit
Secondary Outcome weight gain (in g/kg/day) At each visit
Secondary Outcome Nonresponse At the end
Secondary Outcome Death At each visit
Secondary Outcome RUTFs and probiotics safety At each visit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Nutritionnel Saint Joseph Kadutu South Kivu 00243 Democratic Republic of the Congo
Centre Nutritionnel Tupendane Kadutu South Kivu 00243 Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Universit Catholique de Bukavu Avenue Mitchombero Bukavu Democratic Republic of the Congo
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UCLouvain Woluwe Saint Lambert Brussels 1200 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Dimitri Van der Linden Woluwe Saint Lambert Brussels 1200 Belgium
Laure Bindels Woluwe Saint Lambert Brussels 1200 Belgium
Isabelle Scheers Woluwe Saint Lambert Brussels 1200 Belgium
Esto Bahizire South Kivu Bukavu 00243 Democratic Republic of the Congo
Gaylord Amani Ngaboyeka South Kivu Bukavu 00243 Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Richard Mbusa Kambale richkambale7@gmail.com +243993801883 South Kivu
City Postal code Country Position/Affiliation
Bukavu 00243 Democratic Republic of the Congo PhD Student UCLouvain
Role Name Email Phone Street address
Public Enquiries Esto Bahizire esto.bahizire@gmail.com +243813148592 South Kivu
City Postal code Country Position/Affiliation
Bukavu 00243 Democratic Republic of the Congo Nutrition and Public Health Universit Catholique de Bukavu
Role Name Email Phone Street address
Scientific Enquiries Dimitri Van der Linden dimitri.vanderlinden@uclouvain.be +32478558043 Woluwe Saint Lambert
City Postal code Country Position/Affiliation
Brussels 1200 Belgium Pediatric Infectious Diseases Pediatric Department Cliniques universitaires Saint Luc
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Baseline patients’ characteristics ; Results of probiotic treatment on diarrhea, acure respiratory infections, nutritional recovery, and transfer rate in inpatient care; Probiotic and RUTF safety Study Protocol 2 years Opened
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information