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.: PACTR202102689928613 Date of Approval: 23/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title SENeGal SYNbiotic (SENGSYN) Study
Official scientific title Dietary supplementation with a synbiotic to improve growth in early life in Senegal: an individually randomised, 2 arm, open-label, controlled study of a synbiotic in infants in Kaffrine District, Senegal.
Brief summary describing the background and objectives of the trial Young children exposed to poor sanitation and hygiene develop a disorder of the gut called “environmental enteric dysfunction” (EED) characterised by abnormal histology, permeability defects, and inflammation. EED significantly impairs growth through reduced digestion and absorption of nutrients, increased susceptibility to infections and systemic inflammation that directly inhibits growth hormones. EED likely results from pathogenic microbes colonising the gut despite exclusive breastfeeding and improved hygiene. A healthy gut microbiome may provide colonisation resistance against enteropathogens. Probiotics are live beneficial bacteria such as bifidobacteria and lactobacilli and prebiotics are non-digestible compounds that encourage the growth of healthy gut bacteria. Synbiotics are prebiotics combined with probiotics. Dietary supplementation with a synbiotic may provide resilience to the developing gut microbiome against adverse environmental conditions that are associated with EED. As part of the GCRF Action Against Stunting Hub, we plan to evaluate whether administration of a synbiotic to infants up to age 6 months in Senegal improves linear growth through improved gut health. The synbiotic will contain a total of 5 billion live bacteria including two strains of bifidobacteria and one strain of lactobacilli. We will assess the effects of the intervention by measuring growth and also biomarkers of gut health, inflammation and growth in blood and stool samples collected during 1-18 months. We will also record episodes of illness with follow-up to 18 months. We will compare the infants in the intervention arm with controls recruited in an observation cohort who receive standard care but no dietary supplements.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SENGSYN
Disease(s) or condition(s) being studied Digestive System,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2021
Actual trial start date 25/10/2021
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 708
Actual target sample size (number of participants) 353
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
00000213 Senegal National Ethics Committee for Health Research
20 012 Liverpool School of Tropical Medicine Research Ethics Committee, Liverpool, UK
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Labinic synbiotic 5 billion CFU daily for first 10 days and weekly to age 6 months 0-5 months Labinic synbiotic: prebiotic (BENEO Orafti Synergy1; 50 oligofructose:50 FOS; 200mg) + 3 live bacteria: Lactobacillus acidophilus NCFM, Bifidobacterium infantis Bi-26 and Bifidobacterium bifidum Bb-06; total of 5 billion organisms/day 236
Control Group Routine care Not applicable Not applicable Routine care with no dietary supplement 472 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) singleton newborn 2) birth weight (BW) or current weight (if BW not known) 2000g or more 3) well infant who is breastfed and has taken at least one breastfeed well 4) age 1-3 days 5) informed consent secured from mother/carer 6) Infants of HIV positive women without known immunosuppression 1) multiple pregnancy (e.g. twin/triplets) 2) suspicion or presence of any acute illness (e.g. fever, receiving treatment with antibiotics) 3) congenital abnormality that might be life-threatening or impair growth 4) infant with potential contraindication to synbiotic (e.g. suspected immune suppression; cardiac abnormality) 5) mother unlikely to stay in study area for the duration of the study 6) any health staff or study staff concerns regarding safety to participate in the trial Infant: 0 Month-23 Month 1 Day(s) 3 Day(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 04/12/2023 Senegal National Ethics Committee for Health Research
Ethics Committee Address
Street address City Postal code Country
NA Dakar NA Senegal
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 07/09/2021 Liverpool School of Tropical Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Pembroke Place Liverpool L3 5QA 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 29/11/2023 London School of Hygiene and Tropical Medicine Observational and Interventions Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC1E 7HT United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Linear growth 12 months
Secondary Outcome Enteropathogens and biomarkers in stool 1. Enteropathogens: Salmonella, Shigella, E. coli, Vibrio, Yersinia, Aeromonas and Plesiomonas detected by analysis of faecal microbiome and bacterial culture with confirmation by serological and biochemical assays as appropriate; E. coli subtypes identified by multiplex PCR; ova, cysts and parasites by microscopy. 2. Stool biomarker of intestinal inflammation: Myeloperoxidase 3. Stool biomarker of increased intestinal permeability: α1-antitrypsin (AAT) 1, 6 and 18 months
Secondary Outcome Biomarkers in blood 4. Plasma marker of chronic inflammation: alpha-1-acid glycoprotein (AGP) 5. Plasma marker of acute inflammation: C-reactive protein (CRP) 6. Plasma marker of gut mucosal integrity: intestinal fatty acid binding protein (IFABP) 7. Plasma growth hormones: insulin-like growth factor (IGF)-1 and its carrier protein IGF binding protein 3 6 and 18 months
Secondary Outcome Clinical outcomes 8. Mortality 9. Weekly morbidity diary 10. Episodes of hospital admission 11. Episodes of sick-child clinic visits, e.g. diarrhoea; respiratory and skin infections 12. Anthropometric outcomes: weight, mid-upper arm circumference (MUAC), head circumference, skin folds, knee-heel length. Till age 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kaffrine district Not applicable Kaffrine region Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel Street London WC1E 7HT United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place Liverpool 111111 United Kingdom Research Institution
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Babacar Faye bfaye67@yahoo.fr +221338251998 5005 Dakar Fann
City Postal code Country Position/Affiliation
Dakar Senegal Head of the Department of Parasitology at Faculty of Medicine of Cheikh Anta Diop University
Role Name Email Phone Street address
Public Enquiries Benjamin Momo Kadia benjamin.kadia@lstmed.ac.uk +237694772820 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool 111111 United Kingdom Clinical Research Associate at Liverpool School of Tropical Medicine
Role Name Email Phone Street address
Scientific Enquiries Stephen Allen Stephen.Allen@lstmed.ac.uk +4401517053752 Pembroke Place
City Postal code Country Position/Affiliation
Liverpool L35QA United Kingdom Professor of Paediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Requests to access the fully-anonymised, raw data would be reviewed by the investigators based at LSTM and Senegal (or their representatives if appropriate). Approval to access the data will be granted only if the request is approved by all of the investigators. The LSTM Research Ethics Committees and Senegal National Ethics Committee for Health Research will be notified of any agreements to share data. Informed Consent Form,Statistical Analysis Plan,Study Protocol Following publication of main findings Approval by investigators in the UK and Senegal
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