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.: PACTR202407592711971 Date of Approval: 17/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Origines et dynamique de la dysbiose orale associée à un dysfonctionnement de l'environnement entérique. Intervention préventive chez les nourrissons d'Afrique centrale.
Official scientific title Origins and dynamics of oral dysbiosis associated with enteric environmental dysfunction. Preventive intervention among Central African infants.
Brief summary describing the background and objectives of the trial One in four children in the world suffers from stunted growth, and the best therapeutic interventions currently available cannot correct more than a third of the stunted growth. In the Afribiota study, we showed that stunting was associated with small intestinal bacterial proliferation dominated by bacteria normally found in the oropharyngeal cavity normally reside in the oropharyngeal cavity, and are associated with inflammation of the and reduced lipid absorption. Oral hygiene intervention is emerging as a new preventive approach to combating stunted growth. Our first objective is to demonstrate, through a specifically designed interventional trial with 720 infants and their families in Bangui, that educating families about oral oral and nasopharyngeal hygiene will significantly prevent or reverse the stuned growth. Our second objective is to study the oral cavity as a microbiological platform whose qualitative and quantitative alterations may have an impact on the child's future health. This includes a detailed description and monitoring of the assembly and dynamics of the oral microbiota from birth, including the determinants of its ecological successions, such as maternal and infant hygiene, antibiotic use and nutrition (including breastfeeding). Our third objective is to create the conditions for the development of a national oral health education programme in CAR. Afribiota2 will therefore have a direct clinical benefit in terms of both oral health and the treatment of undernutrition in Africa. The planned oral health intervention will also enable us to assess the role of oral hygiene on other comorbidities, an area of great interest, as there are no available data on oral health in Africa. The overall aim of Afribiota-2 is to capitalize on the strong momentum created and considerable results achieved by Afribiota-1. The latter made it possible to establish a medical, scientific and socio-anthropological framework for deciphering the aetiology of stunted grow
Type of trial RCT
Acronym (If the trial has an acronym then please provide) AFRIBIOTA2
Disease(s) or condition(s) being studied Digestive System,Ear, Nose and Throat,Nutritional, Metabolic, Endocrine,Oral Health,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Interventional trial
Anticipated trial start date 28/02/2024
Actual trial start date 22/04/2024
Anticipated date of last follow up 28/02/2026
Actual Last follow-up date 30/06/2026
Anticipated target sample size (number of participants) 720
Actual target sample size (number of participants) 720
Recruitment status Recruiting
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional nutritional strategy 12 months Conventional nutritional strategy comprising a ready-to-use lipid-based therapeutic food in small quantities (LNS-SQ), advice on water, sanitation and hygiene (WASH), and improved infant and young child feeding (IYCF). 720 Active-Treatment of Control Group
Experimental Group Standard nutritional strategy plus oral hygiene kit 12 months In addition to the standard nutritional strategy, a kit consisting of toothbrushes and toothpaste will be given to all members of the household to promote oral health. 720
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Infant in good health,  living in Bangui,  whose mother received at least one dose of intermittent preventive treatment (IPTp) against malaria during pregnancy,  and has given free, written and informed consent for her participation and that of her child in the study.  Infant born with complications during delivery (fever, problems with the umbilical cord, abnormal heart rate problems with the umbilical cord, abnormal heart rhythm of the baby, early break signs of perinatal asphyxia, shoulder dystocia, excessive bleeding).  Congenital disease: Trisomy 21, orofacial clefts, exomphaly (omphalocele), gastroschisis, hypospadias, reduction defects of the upper and lower limbs and lower limbs, talipes equinovarus, congenital heart defects, oesophageal atresia, large intestinal atresia/stenosis, anorectal atresia/stenosis, renal hypoplasia, etc.  Planning to move during the following year. Project No. 2022-072 Afribiota 2 Version 4F 5F of 29 May 26 June 2023 2024 2022-072-protocole-V5F_2024-05-29_Modifs-apparentes2022-072-protocole-V4F_26-06-2023-réponse CES Page 28/65  Born to a mother with a known history of chronic systemic disease (HIV infection, HBV or HCV infection, diabetes, high blood pressure, asthma, rheumatic disease, Chron's disease or inflammatory bowel disease, cardiac or cardio cardiac or cardio-circulatory disorders, hypo- or hyperthyroidism or other hormonal other hormonal alterations, psychiatric disorders, etc.),  Born to a mother who smokes  Born to a mother with a history of complications during pregnancy (placenta previa, placental abruption, complications linked to amniotic fluid, haemorrhage, pre-eclampsia, etc.) haemorrhage, pre-eclampsia or eclampsia, gestational diabetes, severe malaria during pregnancy (cerebral malaria, severe anaemia, etc.). Infant: 0 Month(s)-12 Month(s) 0 Month(s) 12 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 12/10/2023 CES
Ethics Committee Address
Street address City Postal code Country
FACSS Bangui 00236 Central African Republic
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The results relating to each patient in the research will be given to the patients as soon as possible by the investigator if the parameters studied are altered and have an impact on the child's care. impact on the child's care. During the first year
Secondary Outcome Multivariate mixed models (multilevel model) will also be used to will also be used to assess secondary outcomes (length, weight, head circumference, stunting) throughout the follow-up period, with a random intercept at infant level, and adjusted for the necessary covariates (age, treatment or control group, etc.), as there will be many repeated measurements for each infant. Throughout the monitoring period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut Pasteur de Bangui IPB Bangui 00236 Central African Republic
FUNDING SOURCES
Name of source Street address City Postal code Country
IRD Marseille Marseille France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institut Pasteur de Bangui Pasteur Bangui 00236 Central African Republic Funding Agency
Secondary Sponsor IRD Marseille Marseille France Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Institut Pasteur de Bangui Pasteur Bangui 00236 Central African Republic
IRD Marseille Marseille France
Institut Pasteur de Paris Paris Paris France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moya Alvarez Violeta violeta.moyaalvarez@ird.fr +33637455609 Marseille
City Postal code Country Position/Affiliation
Marseille France Investigateur Principal
Role Name Email Phone Street address
Public Enquiries Yap BOUM II yap.boum2@pasteur-bangui.cf +23672059717 Pasteur
City Postal code Country Position/Affiliation
Bangui Central African Republic Directeur
Role Name Email Phone Street address
Scientific Enquiries Emmanuel NAKOUNE emmanuel.nakoune@pasteur-bangui.cf +23672107920 Pasteur
City Postal code Country Position/Affiliation
Bangui Central African Republic DS
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Apart from the measures taken to control and ensure the quality of the research, each patient's medical data will only be transmitted to the sponsor or any person duly authorised by the sponsor, and, where applicable, to the authorised health authorities, under conditions guaranteeing their confidentiality. The sponsor and the supervisory authorities may request direct access to the medical file in order to verify the clinical trial procedures and/or data, without breaching confidentiality and within the limits authorised by the laws and regulations. Study Protocol During the study and 2 years after the last publication of the results or until the final research report is signed. Study PI and Co-PI
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