Origines et dynamique de la dysbiose orale associée à un dysfonctionnement de l'environnement entérique. Intervention préventive chez les nourrissons d'Afrique centrale.

Not Applicable

Recruiting

• Conditions: Digestive System; Ear, Nose and Throat; Nutritional, Metabolic, Endocrine; Oral Health; Paediatrics

• Registration Number: PACTR202407592711971
• Lead Sponsor: Institut Pasteur de Bangui

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

? 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.

Exclusion Criteria

? 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.).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Multivariate mixed models (multilevel model) will also be used to <br>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.