Neonatal Diseases Pregnancy and Childbirth
Conditions
Interventions
Experimental Group
Control Group
Sponsors
Kintampo Health Research Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Gestational age 5 to 6 months (20 to 24 weeks) Pregnancy documented at ANC Willing to deliver in the study area and remain in the study area for the duration of the study Consent to be part of the study Willing to adhere to the study protocol requirements including supplementation with the study supplement or placebo.
Exclusion criteria
Exclusion criteria: Women who do not provide written informed consent Women whose pregnancies are not documented at an ANC. Women who are not living within the study area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate early establishment of probiotic strain in the gut flora of infants one-month post-partum, born to mothers who took probiotic supplement. 2. To estimate the level of compliance in the administration of a probiotic supplement among pregnant women. 3. To describe birth outcomes among participants who receive probiotic strains compared to those on placebo. 4. To identify relationships between maternal and newborn gut microbiomes related to infant health or infection. 5. To characterize the diversity of vaginal microbiomes among pregnant women in the study area. 6. Capture relevant birth clinical data (e.g. length of labour; duration of rupture of membranes; prenatal antibiotics). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Identify relationships between maternal and child microbiomes and newborn illness, and prevalence of bacteria among healthy mother-infant pairs 2. Characterize maternal factors (pregnancy, post-partum time, and diet) on their stool and breastmilk microbial communities. | — |
Countries
Ghana
Contacts
Public ContactJohn Amoah
Research Fellow
Outcome results
None listed