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.: PACTR202110878804071 Date of Registration: 27/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Probiotic supplementation among pregnant women in the third trimester
Official scientific title A double--blind randomized control trial of a synbiotic vs. placebo among pregnant women to evaluate colonization of the gut microbiota of their infants with Lactobacillus plantarum (Probiotics pilot in Ghana).
Brief summary describing the background and objectives of the trial The area under demographic surveillance of the Kintampo Health Research Centre (KHRC) offers a prime study site to evaluate the efficacy of the probiotic L. plantarum benefiting early life development. In our proposed study area of the Kintampo North Municipality, there are over 2,776 live-births per year. KHRC in previous studies has demonstrated the capacity to register pregnancies, births and newborn health outcomes, to recognize signs of infections in babies, and encourage care-seeking behaviour of their mothers within their communities. These systems together with the culture of care-seeking among participants in the study area is suitable to recruit pregnant women at 5 to 6 months of pregnancy, administer probiotic supplementation, follow up on care for the pregnancy and monitor compliance to supplementation, collect data as prescribed by the study, follow the delivery and sample collection. The successful completion of the previous prevalence pilot at KHRC and other clinical trials emphasize that the study activities together with collection of microbial specimens (stool and breast milk) as proposed is entirely feasible to assess the establishment of colonization.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Neonatal Diseases,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2021
Actual trial start date
Anticipated date of last follow up 28/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Experimental Group 2 daily capsules of Probiotics Supplement (Synbiotic (Nutraflora and Maltrin M100 P-95 and L. plantarum (Lp)) 6 months 75 pregnant women in their third trimester will be randomized to receive Synbiotic (Nutraflora and Maltrin M100 P-95 and L. plantarum (Lp) up to two weeks post-partum. Monitoring of initial dose onsite but subsequent doses remotely. Weekly pill will be checked and resupplied. Data to be obtained: - estimated length of gestation (gestational age) - birth weight and height of baby Samples to be obtained: a) MOTHER: - vaginal swab around birth only (if possible), - stool sample around birth and at 1 week and 1 month, - breastmilk at 1 week and 1 month b) Baby: - stool at 1 week and 1 month 75
Control Group Control Group 2 capsules daily of maltodextrin for 6 months 6 months 25 pregnant women in their third trimester will be randomized to receive maltodextrin up to two weeks post-partum. Monitoring of initial dose onsite but subsequent doses remotely. Weekly pill will be checked and resupplied. Data to be obtained: - estimated length of gestation (gestational age) - birth weight and height of baby Samples to be obtained: a) MOTHER: - vaginal swab around birth only (if possible), - stool sample around birth and at 1 week and 1 month, - breastmilk at 1 week and 1 month b) Baby: - stool at 1 week and 1 month 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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 Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 49 Year(s) Female
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 02/09/2021 Kintampo Health Research Centre Institutional Ethics Committee
Ethics Committee Address
Street address City Postal code Country
College Close Kintampo Box 200 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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). Baseline, Events, and at 6 months
Secondary Outcome 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. Baseline, Events, and at 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kintampo Municipal Hospital College close Kintampo Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Kintampo Health Research Centre College close Kintampo Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kintampo Health Research Centre College close Kintampo Ghana Research Institution
COLLABORATORS
Name Street address City Postal code Country
Prof. Tobias Kollman 15 Hospital Avenue Pert Australia
Dr. Nelly Amenyogbe 15 Hospital Avenue Perth Australia
Prof. Pinaki Panigrahi 3800 Reservoir Rd Washington DC United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seyram Kaali kaali.seyram@kintampo-hrc.org 00233546381925 College close
City Postal code Country Position/Affiliation
Kintampo Ghana Clinical research fellow
Role Name Email Phone Street address
Public Enquiries John Amoah john.amoah@kintampo-hrc.org 00233208209847 College close
City Postal code Country Position/Affiliation
Kintampo Ghana Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Dennis Adu Gyasi dennis.adu-gyasi@kintampo-hrc.org 00244888366 College close
City Postal code Country Position/Affiliation
Kintampo Ghana Biomedical Scientist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Probiotic Supplementation study will make Individual participant data available. Shared data will include all individual participant data collected during the trial, after deidentification. Other documents that will be made available will be Study Protocol, Statistical Analysis Plan and Informed Consent Form. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediately following publication., No end data. Researchers who wishes to access the data. To achieve aims in the approved proposal. Data request should be directed to the Sponsor contact, kwakupoku.asante@kintampo-hrc.org. To gain access, data requestors will need to sign a data access agreement.
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