Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05922683
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2023-06-20
Brief Title:
Maternal Probiotic Intervention to Improve Gut Health
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women a Proof of Concept Trial in Bangladesh Pakistan Senegal and Zambia
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MPIGH
Brief Summary:
There is an urgent need to identify interventions that can improve the supportive uterine environment in which the fetus establishes hisher growth Investigators believe that this necessitates improving the delivery of nutrients to the mother and in turn that requires a healthy microbiota Reducing intestinal inflammation will also have a profound impact on maternal and fetal immunity though there is limited information on the impact of maternal health on placental function This trial will determine if a well-established probiotic Vivomixx can modulate the maternal microbiota and ameliorate the maternal environmental enteropathy which compromises growth in the first 1000 days This trial is the first in a proposed series of proof-of-concept intervention studies that are intended to provide data to enable a rational selection of interventions to be evaluated at scale in future large-scale trials
This initial study will also serve the purpose of developing a harmonized multi-site Experimental Medicine Platform across four countries Bangladesh Pakistan Senegal Zambia Harmonized procedures will develop the capacity to deliver high-quality trials for the evaluation of potential interventions to improve maternal nutritional status and growth in utero To this end measuring and understanding variability in endpoint measurements is a key deliverable
This initial study will also serve the purpose of developing a harmonized multi-site Experimental Medicine Platform across four countries Bangladesh Pakistan Senegal Zambia Harmonized procedures will develop the capacity to deliver high-quality trials for the evaluation of potential interventions to improve maternal nutritional status and growth in utero To this end measuring and understanding variability in endpoint measurements is a key deliverable
Detailed Description:
76 healthy pregnant women in their second trimester will be enrolled and will be randomized to receive either probiotic or placebo for 8 weeks It will be a double-blind trial
Pregnant women will be recruited in the community through demographic surveillance system established in Matiari Pakistan The study staff will approach the potential participants and will introduce them to this study If Participants agree a screening consent form will be taken in which investigators will assess them clinically and will measure their hemoglobin level and gestational ultrasound for confirmation of their trimestergestational weeks Based on the screening results and clinical staff assessment women will be enrolled after taking trial participation consent
Once the participant is enrolled investigators will collect blood urine LR and stool samples flash frozen and CapScan before giving either a placebo or probioticwhich will be replenished after every 3 days investigators will then follow them weekly for compliance and adverse event data collection for 56 days 8 weeks investigators will again collect the same blood and stool samples after completion of 56 days An additional visit at 36 weeks will be done to record weight and for a gestational ultrasound Pregnancy outcomes will be recorded and then the child will be followed at 369 and 12 weeks for anthropometry and morbidity data collection Gestational ultrasounds will be performed at screening at 20 28 and 36 weeks of gestation
Pregnant women will be recruited in the community through demographic surveillance system established in Matiari Pakistan The study staff will approach the potential participants and will introduce them to this study If Participants agree a screening consent form will be taken in which investigators will assess them clinically and will measure their hemoglobin level and gestational ultrasound for confirmation of their trimestergestational weeks Based on the screening results and clinical staff assessment women will be enrolled after taking trial participation consent
Once the participant is enrolled investigators will collect blood urine LR and stool samples flash frozen and CapScan before giving either a placebo or probioticwhich will be replenished after every 3 days investigators will then follow them weekly for compliance and adverse event data collection for 56 days 8 weeks investigators will again collect the same blood and stool samples after completion of 56 days An additional visit at 36 weeks will be done to record weight and for a gestational ultrasound Pregnancy outcomes will be recorded and then the child will be followed at 369 and 12 weeks for anthropometry and morbidity data collection Gestational ultrasounds will be performed at screening at 20 28 and 36 weeks of gestation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None