Probiotics (Lactobacillus Rhamnosus) in Reducing Glucose Intolerance During and After Pregnancy
Status:
Unknown status
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Introduction: The overall aim of the study is to assess the efficacy of Lactobacillus
Rhamnosus in reducing glucose intolerance during and after pregnancy. A second objective of
the study is to determine the feasibility, compliance and safety of Lactobacillus Rhamnosus
among this cohort. Within this goal is to determine whether the investigators can enroll
women at high risk for developing Gestational Diabetes Mellitus (GDM) and follow them out at
regular antenatal visits and 6-weeks post partum.
Women with GDM are, 7 times more at risk of developing type 2 diabetes compared with those
who had a normo- glycaemic pregnancy. The population attributable risk for type 2 diabetes
mellitus (DM) in women with GDM is high, and around 30 - 50% women with GDM converts into
type 2 (DM) which is associated with pre-mature morbidity, mortality and high economic
burden. It is evident that untreated GDM is associated with higher incidence of complications
during pregnancy and increases the risk of perinatal mortality and infant morbidity. The
prevalence of GDM in Pakistan is around 8%, comparatively higher than other South Asian
countries. Therefore, interventions that can improve glucose regulation during pregnancy are
highly important.
Probiotics, the live micro-organisms, have shown promising results in regulating glucose
metabolism among pregnant mice. The effect of Probiotics on glucose metabolism is
attributable to their immuno-regulatory properties. They elicit powerful anti-inflammatory
capabilities by inhibiting the NF-kB pathway, which mediates microbial activation of the
immune system. Further, they diminish both fermentation of polysaccharides and induction of
fasting-induced adipocyte factor gene transcription. The safety of Lactobacillus Rhamnosus
among pregnant women is already established in other diseases.
A placebo controlled trial from Finland on pregnant females randomized to receive either
dietary counseling and Probiotics (Lactobacillus Rhamnosus), concluded improved glucose
tolerance as compared to the placebo group [OR 0.31 (95% CI 0.12, 0.78)]. However, this study
could not determine the sole effects of probiotics in reducing glucose intolerance.
Nevertheless, no studies on the role of Lactobacillus Rhamnosus in regulating glucose
intolerance have been conducted in any other part of the world yet. Therefore, a pilot trial
to see the efficacy, compliance and feasibility of Lactobacillus Rhamnosus among pregnant
females is imperative. The objectives of the investigators study are:
- To assess the efficacy of Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units
(CFU)/day) in reducing glucose intolerance among pregnant women attending antenatal
clinic of Karachi-Pakistan.
- To assess the feasibility, compliance and safety of conducting a double blind, placebo
controlled randomized trial of Lactobacillus Rhamnosus by recruiting high risk women
during pregnancy attending antenatal clinics and following them up 6 weeks postpartum in
Karachi-Pakistan.
Methods: For the pilot trial, women will be recruited from antenatal hospital of the city,
during 12-14 weeks of gestation.
Study Design: The study will be double blind randomized, placebo controlled trial.
Randomization will be done by blocked method. The dose of 1010 Colony forming Units (CFU)
once daily till delivery will be given orally.
Study Endpoints and Ascertainment: Baseline information will be comprised of socioeconomic
status, parity, gravida, blood pressure and obstetric history etc. The study endpoint
comprises of efficacy, feasibility, compliance and safety and will be ascertained at monthly
follow-up, during week 24 - 28, and 6 weeks post partum. Efficacy will be ascertained by Oral
Glucose Tolerance Test (OGTT) performed at randomization and during 24-28 weeks of gestation.
Feasibility and compliance will be assessed through recruitment rate, drop-out rate, reasons
for drop-out, non-participation and empty drug sachet count.