Clinical Trial: Probiotics (Lactobacillus Rhamnosus) in Reducing Glucose Intolerance During and After Pregnancy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effects of Probiotics (Lactobacillus Rhamnosus) In Reducing Glucose Intolerance During and After Pregnancy: A Double Blind Randomized Controlled Trial in Antenatal Clinic

Brief 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.

  • Glucose Intolerance [ Time Frame: 24-28 weeks of pregnancy ]
    Glucose Intolerance. Glucose intolerance will be assessed in accordance with ADA guidelines by OGTT. OGTT will be performed during 24-28 weeks of pregnancy
  • Glucose Intolerance [ Time Frame: 6 to 8 weeks post partum ]
    Glucose Intolerance. Glucose intolerance will be assessed in accordance with ADA guidelines by OGTT. OGTT will be performed during 6 to 8 weeks post partum


    • Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Feasibility [ Time Frame: 36 weeks ]
      • Process of recruitment rate assessed at monthly antenatal visit
      • recruitment rate rate assessed at monthly antenatal visit
      • Reasons for non-participation rate assessed at monthly antenatal visit
    • Compliance [ Time Frame: 36 weeks ]
      • the compliance rate assessed at monthly antenatal visit
      • side effects rate assessed at monthly antenatal visit
      • drop-out rate rate assessed at monthly antenatal visit
      • reasons for drop-out rate assessed at monthly antenatal visit
    • Maternal safety [ Time Frame: at the time of delivery till 42 weeks postpartum ]

      MATERNAL OUTCOMES:( :( assessed at the time of delivery and postpartum)

      Maternal Mortality Maternal Weight Gain Preeclampsia Induction of labor Mode of Delivery

    • FETAL/NEONATAL safety [ Time Frame: assessed at the time of delivery till 6-8 weeks postpartum ]

      Death This will include:

      Still births Neonatal death Pre-term birth. Birth Trauma Macrosomia Small for Gestational Age Polyhydramnios Recurrent Hypoglycemia Large for Gestational Age Shoulder Dystocia 5-minute Apgar score: <7 Hyperbilrubinemia Respiratory Distress NICU Admission



    Original Secondary Outcome: Same as current

    Information By: Aga Khan University

    Dates:
    Date Received: September 7, 2011
    Date Started: October 2011
    Date Completion: May 2013
    Last Updated: September 19, 2011
    Last Verified: September 2011