Probiotics (Lactobacillus Rhamnosus) in Reducing Glucose Intolerance During and After Pregnancy (GRIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Aga Khan University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Bilal Ahmed, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01436448
First received: September 7, 2011
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Glucose Intolerance
Pregnancy
Drug: Probiotics Lactobacillus Rhamnosus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Probiotics (Lactobacillus Rhamnosus) In Reducing Glucose Intolerance During and After Pregnancy: A Double Blind Randomized Controlled Trial in Antenatal Clinic of Karachi-Pakistan (GRIP)

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Glucose Intolerance [ Time Frame: 24-28 weeks of pregnancy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Feasibility [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics Lactobacillus Rhamnosus
dose of 1010 Colony forming Units (CFU) once daily till delivery will be given orally
Drug: Probiotics Lactobacillus Rhamnosus
Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units (CFU)/day)
No Intervention: Placebo
Microcrystalline cellulose/d each, up till deliver

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

High risk pregnancy ( presence of more than or equal to 1 of the following)

  • Maternal age greater than or equal to 35
  • Family history of diabetes among 1st degree relative defined as parents, siblings and children
  • Overweight (BMI greater than 23) Women visiting the antenatal clinics during 12-14 weeks of gestation Women with Singleton pregnancy Women whose delivery is planned at the study hospital

Exclusion Criteria:

  • History of GDM ( since in our setting the women are not usually screen for pre- gestational diabetes therefore it is difficult to differentiate between GDM and pre gestational diabetes)
  • Known Diabetes mellitus
  • Known chronic diseases ( hypothyroidism ,cardiac, renal, rheumatoid arthritis, carcinoma)
  • Women maintained on medications such as: corticosteroids, Azathioprin, antiepileptic epileptic drugs.
  • Known Poly Cystic Ovarian Syndrome
  • Non-residents of Karachi
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436448

Locations
Pakistan
Aga Khan Hospital for Garden Active, not recruiting
Karachi, Sind, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Bilal Ahmed, MSc Aga Khan University
Study Chair: Abdul Jabbar, MBBS, FRCP Aga Khan University
Principal Investigator: Kashmira Nanji, MSc Aga Khan University
Investigator: Ali Khowaja, FRCS Aga Khan University
Investigator: Sarah Saleem, MBBS, MSc Aga Khan University
Investigator: Rozina Sikandar, MBBS, FCPS Aga Khan University
  More Information

No publications provided

Responsible Party: Bilal Ahmed, Senior Instructor Research, Aga Khan University
ClinicalTrials.gov Identifier: NCT01436448     History of Changes
Other Study ID Numbers: 111012MED
Study First Received: September 7, 2011
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Aga Khan University:
efficacy
Lactobacillus Rhamnosus
glucose intolerance
feasibility
compliance and safety
reducing glucose intolerance during and after pregnancy

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 01, 2014