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

NCT01436448 | Unknown Phase 3

• 1 other identifier: 111012MED
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Glucose Intolerance; Pregnancy

Keywords

efficacy; Lactobacillus Rhamnosus; glucose intolerance; feasibility; compliance and safety; reducing glucose intolerance during and after pregnancy

Outcome Measures

Primary Outcomes (2)

• Glucose Intolerance

  Glucose Intolerance. Glucose intolerance will be assessed in accordance with ADA guidelines by OGTT. OGTT will be performed during 24-28 weeks of pregnancy

  24-28 weeks of pregnancy

• Glucose Intolerance

  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

  6 to 8 weeks post partum

Secondary Outcomes (4)

• Feasibility

  36 weeks

• Compliance

  36 weeks

• Maternal safety

  at the time of delivery till 42 weeks postpartum

• FETAL/NEONATAL safety

  assessed at the time of delivery till 6-8 weeks postpartum

Study Arms (2)

Probiotics Lactobacillus Rhamnosus

EXPERIMENTAL

dose of 1010 Colony forming Units (CFU) once daily till delivery will be given orally

Drug: Probiotics Lactobacillus Rhamnosus

Placebo

NO INTERVENTION

Microcrystalline cellulose/d each, up till deliver

Interventions

Probiotics Lactobacillus Rhamnosus DRUG

Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units (CFU)/day)

Probiotics Lactobacillus Rhamnosus

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan Hospital for Garden

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• Davidson SJ, Barrett HL, Price SA, Callaway LK, Dekker Nitert M. Probiotics for preventing gestational diabetes. Cochrane Database Syst Rev. 2021 Apr 19;4(4):CD009951. doi: 10.1002/14651858.CD009951.pub3.

  PMID: 33870484 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Patient Compliance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bilal Ahmed, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Abdul Jabbar, MBBS, FRCP

  Aga Khan University

  STUDY CHAIR

• Kashmira Nanji, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Ali Khowaja, FRCS

  Aga Khan University

• Sarah Saleem, MBBS, MSc

  Aga Khan University

• Rozina Sikandar, MBBS, FCPS

  Aga Khan University

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Instructor Research

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 19, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

PA (1)