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

NCT ID: NCT01436448

Last Updated: 2011-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Probiotics Lactobacillus Rhamnosus

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

Group Type: EXPERIMENTAL

Probiotics Lactobacillus Rhamnosus

Intervention Type: DRUG

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

Placebo

Microcrystalline cellulose/d each, up till deliver

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Probiotics Lactobacillus Rhamnosus

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Bilal Ahmed

Senior Instructor Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bilal Ahmed, MSc

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Abdul Jabbar, MBBS, FRCP

Role: STUDY_CHAIR

Aga Khan University

Kashmira Nanji, MSc

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Ali Khowaja, FRCS

Role:

Aga Khan University

Sarah Saleem, MBBS, MSc

Role:

Aga Khan University

Rozina Sikandar, MBBS, FCPS

Role:

Aga Khan University

Locations

Aga Khan Hospital for Garden

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 33870484 (View on PubMed)

Other Identifiers

111012MED

Identifier Type: -

Identifier Source: org_study_id