The effect of oral probiotics on glycemic control of women with gestational diabetes mellitus - multicenter, randomized, double blind, placebo controlled trial.

gestational diabetes mellitus glycemic control pregnancy pregnancy outcomes probiotics

Journal

American journal of obstetrics & gynecology MFM
ISSN: 2589-9333
Titre abrégé: Am J Obstet Gynecol MFM
Pays: United States
ID NLM: 101746609

Informations de publication

Date de publication:
11 Nov 2023
Historique:
received: 17 10 2023
revised: 29 10 2023
accepted: 08 11 2023
medline: 14 11 2023
pubmed: 14 11 2023
entrez: 13 11 2023
Statut: aheadofprint

Résumé

Gestational diabetes mellitus (GDM) should be treated adequately in order to avoid maternal hyperglycemia-related complications. Previously, probiotic supplements were suggested to improve fasting blood glucose in women with GDM. Yet, a major limitation of previous studies was that pre-prandial and especially post-prandial glucose values, which are important predictors of pregnancy outcomes, were not studied. To examine the effect of a mixture of probiotic strains on maternal glycemic parameters, particularly pre-prandial and postprandial glucose values and pregnancy outcomes among women with GDM. A multicenter prospective randomized, double blind, placebo controlled trial was conducted. Women newly diagnosed with GDM were randomly allocated into a research group, receiving two capsules of oral probiotic formula containing Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus (L) acidophilus, L. paracasei, L. rhamnosus and Streptococcus thermophilus (>6 × 10 Forty one and 44 women were analyzed in the treatment and placebo cohorts, respectively. Mean daily glucose during the first two weeks in the probiotics and placebo groups was 99.7±7.9 and 98.0±9.3 mg/dL, respectively; P=0.35. The rate of women needing pharmacotherapy due to poor glycemic control after two weeks of treatment in the probiotics and placebo groups was 24 (59%) and 18 (41%), respectively; P=0.10. Mean, pre-prandial and post-prandial glucose levels throughout the study period were similar between the groups (P>0.05). There were no differences in maternal and neonatal outcomes including birth weight and adverse effect profile between the groups. The oral probiotic product tested in this study did not affect glycemic control of women with GDM.

Sections du résumé

BACKGROUND BACKGROUND
Gestational diabetes mellitus (GDM) should be treated adequately in order to avoid maternal hyperglycemia-related complications. Previously, probiotic supplements were suggested to improve fasting blood glucose in women with GDM. Yet, a major limitation of previous studies was that pre-prandial and especially post-prandial glucose values, which are important predictors of pregnancy outcomes, were not studied.
OBJECTIVE OBJECTIVE
To examine the effect of a mixture of probiotic strains on maternal glycemic parameters, particularly pre-prandial and postprandial glucose values and pregnancy outcomes among women with GDM.
STUDY DESIGN METHODS
A multicenter prospective randomized, double blind, placebo controlled trial was conducted. Women newly diagnosed with GDM were randomly allocated into a research group, receiving two capsules of oral probiotic formula containing Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus (L) acidophilus, L. paracasei, L. rhamnosus and Streptococcus thermophilus (>6 × 10
RESULTS RESULTS
Forty one and 44 women were analyzed in the treatment and placebo cohorts, respectively. Mean daily glucose during the first two weeks in the probiotics and placebo groups was 99.7±7.9 and 98.0±9.3 mg/dL, respectively; P=0.35. The rate of women needing pharmacotherapy due to poor glycemic control after two weeks of treatment in the probiotics and placebo groups was 24 (59%) and 18 (41%), respectively; P=0.10. Mean, pre-prandial and post-prandial glucose levels throughout the study period were similar between the groups (P>0.05). There were no differences in maternal and neonatal outcomes including birth weight and adverse effect profile between the groups.
CONCLUSION CONCLUSIONS
The oral probiotic product tested in this study did not affect glycemic control of women with GDM.

Identifiants

pubmed: 37956906
pii: S2589-9333(23)00366-X
doi: 10.1016/j.ajogmf.2023.101224
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

101224

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Auteurs

Zohar Nachum (Z)

Department of Obstetrics & Gynecology, Emek Medical Center, Afula, Israel; Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.

Yuri Perlitz (Y)

Department of Obstetrics and Gynecology, Tzafon Medical Center, Poriya, Israel; Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.

Lilach Yacov Shavit (LY)

Diabetes in pregnancy clinic, Tzafon Medical Center, Poriya, Israel.

Galit Magril (G)

Nutrition division, Tzafon Medical Center Poriya, Israel.

Dana Vitner (D)

Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel; Department of Obstetrics & Gynecology, Rambam Health Care Campus, Haifa, Israel.

Yaniv Zipori (Y)

Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel; Department of Obstetrics & Gynecology, Rambam Health Care Campus, Haifa, Israel.

Eran Weiner (E)

Department of Obstetrics & Gynecology, Wolfson medical center, Holon, Israel; Sackler Faculty of Medicine, Tel Aviv university, Tel Aviv, Israel.

Ayala Shevach Alon (AS)

Department of Obstetrics & Gynecology, Wolfson medical center, Holon, Israel; Sackler Faculty of Medicine, Tel Aviv university, Tel Aviv, Israel.

Yael Ganor-Paz (Y)

Department of Obstetrics & Gynecology, Wolfson medical center, Holon, Israel; Sackler Faculty of Medicine, Tel Aviv university, Tel Aviv, Israel.

Meirav Nezer (M)

Department of Obstetrics and Gynecology, Samson Assuta Ashdod university Hospital, Ashdod, Israel.

Noa Harel (N)

Department of Obstetrics and Gynecology, Tzafon Medical Center, Poriya, Israel.

Sofia Soltsman (S)

Department of Obstetrics and Gynecology, Tzafon Medical Center, Poriya, Israel.

Enav Yefet (E)

Department of Obstetrics and Gynecology, Tzafon Medical Center, Poriya, Israel; Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel; Women's health center, Clalit health services, Afula, Israel. Electronic address: enavy1@gmail.com.

Classifications MeSH