The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus
NCT ID: NCT03864549
Last Updated: 2021-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2020-01-08
2021-08-01
Brief Summary
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Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated.
Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM.
Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects.
Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are:
1. The rate of women requiring medications for glycemic control
2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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probiotic femina II
research group will receive the probiotic formula Femina II (2 capsules/day) until delivery.
Femina II
2 capsules per day until delivery
Placebo
control group will receive a placebo (2 capsules/day) until delivery.
Placebo
2 capsules per day until delivery
Interventions
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Femina II
2 capsules per day until delivery
Placebo
2 capsules per day until delivery
Eligibility Criteria
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Inclusion Criteria
* 18 years old and older
* Singleton pregnancy
Exclusion Criteria
* GDM diagnosed ≥ 33 gestational weeks
* Women using prophylactic antimicrobial treatment
* Immunocompromised women
* Multiple pregnancy
* Women taking oral probiotic products who refuse to stop the consumption (food-containing probiotics is not considered an exclusion criterion).
18 Years
FEMALE
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Locations
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Assuta-Ashdod medical center
Ashdod, , Israel
Rambam medical center
Haifa, , Israel
Wolfson medical center
Holon, , Israel
Poriya Medical center
Tiberias, , Israel
Countries
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References
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Nachum Z, Perlitz Y, Shavit LY, Magril G, Vitner D, Zipori Y, Weiner E, Alon AS, Ganor-Paz Y, Nezer M, Harel N, Soltsman S, Yefet E. The effect of oral probiotics on glycemic control of women with gestational diabetes mellitus-a multicenter, randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101224. doi: 10.1016/j.ajogmf.2023.101224. Epub 2023 Nov 12.
Okesene-Gafa KA, Moore AE, Jordan V, McCowan L, Crowther CA. Probiotic treatment for women with gestational diabetes to improve maternal and infant health and well-being. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD012970. doi: 10.1002/14651858.CD012970.pub2.
Other Identifiers
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0003-19
Identifier Type: -
Identifier Source: org_study_id
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