Status:
COMPLETED
The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus
Lead Sponsor:
HaEmek Medical Center, Israel
Conditions:
Gestational Diabetes Mellitus
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle change...
Eligibility Criteria
Inclusion
- Pregnant women who were diagnosed with GDM from 13 to 32.6 gestational weeks
- 18 years old and older
- Singleton pregnancy
Exclusion
- Women with pre-gestational diabetes mellitus
- 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).
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT03864549
Start Date
January 8 2020
End Date
August 1 2021
Last Update
August 3 2021
Active Locations (4)
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1
Assuta-Ashdod medical center
Ashdod, Israel
2
Rambam medical center
Haifa, Israel
3
Wolfson medical center
Holon, Israel
4
Poriya Medical center
Tiberias, Israel