The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

Official title:

The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus - Randomized, Double Blind, Placebo Controlled Trial, Phase 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864549
• Other study ID #: 0003-19
• Status: Completed
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: August 2021
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women who were diagnosed with GDM from 13 to 32.6 gestational weeks

• 18 years old and older

• Singleton pregnancy

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Dietary Supplement:
• Femina II
2 capsules per day until delivery

Other:
• Placebo
2 capsules per day until delivery

Locations

Country	Name	City	State
Israel	Assuta-Ashdod medical center	Ashdod
Israel	Wolfson medical center	H_olon
Israel	Rambam medical center	Haifa
Israel	Poriya Medical center	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of women who will require pharmacotherapy for glycemic control.		During the length of pregnancy (up to 9 months)
Primary	Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.		2 weeks
Secondary	The rate of women with controlled diabetes		During the length of pregnancy (up to 9 months)
Secondary	Mean daily glucose charts		During the length of pregnancy (up to 9 months)
Secondary	Mean daily pre-prandial glucose values		During the length of pregnancy (up to 9 months)
Secondary	Mean daily post-prandial glucose values		During the length of pregnancy (up to 9 months)
Secondary	Level of glycated molecules		During the length of pregnancy (up to 9 months)
Secondary	The rate of women with mean pre-prandial values = 95 mg/dl, mean post-prandial values = 130 mg/dl, and mean daily glucose > 100 mg/dl		During the length of pregnancy (up to 9 months)
Secondary	The rate of cesarean deliveries		At delivery
Secondary	The rate of labor inductions		At delivery
Secondary	The rate of birth weight=4000 gr		At delivery
Secondary	The rate of birth weight> 90th percentile		At delivery
Secondary	The rate of admission to the neonatal intensive care unit		Within a week from delivery
Secondary	Apgar score at 1 and 5 minutes from birth		Within 1-5 minutes after delivery
Secondary	The rate of neonatal hypoglycemia		Within 1-2 days after delivery
Secondary	The rate of neonatal hyperbilirubinemia		Within a week from delivery
Secondary	The rate of neonatal polycythemia		Within a week from delivery
Secondary	The rate of neonatal hypocalcemia		Within a week from delivery
Secondary	The rate of neonatal hypomagnesemia		Within a week from delivery
Secondary	Cord blood pH levels		At delivery
Secondary	The rate of neonatal malformations and developmental disorders		1-2 days after delivery
Secondary	birth weight		At delivery
Secondary	Head circumference		1-2 days after delivery
Secondary	Maternal adverse effects		During the length of pregnancy (up to 9 months)
Secondary	Duration of time until pharmacotherapy for glycemic control is indicated		During the length of pregnancy (up to 9 months)