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

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: Placebo; Dietary Supplement: Femina II

• Registration Number: NCT03864549
• Lead Sponsor: HaEmek Medical Center, Israel

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Study Start: 2020-01-08
• Primary Completion: 2021-06-01
• Status Verified: 2021-08
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	control group will receive a placebo (2 capsules/day) until delivery.
probiotic femina II	Femina II	research group will receive the probiotic formula Femina II (2 capsules/day) until delivery.

Primary Outcome Measures

Name	Time	Method
The rate of women who will require pharmacotherapy for glycemic control.	During the length of pregnancy (up to 9 months)
Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.	2 weeks

Secondary Outcome Measures

Name	Time	Method
Maternal adverse effects	During the length of pregnancy (up to 9 months)
The rate of admission to the neonatal intensive care unit	Within a week from delivery
Apgar score at 1 and 5 minutes from birth	Within 1-5 minutes after delivery
The rate of neonatal hypoglycemia	Within 1-2 days after delivery
Head circumference	1-2 days after delivery
The rate of labor inductions	At delivery
The rate of birth weight≥4000 gr	At delivery
The rate of birth weight> 90th percentile	At delivery
Duration of time until pharmacotherapy for glycemic control is indicated	During the length of pregnancy (up to 9 months)
The rate of neonatal hyperbilirubinemia	Within a week from delivery
The rate of neonatal polycythemia	Within a week from delivery
The rate of neonatal hypocalcemia	Within a week from delivery
The rate of neonatal hypomagnesemia	Within a week from delivery
Cord blood pH levels	At delivery
The rate of neonatal malformations and developmental disorders	1-2 days after delivery
birth weight	At delivery
The rate of women with controlled diabetes	During the length of pregnancy (up to 9 months)
Mean daily glucose charts	During the length of pregnancy (up to 9 months)
Mean daily pre-prandial glucose values	During the length of pregnancy (up to 9 months)
Mean daily post-prandial glucose values	During the length of pregnancy (up to 9 months)
Level of glycated molecules	During the length of pregnancy (up to 9 months)
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)
The rate of cesarean deliveries	At delivery

Trial Locations

Locations (4)

Rambam medical center; 🇮🇱 Haifa, Israel

Wolfson medical center; 🇮🇱 H̱olon, Israel

Assuta-Ashdod medical center; 🇮🇱 Ashdod, Israel

Poriya Medical center; 🇮🇱 Tiberias, Israel