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

NCT03864549 | Completed

• 1 other identifier: 0003-19
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 4

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. 1.The rate of women requiring medications for glycemic control
2. 2.Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (23)

• 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)

Study Arms (2)

probiotic femina II

EXPERIMENTAL

research group will receive the probiotic formula Femina II (2 capsules/day) until delivery.

Dietary Supplement: Femina II

Placebo

PLACEBO COMPARATOR

control group will receive a placebo (2 capsules/day) until delivery.

Other: Placebo

Interventions

Femina II DIETARY_SUPPLEMENT

2 capsules per day until delivery

probiotic femina II

Placebo OTHER

2 capsules per day until delivery

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women who were diagnosed with GDM from 13 to 32.6 gestational weeks
• years old and older
• Singleton pregnancy

You may not qualify if:

• Women with pre-gestational diabetes mellitus
• GDM diagnosed ≥ 33 gestational weeks
• Women using prophylactic antimicrobial treatment
• Immunocompromised women
• Multiple pregnancy

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (4)

Assuta-Ashdod medical center

Ashdod, Israel

Location

Rambam medical center

Haifa, Israel

Location

Wolfson medical center

Holon, Israel

Location

Poriya Medical center

Tiberias, Israel

Location

Related Publications (2)

• 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.

  PMID: 37956906 DERIVED

• 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.

  PMID: 32575163 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: March 6, 2019
• Study Start: January 8, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

IL (4)