AzTrials
AzTrials

Gestational Diabetes MellitusNCT03864549

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

A study testing Femina II in people with Gestational Diabetes Mellitus, run by HaEmek Medical Center, Israel at 4 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gestational Diabetes Mellitus
What is being tested?
Femina II
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
4 sitesIsrael
Study dates
8 Jan 2020to 1 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

Israel4 sites

  • Assuta-Ashdod medical center

    Ashdod

  • Rambam medical center

    Haifa

  • Wolfson medical center

    Holon

  • Poriya Medical center

    Tiberias

Other trials in Israel

About this study

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

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.

Read more

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.
Being tested
Femina II, Placebo
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Femina IIDietary supplement

    2 capsules per day until delivery

  • PlaceboOther

    2 capsules per day until delivery

Study groups in NCT03864549
Study groupRoleWhat they receive
probiotic femina IIExperimentalresearch group will receive the probiotic formula Femina II (2 capsules/day) until delivery.
Receives: Dietary Supplement: Femina II
PlaceboPlacebo comparatorcontrol group will receive a placebo (2 capsules/day) until delivery.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of women who will require pharmacotherapy for glycemic control.

    Measured: During the length of pregnancy (up to 9 months)

  2. Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.

    Measured: 2 weeks

Secondary outcomes (23)

  1. The rate of women with controlled diabetes

    Measured: During the length of pregnancy (up to 9 months)

  2. Mean daily glucose charts

    Measured: During the length of pregnancy (up to 9 months)

  3. Mean daily pre-prandial glucose values

    Measured: During the length of pregnancy (up to 9 months)

  4. Mean daily post-prandial glucose values

    Measured: During the length of pregnancy (up to 9 months)

  5. Level of glycated molecules

    Measured: During the length of pregnancy (up to 9 months)

  6. 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

    Measured: During the length of pregnancy (up to 9 months)

  7. The rate of cesarean deliveries

    Measured: At delivery

  8. The rate of labor inductions

    Measured: At delivery

  9. The rate of birth weight≥4000 gr

    Measured: At delivery

  10. The rate of birth weight> 90th percentile

    Measured: At delivery

  11. The rate of admission to the neonatal intensive care unit

    Measured: Within a week from delivery

  12. Apgar score at 1 and 5 minutes from birth

    Measured: Within 1-5 minutes after delivery

  13. The rate of neonatal hypoglycemia

    Measured: Within 1-2 days after delivery

  14. The rate of neonatal hyperbilirubinemia

    Measured: Within a week from delivery

  15. The rate of neonatal polycythemia

    Measured: Within a week from delivery

  16. The rate of neonatal hypocalcemia

    Measured: Within a week from delivery

  17. The rate of neonatal hypomagnesemia

    Measured: Within a week from delivery

  18. Cord blood pH levels

    Measured: At delivery

  19. The rate of neonatal malformations and developmental disorders

    Measured: 1-2 days after delivery

  20. birth weight

    Measured: At delivery

  21. Head circumference

    Measured: 1-2 days after delivery

  22. Maternal adverse effects

    Measured: During the length of pregnancy (up to 9 months)

  23. Duration of time until pharmacotherapy for glycemic control is indicated

    Measured: During the length of pregnancy (up to 9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2019
  2. Study start8 Jan 2020
  3. Primary completion1 Jun 2021
  4. Study completion1 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03864549
Sponsor's protocol ID
0003-19
Status last verified
Aug 2021
First submitted
21 Jan 2019
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37956906

  • 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.

    PubMed 32575163

Questions about this trial

What is this clinical trial studying?

A study testing Femina II in people with Gestational Diabetes Mellitus, run by HaEmek Medical Center, Israel at 4 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of women who will require pharmacotherapy for glycemic control. (time frame: During the length of pregnancy (up to 9 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03864549, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in