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Could probiotics be the missing ingredient for gestational diabetes?

NCT ID NCT07645001

Disease control Sponsor: Riphah International University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study will test whether adding a probiotic supplement to standard diabetes medications (metformin or insulin) improves blood sugar control and reduces inflammation in pregnant women with gestational diabetes. Two hundred women diagnosed between 18-26 weeks of pregnancy will be split into four groups: metformin alone, insulin alone, metformin plus probiotics, or insulin plus probiotics. The goal is to see if the probiotic combination leads to better outcomes for both mother and baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
multistrain probiotic (HI flora sachet) plus metformin or insulin
What this could lead to
If it works, this could point toward a simple, safe way to improve blood sugar control and reduce complications for mothers and babies with gestational diabetes.
What could go wrong
This is an early-stage trial with 200 participants, so results may not apply to all women. Probiotics may not provide additional benefit over standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women (18-45 years of age). * Diagnosed with GDM between 18-26 weeks of gestation. * Singleton pregnancy. (Multiple gestations carry inherently higher risks like preterm birth, growth restriction and neonatal morbidity, Inclusion may introduce confounding thus restricting singleton pregnancies ensures population homogeneity). Exclusion Criteria: * Pre-existing diabetes mellitus. * Pregnancy induced hypertension. * Chronic gastrointestinal, hepatic, or renal disease. * Use of antibiotics or probiotics within the previous 4 weeks. * Multiple pregnancy. * Pregnancy with known fetal anomalies.

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Conditions

The condition(s) this trial relates to.

gestational diabetes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Pakistan Railway Hospital

    RECRUITING

    Rawalpindi, Punjab Province, 46000, Pakistan

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