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Gut health boost: synbiotics show promise for diabetes management

NCT ID NCT04552002

Disease control Sponsor: Imam Abdulrahman Bin Faisal University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether taking a synbiotic (a mix of probiotics and prebiotics) for 6 months could improve blood sugar control, reduce inflammation, and change body composition in adults with prediabetes or type 2 diabetes. Researchers recruited 64 participants from a hospital in Saudi Arabia and measured markers like HbA1c, inflammatory proteins, and body fat. The goal was to see if this simple dietary supplement could support diabetes management by targeting the gut microbiome.

What this could mean

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

Active substance
synbiotic (probiotics and prebiotics)
What this could lead to
If it works, this could point toward a simple dietary supplement to help manage blood sugar and inflammation in people with prediabetes or type 2 diabetes.
What could go wrong
This is a small, completed Phase 3 trial with only 64 participants, so results may not apply to everyone. Dietary supplements often show modest effects, and the study did not test long-term outcomes or safety beyond 6 months.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

64 people

The number who actually took part.

Started

Jan 2021

Finished

Apr 2025

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 70 years

Sex

Anyone

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: * Patients diagnosed with type 1 diabetes * Patients on insulin therapy * Patients on antibiotics * Pregnant and lactating women * Smoking individuals * Patients with comorbidities (except for hyperlipidemia and blood pressure) * Patients taking immunosuppressants * Patients taking probiotics, prebiotics or synbiotics Exclusion Criteria: * Patients with prediabetes (HbA1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl) * Patients with type 2 diabetes (HbA1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl * Male and female patients aged (18-70) years * Patients with HbA1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl * BMI ≥ 25

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Conditions

The condition(s) this trial relates to.

prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

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

Dietary supplements

Contacts and locations

Locations

  • Family Medicince Community Centre

    Dammam, Eastern Province, Saudi Arabia

  • King Fahd University Hospital

    Dammam, Eastern Province, Saudi Arabia

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