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Gut bacteria booster tested for diabetes control

NCT ID NCT06448182

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a daily postbiotic capsule (a substance that helps good gut bacteria) could improve blood sugar control in adults with type 2 diabetes. 106 participants took either the postbiotic or a placebo for 12 weeks. Researchers also analyzed genetics and gut bacteria to see if personalized nutrition could be more effective. The goal was to manage diabetes, not cure it.

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

106 people

The number who actually took part.

Started

Jan 2025

Finished

Dec 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: * Men and women aged between 18 and 70 years. * Subjects diagnosed with DM2: glycosylated hemoglobin (HbA1c) ≥6.5% and/or basal glucose ≥126 mg/dL. Debut time will not be taken into account. * Body Mass Index (BMI) between 25 and 39.9 kg/m2. * Treatment for DM2/stable lifestyle, as well as other treatments for other pathologies (stable at least 3 months prior to the start of the intervention). * Stable baseline HbA1c or glucose value for at least 3 months before starting the intervention. * No weight variations (± 5%) during the last 3 months. * Subjects must be in general physical and psychological conditions that the researcher assesses in accordance with the objective of the study. * Subjects must be able to understand and be willing to sign the informed consent, and must comply with all study procedures and requirements. Exclusion Criteria: * Subjects who have received oral antibiotic treatment in the 45 days prior to the start of the study. * Patients who have started hypoglycemic treatment, especially in the 3 months prior to inclusion. Insulin treatment. * Severe untreated dyslipidemia, hypertension or hypothyroidism, or treated for less than 3 months. * Presence of relevant functional or structural anomalies of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory diseases or malabsorption. * Subjects who have undergone surgical interventions of the digestive system with permanent consequences (for example, gastroduodenostomy). * Suffer from any type of cancer or be undergoing treatment for it, or a period of less than 5 years since its eradication. * Subjects who work rotating shifts that include night shifts. * Presence of some type of psychological impediment such as depressive pathology, anxiety, untreated bipolar disorder. They will be able to participate if they have the disease but with stable treatment for at least 3 months prior to the start of the trial. * Have an allergy or intolerance to any food or food group that is likely to manifest during the study. * Be on a special diet during the 3 months prior to the start of the study, except for treatment for DM2, in this case, the lifestyle/diet will have to be stable in the 3 months prior to the start of the study. * Weight variations (± 5%) during the last 3 months. * Suffer from eating disorders or present restrictive behaviors in their diet. Score on the EAT-26 questionnaire equal to or greater than 20. * Subjects who have undergone surgical treatment for obesity. * Be pregnant or breastfeeding. * Present alcohol abuse (more than 14 units/day in women and 20 units/day in men) and/or drugs. * Show poor collaboration or have difficulties to follow the study procedures. * Take some type of nutritional supplementation that can affect blood glucose and/or the microbiota. If they take it, in order to be included in the study, they will have to stop the supplement, with a washout period of at least 14 days before starting the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • IIS Biobizkaia

    Barakaldo, Vizcaya, 48903, Spain

  • Nutrition Research Centre, University of Navarra

    Pamplona, Navarre, 31008, Spain

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