Can a gut supplement ease anxiety and depression in obesity?

NCT ID NCT06901739

Disease control Sponsor: Celia Bañuls Source: ClinicalTrials.gov ↗

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether a daily synbiotic supplement, which combines prebiotics and beneficial bacteria, can improve gut health and mental well-being in people with obesity. Researchers will give 120 adults with a BMI between 30 and 40 either the supplement or a placebo for 12 weeks, alongside dietary guidance. They will measure changes in gut bacteria, inflammation, appetite signals, and symptoms of anxiety and depression. The goal is to see if improving the gut microbiome can positively influence the gut-brain axis and support mental health in this population.

What this could mean

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

Active substance: A synbiotic supplement containing tannins and probiotic strains (Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium lactis), taken as one capsule daily for 12 weeks alongside dietary advice.
What this could lead to: If it works, this could point toward a simple dietary supplement that helps people with obesity manage both weight and mental health, such as easing symptoms of anxiety and depression.
What could go wrong: This is an early-stage trial with a modest size, so results may not be conclusive. The supplement might not meaningfully change gut bacteria or mood, and any benefits could be small or vary between individuals.

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 120 people

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

Started

Apr 2025

Expected to finish

Dec 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 65 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 with BMI 30-40kg/m2, with at least 5 years of diagnosed obesity evolution. * Patients have had stable body weight (\<5% of body weight changes) during the 3 months prior to the study. * Participants between 18 and 65 years of age. Exclusion Criteria: * All patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, Cushing's syndrome), or established liver and kidney failure (according to transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula \>60), previous bariatric surgery, and women during pregancy or lactation, will be excluded. * Participants who have been treated with antibiotics 3 months prior to inclusion. * Patients with different psychiatric disorders apart from anxiety and/or depression, and also those who are already on antidepressants before the inclusion.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder depressive disorder Inflammation Obesity obesity disorder psychiatric disorder

As listed by the trial registrant

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

Anxiety Depressive disorder Obese patients (bmi ≥ 30 KG/m²)

How to take part

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

The places running it

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

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

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A doctor treating you

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Can a gut supplement ease anxiety and depression in obesity?

What the study statuses mean