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Could a mediterranean diet help ALS patients? new study explores gut health link

NCT ID NCT07178067

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study looked at 44 people with ALS and healthy controls to see how gut bacteria and short-chain fatty acids change over time. Researchers also tested whether a 6-month Mediterranean diet could shift these levels. The goal was to better understand the gut-brain connection in ALS, not to test a treatment.

What this could mean

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

Active substance
Mediterranean diet
What this could lead to
If successful, this could point toward dietary strategies to support gut health in ALS patients.
What could go wrong
This is a small, completed observational study, not a treatment trial. Results may not lead to direct clinical benefits.

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.

Participants

44 people

The number who actually took part.

Started

Jul 2022

Finished

Nov 2023

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.

Who is studied

This prospective, single-center study enrolled adults from Romania diagnosed with ALS at Neurology Clinic 1, Mureș County Clinical Emergency Hospital , with an ALS diagnosis within the past 12 months, disease duration under 1 year, El Escorial (1996) criteria-clinically probable or clinically definite ALS. ALS cohort: N=44 at baseline (T0, Aug-Oct 2022); mean age 58.4 ± 12.5 years; 28 men / 16 women. Follow-up: T1 (6 months): N=36 (8 deaths by T1). T2 (12 months): N=30 (6 additional deaths between T1 and T2). Healthy controls: N=40, age- and sex-matched community volunteers without known neurodegenerative or major systemic disease. The patients were recruited through consecutive recruitment at the Neurology Clinic 1, Mureș County Clinical Emergency Hospital (Târgu Mureș, Romania) over a 3-month window (01 Aug-31 Oct 2022).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 amyotrophic lateral sclerosis (ALS) in the past 12 months. * Disease duration of less than 1 year. * Fulfillment of the El Escorial diagnostic criteria (1996) for clinically probable or clinically definite ALS. Exclusion Criteria: * Patients with an expected survival \<18 months. * Presence of other neurodegenerative diseases. * Major comorbidities, such as: heart failure, cancer, autoimmune diseases, systemic diseases. * Gastrointestinal diseases that could influence gut microbiota. * Recent or ongoing treatment with antibiotics, probiotics, or prebiotics. * Low compliance with study procedures.

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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

  • University of Medicine, Pharmacy, Science and Technology of Târgu Mureș 'George Emil Palade'

    Târgu Mureş, Mureș County, 540142, Romania

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