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Could extra calories slow ALS? new trial tests feeding tube nutrition

NCT ID NCT06877143

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether giving ALS patients 20% more calories than their body needs (via a feeding tube) can slow the disease. Researchers will measure a nerve damage marker in the blood over 6 months. 76 adults with ALS who already use a feeding tube will be randomly assigned to get either their exact calorie needs or 20% extra.

What this could mean

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

Active substance
hypercaloric PEG nutrition (120% of calorie needs)
What this could lead to
If it works, this could point toward a simple dietary strategy to slow ALS progression and improve survival.
What could go wrong
This is a small, early-phase trial (76 people) and the benefit is uncertain. The intervention is only for patients already using a feeding tube, so results may not apply to all ALS patients.

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 76 people

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

Started

Mar 2025

Expected to finish

Sep 2031

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 years and older

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: * Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria 1 * Loss of ALS functional rating scale revised (ALSFRS-R) of ≥ 0.33 points per month since onset (first paresis) based on the formula: (48 - Score at Screening Visit) / (Months between Onset and Screening Visit) * Nutrition via PEG * Age ≥18 years * Intake of a stable dose of riluzole for at least 4 weeks, or no riluzole * Capable of thoroughly understanding all information given and giving full informed consent according to GCP Exclusion Criteria: * Previous participation in another interventional study within the preceding 4 weeks * Absence of adequate social support and cooperation, or personal motivation (in the judgment of the investigator) to complete the study satisfactorily * Pregnancy or breast-feeding females * Evidence of a major psychiatric disorder or clinically evident dementia

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

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

Amyotrophic lateral sclerosis (ALS)

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

  • Ulm Universita, Department of Neurology

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

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