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NCT07178067: IMPACT-ALS

Longitudinal Evaluation of Short-Chain Fatty Acid Profiles During the Natural Disease Course and a Mediterranean Diet Intervention in Amyotrophic Lateral Sclerosis Patients

Completed Last updated 17 September 2025
What this trial tests

trial testing Mediterranean diet in Amyotrophic Lateral Sclerosis in 44 participants. Completed in 30 November 2023.

Timeline
21 July 2022
Primary endpoint
30 November 2023
30 November 2023

Quick facts

Lead sponsorGeorge Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
StatusCompleted
Study typeOBSERVATIONAL
Enrollment44
Start date21 July 2022
Primary completion30 November 2023
Estimated completion30 November 2023
Sites1 location across Romania

Drugs / interventions tested

Conditions studied

Sponsor

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

Who can join

18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This observational study explored the connection between the gut microbiota and the brain in patients with amyotrophic lateral sclerosis (ALS), specifically the modulation of short-chain fatty acids during disease progression and after following a Mediterranean diet for 6 months. Recent research suggests that the gut microbiome-the community of bacteria and other microorganisms living in our intestines-may influence how ALS develops and progresses. The hypothesis was that changes in the gut microbiome and the substances it produces, such as short-chain fatty acids (SCFAs), may play an important role in ALS progression. Additionally, the effect of the Mediterranean diet on circulating short-chain fatty acid concentrations was assessed.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Short-Chain Fatty Acid Profiles in Amyotrophic Lateral Sclerosis: Longitudinal Effects of Disease and Mediterranean Diet Intervention.
    Moțățăianu A, Ion V, Dumitreasă M, Ormenișan I, et al · · 2025 · cited 1× · PMID 41154611 · DOI 10.3390/biom15101380
  2. The gut microbiota influences neurodegenerative diseases through the gut-brain axis: molecular mechanisms and effects on immune function.
    Yang J, Song X, Yan S, Li Q, et al · · 2025 · PMID 41601624 · DOI 10.3389/fimmu.2025.1739329

Verify or expand the search:

Other trials of Mediterranean diet

Trials testing the same drug.

Other recruiting trials for Amyotrophic Lateral Sclerosis

Currently open trials in the same condition.

Other George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing