NCT07178067Completed
Longitudinal Evaluation of Short-Chain Fatty Acid Profiles During the Natural Disease Course and a Mediterranean Diet Intervention in Amyotrophic Lateral Sclerosis Patients
Short Chain Fatty Acids Profiles in Amyotrophic Lateral Sclerosis: Longitudinal Effects of Disease and Mediterranean Diet Intervention
Source: ClinicalTrials.gov · Last updated 17 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 44 (actual)
- First submitted
- 3 Sept 2025
- Start date
- 21 Jul 2022
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07178067
What you commit to
- Study type: Observational
- Participants enrolled: 44
- From 21 Jul 2022 to the primary completion date, 30 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent or ongoing treatment with antibiotics, probiotics, or prebiotics.
Other illness
- Presence of other neurodegenerative diseases.
- Major comorbidities, such as: heart failure, cancer, autoimmune diseases, systemic diseases.
- Gastrointestinal diseases that could influence gut microbiota.
Other
- Patients with an expected survival \<18 months.
- Low compliance with study procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Medicine, Pharmacy, Science and Technology of Târgu Mureș 'George Emil Palade' Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.