Status:
COMPLETED
Longitudinal Evaluation of Short-Chain Fatty Acid Profiles During the Natural Disease Course and a Mediterranean Diet Intervention in Amyotrophic Lateral Sclerosis Patients
Lead Sponsor:
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Brief Summary
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 d...
Detailed Description
This study investigates the role of the microbiome-gut-brain axis in the progression of amyotrophic lateral sclerosis (ALS), with a focus on short-chain fatty acids (SCFAs) and their associated biomar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07178067
Start Date
July 21 2022
End Date
November 30 2023
Last Update
September 17 2025
Active Locations (1)
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1
University of Medicine, Pharmacy, Science and Technology of Târgu Mureș 'George Emil Palade'
Târgu Mureş, Mureș County, Romania, 540142