Status:
RECRUITING
Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis
Lead Sponsor:
University of Ulm
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Weight loss is a known negative prognostic factor in amyotrophic lateral sclerosis (ALS). Over the last years, various interventional studies targeting the energy deficit in ALS yielded promising resu...
Detailed Description
Patients eligible for study participation will be randomized to one of two groups (hypercaloric or isocaloric diet) at baseline visit. Intervention or control diet will be administered as an add-on to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06877143
Start Date
March 1 2025
End Date
March 1 2028
Last Update
March 14 2025
Active Locations (1)
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1
Ulm Universita, Department of Neurology
Ulm, Baden-Wurttemberg, Germany, 89081