High-calorie nutrition for ALS patients with PEG feeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of hypercaloric nutrition on patients with amyotrophic lateral sclerosis (ALS) who are fed via percutaneous endoscopic gastrostomy (PEG). Participants will be randomized into two groups receiving either a hypercaloric or isocaloric diet, with calorie requirements determined through indirect calorimetry. The study aims to assess whether a carbohydrate-rich, hypercaloric diet can stabilize body weight and improve survival in ALS patients. The intervention will be administered alongside standard therapy to evaluate its effectiveness in maintaining energy homeostasis.

Why it matters

Who can join: the full rules

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

Where it's running

• Ulm Universita, Department of Neurology
  Ulm, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Principal investigator: Christine Herrmann, Dr. — University of Ulm
• Study coordinator: Christine Herrmann, Dr.
• Email: christine.herrmann@uni-ulm.de
• Phone: 0049 731 177 5374

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.