High-calorie nutrition for ALS patients with PEG feeding
Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis
NA · University of Ulm · NCT06877143
This study is testing if a high-calorie diet can help ALS patients who are fed through a tube maintain their weight and live longer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ulm (other) |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Trial ID | NCT06877143 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of ALS who are receiving nutrition via PEG.
Not a fit: Patients who are not receiving PEG nutrition or those with major psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help stabilize weight and potentially improve survival rates in ALS patients receiving PEG nutrition.
How similar studies have performed: Previous studies have shown promising results with hypercaloric diets in ALS, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ulm, Baden-Wurttemberg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyotrophic Lateral Sclerosis, ALS, PEG, hypercaloric nutrition, energy deficit