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Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis

RecruitingNAAges 18 Years - anyAllUniversity of Ulm
NCT06877143 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 results; however,it is still unclear which kind of nutrition or nutritional supplement is most beneficial. Moreover, there is lack of evidence regarding interventions in patients with a PEG in later disease stages.In a pilot study conducted in 2013, it was demonstrated that body weight can be stabilized in ALS by applying either a fat-rich or carbohydrate-rich high-caloric food supplement. In 2014, Wills et al. conducted a placebo-controlled randomized controlled pilot study, which indicated that a carbohydrate-rich, hypercaloric diet, consisting in 125% of estimated energy requirements as determined by indirect calorimetry, in patients fed via percutaneous endoscopic gastrostomy was safe and we

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📋 Eligibility rules (as published)
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
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What it tests

  • 100% of individual calory requirement
  • 120% of individual calory requirement
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Where

1 site
Ulm Universita, Department of Neurology
Ulm, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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