Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS

NCT06609213 | Recruiting

• 2 other identifiers: 2024-464-NSU334957
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the proposed study is to evaluate if oral intake of EN formula preceding Gtube placement will impact tolerance upon placement and feeding via Gtube in pALS. This single arm intervention study all participants will receive the intervention and researchers will utilize validated indicators combined with clinical expertise to assess gastrointestinal symptoms of feeding intolerance before and after the intervention. The main questions this study aims to answer are:

1. 1.Wil participants meeting a greater percentage of their estimated nutritional needs at baseline present a slower disease progression rate and a lower incidence of GI symptoms of feeding intolerance when feeding via Gtube?
2. 2.Will there be significant change in feeding intolerance when oral intake of enteral nutrition formula precedes feeding via Gtube?
3. 3.Pre-Intervention: The lead in period of one-week preceding intervention phase I will be timed to initiate 3 weeks before the scheduled Gtube placement procedure. Patients will be advised to maintain their usual food and beverage intake. Dietary intake and GI symptoms data will be collected by research personnel.
4. 4.Phase I: Dietary intake data collected from the pre-intervention stage will be averaged and used to determine the number of cartons of enteral nutrition formula needed to meet the participants estimated nutritional needs. For two weeks +- 2 days participants will be directed to drink the number of cartons of a pre-selected enteral nutrition formula to meet their estimated nutritional needs when combined to their current oral dietary intake. A plant based EN formula (Kate Farms 1.4 Standard) commonly prescribed for pALS was selected to be provided to all patients in the study to keep this variable constant. Weekly data collection of dietary intake and GI symptoms will be ongoing.
5. 5.Phase II: At the end of phase I, patients will undergo a Gtube placement at their selected medical facility. For the following two weeks +- 2 days participants will be directed to feed via Gtube the same number of cartons of the enteral nutrition formula used orally on phase I and make no changes to their current oral intake.

Conditions

Amyotrophic Lateral Sclerosis; Gastrointestinal Intolerance; Enteral Nutrition Therapy

Keywords

amyotrophic lateral sclerosis; ALS; Gtube; enteral nutrition; feeding intolerance; EN intolerance; enteral nutrition intolerance; gastrointestinal symptoms; percutaneous endoscopic gastrostomy; PEG

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Symptoms

  Gastrointestinal symptoms of feeding intolerance will be monitored weekly using a clinician-administered survey in-person or via phone interview. The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item scale that combines each item into five symptom clusters including reflux, abdominal pain, indigestion, diarrhea, and constipation (Svedlund et al., 1988). Patients rate each item on a 7-point Likert scale (from no discomfort at all to very severe discomfort).

  5 weeks

Secondary Outcomes (1)

• Dietary Intake

  5 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

This is a single arm study in which all participants receive the intervention.

Other: Medical Food

Interventions

Medical Food OTHER

Enteral nutrition formula will be used both by mouth and via feeding tube. This product is considered a medical food.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of possible, probable, or definite ALS or motor neuron disease by the treating neurologist (El-Escorial Revisited).
• Planned tube feeding placement within the following 4 to 6 weeks.

You may not qualify if:

• History of Crohns disease, inflammatory bowel disease, irritable bowel syndrome, celiac disease, food allergies and/or sensitivities to any of the formula ingredients, neurodegenerative disease diagnosis outside of ALS, or other concomitant disorder that might contribute to GI symptoms.
• Diagnosis of frontotemporal dementia.
• Nil per oral status.
• Any reason causing the immediate need for a feeding tube placement, including but not limited to severe malnutrition diagnosis.

Sponsors & Collaborators

• Andrea Charvet: lead
• Nova Southeastern University: collaborator

Study Sites (1)

Nova Southeastern University, Cathy J, Husman ALS Center

Fort Lauderdale, Florida, 33314, United States

RECRUITING

Related Publications (7)

• Li J, Wang L, Zhang H, Zou T, Kang Y, He W, Xu Y, Yin W. Different definitions of feeding intolerance and their associations with outcomes of critically ill adults receiving enteral nutrition: a systematic review and meta-analysis. J Intensive Care. 2023 Jul 5;11(1):29. doi: 10.1186/s40560-023-00674-3.

  PMID: 37408020 BACKGROUND

• Marin B, Desport JC, Kajeu P, Jesus P, Nicolaud B, Nicol M, Preux PM, Couratier P. Alteration of nutritional status at diagnosis is a prognostic factor for survival of amyotrophic lateral sclerosis patients. J Neurol Neurosurg Psychiatry. 2011 Jun;82(6):628-34. doi: 10.1136/jnnp.2010.211474. Epub 2010 Nov 19.

  PMID: 21097551 BACKGROUND

• Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.

  PMID: 3123181 BACKGROUND

• Jenkins B, Calder PC, Marino LV. A systematic review of the definitions and prevalence of feeding intolerance in critically ill adults. Clin Nutr ESPEN. 2022 Jun;49:92-102. doi: 10.1016/j.clnesp.2022.04.014. Epub 2022 Apr 20.

  PMID: 35623881 BACKGROUND

• Gungabissoon U, Hacquoil K, Bains C, Irizarry M, Dukes G, Williamson R, Deane AM, Heyland DK. Prevalence, risk factors, clinical consequences, and treatment of enteral feed intolerance during critical illness. JPEN J Parenter Enteral Nutr. 2015 May;39(4):441-8. doi: 10.1177/0148607114526450. Epub 2014 Mar 17.

  PMID: 24637246 BACKGROUND

• Bond L, Ganguly P, Khamankar N, Mallet N, Bowen G, Green B, Mitchell CS. A Comprehensive Examination of Percutaneous Endoscopic Gastrostomy and Its Association with Amyotrophic Lateral Sclerosis Patient Outcomes. Brain Sci. 2019 Sep 4;9(9):223. doi: 10.3390/brainsci9090223.

  PMID: 31487846 BACKGROUND

• Blaser AR, Starkopf J, Kirsimagi U, Deane AM. Definition, prevalence, and outcome of feeding intolerance in intensive care: a systematic review and meta-analysis. Acta Anaesthesiol Scand. 2014 Sep;58(8):914-22. doi: 10.1111/aas.12302. Epub 2014 Mar 11.

  PMID: 24611520 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Andrea Charvet, PhD, RDN, LDN

CONTACT

954-262-6901; acharve1@nova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This single arm intervention study will utilize validated indicators combined with clinical expertise to assess GI symptoms of feeding intolerance before and after the intervention in a way that each patient serves as their own control.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)