MedDataX Logo

Nutritional Prognostic Factors in ALS

NCT ID: NCT03487536

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-02

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background. Several nutritional factors have been evaluated as prognostic factors for survival in ALS patients at earlier stages of the disease \[body mass index (BMI), body composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels\], while only two studies have evaluated some of these parameters after PEG placement.

Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body composition and BMI in a subgroup of ALS patients was evaluated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis

NCT06877143

Amyotrophic Lateral Sclerosis (ALS)
RECRUITING NA

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

NCT06609213

Amyotrophic Lateral Sclerosis Gastrointestinal Intolerance Enteral Nutrition Therapy
RECRUITING NA

Feeding the Patient at Nutritional Risk: Does the Clinical Outcome Improve?

NCT00440453

Malnutrition
COMPLETED PHASE4

Malnutrition in Gastroenterology Patients

NCT00168935

Malnutrition
COMPLETED PHASE4

No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices

NCT02314130

Malnutrition
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Methods. Nutritional and neurological parameters were assessed at the time of PEG placement (T0) in 47 consecutive patients. Body composition and PhA were measured in only 22 patients within 2 months from T0. Survival was calculated as the time from the PEG placement to tracheostomy or death.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nutritional Deficiency Neuro-Degenerative Disease Gastrostomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nutritional assessment

BMI and cholesterol levels evaluation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit

Exclusion Criteria

* ALS patients without PEG
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Bari

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michele Barone

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michele Barone

Role: PRINCIPAL_INVESTIGATOR

University of Bari

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Policlinic Hospital

Bari, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Policlinic Hospital 2, Bari

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
NCT02117609 COMPLETED PHASE2
Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying
NCT02587611 COMPLETED NA
Comparison of Outcomes Between Parenteral and Enteral Nutrition
NCT02512224 COMPLETED
Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects
NCT00455247 COMPLETED PHASE3
Usability of myfood24 in Clinical Populations
NCT04758559 COMPLETED EARLY_PHASE1
Staircase Nutritional Intervention for Elderly Patients Undergoing Spinal Fusion Surgery
NCT07056647 NOT_YET_RECRUITING NA
The Effects of Perioperative Nutritional Optimization on Blood Markers
NCT04464161 COMPLETED NA
Oral (Hypo-)Function, General Function and Nutritional Status in Elderly Hospitalized Patients
NCT06557226 COMPLETED
Nutritional Therapy in Patients With Post-extubation Dysphagia
NCT06511284 RECRUITING NA
Nutritional Status and Pharmacological Treatment: Impact on the Toxicity and Quality of Life of Patients With Colorectal and Breast Cancer
NCT03759548 UNKNOWN
Basic Care Revisited: Early Nutrition Intervention for Outpatients
NCT02440165 UNKNOWN NA
Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery
NCT05373836 NOT_YET_RECRUITING
Impaired Preoperative Nutritional Status as a Risk Factor for Postoperative Clinical Outcome
NCT01492946 COMPLETED
Enteral Nutrition in Infants With Ileostomy
NCT04707443 RECRUITING
Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction
NCT06510348 RECRUITING NA
Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery
NCT03585413 COMPLETED PHASE3
Investigating Nutrition and Functional Outcome in Critically Ill Patients
NCT04180852 COMPLETED
Bolus Pouch Feed Study
NCT05822557 COMPLETED NA
Studies on the Impact of Taste-aware Intelligent Analysis of Oral Nutritional Supplements
NCT05651321 UNKNOWN
Nutritional Effect of an Amino Acid Mixture on Lean Body Mass (LBM) in Post-bariatric Surgery Patients
NCT00473356 COMPLETED NA
Effect of Oral Nutritional Supplements With Specialized Nutrients on Functional Recovery and Morbidity After Gastrointestinal Surgery
NCT00546975 TERMINATED NA
Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury
NCT05854264 UNKNOWN NA
Enteral Versus Parenteral Nutrition in the Conservative Treatment of Upper Gastrointestinal Fistula After Surgery
NCT03742752 TERMINATED NA
Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery
NCT06435416 COMPLETED
Non-inferiority Study of the Pursuit of Enteral Nutrition Compared to a Strategy of Gastric Emptiness Peri-extubation. Cluster Randomized Trial
NCT03335345 COMPLETED NA