Nutritional DeficiencyPEG-ALSNCT03487536
Nutritional Prognostic Factors in ALS
An observational study of Nutritional Deficiency and Neuro-Degenerative Disease, run by University of Bari at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nutritional Deficiency, Neuro-Degenerative Disease, Gastrostomy
- What is being tested?
- Nutritional assessment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2006to 31 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study included 47 consecutive patients referring to the Neurological ALS Tertiary Centre, Department of Basic Medical Sciences, Neurosciences and Sense Organs, who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit, Department of Emergency and Organ Transplantation, of the same University Hospital. All patients fulfilled revised El Escorial criteria for probable or definite classical ALS.
Who may be able to join
- ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit
Who cannot join
- ALS patients without PEG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy
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.
Read the detailed description
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.
- Being tested
- Nutritional assessment
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional assessmentOther
BMI and cholesterol levels evaluation
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional assessment
Weight and height (combined to report BMI in kg/m^2)
Measured: at the time of PEG placement (one day)
biochemical nutritional assessment
cholesterol levels
Measured: only at the time of PEG placement (one day)
Secondary outcomes (1)
body composition assessment
Evaluation of fat mass and fat free mass
Measured: within 2 months from the PEG implantation (one day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start2 Jan 2006
- Primary completion30 Jun 2015
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Barone, University of Bari
- Investigators
- Michele Barone, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487536
- Sponsor's protocol ID
- Policlinic Hospital 2, Bari
- Acronym
- PEG-ALS
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2018
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the results have not yet been shared with all the authors
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy
- ClinicalTrials.gov ID
- NCT03487536
- Acronym / sponsor ID
- PEG-ALS / Policlinic Hospital 2, Bari
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 2 Jan 2006 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study included 47 consecutive patients referring to the Neurological ALS Tertiary Centre, Department of Basic Medical Sciences, Neurosciences and Sense Organs, who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit, Department of Emergency and Organ Transplantation, of the same University Hospital. All patients fulfilled revised El Escorial criteria for probable or definite classical ALS.
Key inclusion criteria (1 listed)
- ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit
Key exclusion criteria (1 listed)
- ALS patients without PEG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional assessmentBMI and cholesterol levels evaluation | Other | – |
Primary outcome
nutritional assessment
Time frame: at the time of PEG placement (one day)
Weight and height (combined to report BMI in kg/m^2)
biochemical nutritional assessment
Time frame: only at the time of PEG placement (one day)
cholesterol levels
1 secondary outcome
body composition assessment
Time frame: within 2 months from the PEG implantation (one day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: Undecided. the results have not yet been shared with all the authors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Barone principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Deficiency and Neuro-Degenerative Disease, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nutritional assessment (time frame: at the time of PEG placement (one day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018; AzTrials last refreshed its copy on 28 Oct 2026.