CClinicalTrials.gg
Sign In
CompletedNCT00337402Updated Nov 22, 2006

Effects of Gastrostomy on Amyotrophic Lateral Sclerosis

An observational study in Amyotrophic Lateral Sclerosis, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-11-22.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Defined population
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
01

Study summary

Results about effects of symptomatic treatment on QoL appears conflicting in ALS patients. Moreover no clear effects of gastrotomy have be shown on survival. Prospective study on effect of tube feeding, QoL and survival is performed in 17 teaching hospitals in France (observational study)

Read the detailed description

Following data have been recorded each three months: QoL (MOS-SF 36 and ALSAQ), bodily mass index, testing and ALS-FRS scale, functional respiratory measures, impedance analysis, and the time for tube feeding procedure, the conditions of the acceptance and side-effects of gastrotomy

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Gastrostomy
  • Quality of life
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 380 is above the median of 109 across 217 observational studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients > 18 years-old
  • ALS certain or probable
  • vital capacity (respiratory) > 70 %
  • under riluzole

Exclusion criteria

Exclusion Criteria:

  • ALS in family
  • other conditions affected survival and QoL
  • cognitive impairment
05

Study design

Observational model
Defined population
Time perspective
Prospective
Enrollment
380 participants
06

Study locations

1 site
  • Clermont-Ferrand University Hospital
    Clermont-Ferrand, 63003, France
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00337402
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
University Hospital, Angers, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Limoges, Neurological department of Lyon University Hospital, University Hospital, Marseille, University Hospital, Montpellier, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Nice, University Hospital, Paris, University Hospital, Strasbourg, University Hospital, Toulouse, University Hospital, Tours
First posted
Jun 16, 2006
Start date
Jan 2002
Completion
Jun 2005
Last update
Nov 22, 2006

Study contacts

Pierre Clavelou
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Motor Neuron Disease→

Other studies from this sponsor

University Hospital, Clermont-Ferrand

Start the discussion