A multicentre evaluation of the post-gastrostomy management in patients with motor neurone disease

UK Chief Investigator

Professor Chris McDermott

Research summary

Motor neurone disease (MND) is a devastating terminal illness, causing a progressive weakness of muscles controlling movement, swallowing and breathing. Malnutrition and weight loss in patients with motor neurone disease (pwMND) are associated with increased disability and shortened survival, especially for those experiencing swallowing difficulties.

Long-term nutritional support for patients with severe swallowing problems can be achieved by placing a feeding tube, known as a PEG, RIG, PIG, g-tube or gastrostomy, directly into the stomach.

Evidence from our previous research suggested the optimal method, and timing for, gastrostomy insertion in pwMND; however, there is lack of evidence to indicate the optimal ways for the nutritional management of patients, following gastrostomy insertion. This may explain the worrying finding we (and other studies) identified; that the majority of patients continue to lose weight or make insignificant gains in weight, in the first three months following gastrostomy insertion.

The aim of this study is to understand the reasons behind the poor nutritional outcomes following gastrostomy in the majority of pwMND and provide evidence-based recommendations for the nutritional management of this patient group. We plan to observe a group of 200 patients who have undergone gastrostomy in 22 MND care centres and clinics in the UK. Each participant, depending on disease progression, will take part in the study for nine months following gastrostomy.

We will prospectively collect information about the different post-gastrostomy nutritional approaches and their effectiveness on the nutritional state of patients with motor neurone disease. We will measure the nutritional outcome for patients (in terms of weight percentage, body mass index and lean body mass variation at three, six and nine months following gastrostomy and identify factors that may influence this outcome.

Assessments will include measurements of weight, height, upper arm length and skin thickness, and the completion of a short questionnaire booklet.

Inclusion / exclusion criteria

Inclusion criteria

  1. Age >18 years.

  2. A diagnosis of amyotrophic lateral sclerosis (as defined by the El-Escorial criteria), primary muscular atrophy or progressive lateral sclerosis.

  3. A decision has been taken to refer the patient for a gastrostomy, regardless of indication.

  4. Participant is willing and able to give informed consent for participation in the study. If the participant is unable to provide written consent due to physical disability, an independent witness will be present at the informed consent discussion and sign the consent form on the participant's behalf.

Exclusion criteria

  1. Age <18 years.

  2. Patient declines gastrostomy.

  3. Contraindication to gastrostomy.

  4. Underlying significant co-morbidity (eg thyroid disease, cancer or other disease) that would affect survival or metabolic state, independent of MND.

  5. Patients who have undergone a successful gastrostomy (or are enterally fed via a nasogastric tube) before the start of the study.

  6. Significant decision-making incapacity preventing informed consent by the potential participant because of a major mental disorder, such as major depression, schizophrenia, or dementia.

Note: Other protocol defined inclusion/exclusion criteria may apply.

Current status

Closed to recruitment


  • Bristol

  • Cambridge

  • Derby

  • Dundee (Ninewells Hospital)

  • Edinburgh

  • Kingston-Upon-Thames

  • London (Royal Free Hospital)

  • London (St George's Hospital, Tooting)

  • London (St Thomas' Hospital)

  • Leicester

  • Liverpool

  • Middlesbrough

  • Newcastle

  • Oxford

  • Plymouth

  • Preston

  • Salford

  • Sheffield

  • Southampton

  • Stoke

Information about study sites

Contact details

Coordinating centre: Haris Stavroulakis

Telephone: +44 114 222 2267


Recruitment group(s)

Patients with MND

Recruitment target(s)

200 patients across the UK

Key dates

Study start date: 13 April 2017

Closure date: 31 October 2022


Sheffield Teaching Hospitals NHS Foundation Trust

Study design


Intervention (if applicable)

Not applicable

Phase (if applicable)

Not applicable

Outcome measures

Primary outcome measures: Change in weight percentage (%) at M3 following gastrostomy insertion.