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New thickened drink aims to help swallowing patients get nutrients safely

NCT ID NCT03679078

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new ready-to-use nutritional supplement drink designed for people with dysphagia (swallowing problems). Over 28 days, 40 adults who need at least 250 calories per day from a milkshake-style supplement will take the drink daily. Researchers will check how well patients tolerate it, how much they drink, and if they like it, using questionnaires about stomach symptoms and consumption.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nutritional supplement drink (IDDSI level 2, mildly thick)
What this could lead to
If successful, this could provide a well-tolerated and easy-to-use nutritional option for people with swallowing problems, helping prevent malnutrition.
What could go wrong
This is a small, early-stage study with only 40 participants, and it is currently suspended. The drink may cause gastrointestinal discomfort or not be well-accepted by all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female * Age ≥ 18 years * Patients with a requirement for ≥ 250kcal/day from a milkshake style ONS for ≥ 4 weeks or current users of ONS * Patients identified to require mildly thick (IDDSI level 2) fluids. * Patients competent to provide written informed consent and able to answer questions * Patients able to take study ONS orally Exclusion Criteria: * Patients that lack capacity to provide informed consent * Patients that are unable to take study ONS orally * Participants with chronic renal disease requiring dialysis * Participants with liver failure * Participants that are pregnant or lactating * Participation in other studies that may interfere with this study * Participants receiving 100% total nutritional requirements from tube feeding or parenteral nutrition * Patients with galactosaemia or lactose intolerance * Patients receiving palliative or end of life care

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders Malnutrition nutritional deficiency disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aneurin Bevan University Health Board

    Caerleon, NP16 3XQ, United Kingdom

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, United Kingdom

  • Croydon Health NHS Trust

    London, United Kingdom

  • Cwm Taf University Health Board

    Llwynypia, United Kingdom

  • Dudley Group NHS Trust

    Dudley, United Kingdom

  • Great Western Hospitals NHS Foundation Trust

    Swindon, United Kingdom

  • Lewisham and Greenwich NHS Foundation Trust

    London, United Kingdom

  • Weston Area Health Trust

    Weston-super-Mare, United Kingdom

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