SuspendedNot Applicable

IDDSI Nutritional Drink for Dysphagia Study

Stopped: Project suspended whilst intervention is updated

United Kingdom40 participantsStarted 2018-08-28

Plain-language summary

This study will evaluate the gastrointestinal (GI) tolerance, compliance , acceptability and safety of a ready-to-use oral nutritional supplement drink for patients with dysphagia.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastrointestinal Tolerance

Timeframe: Day 1, Day 2, Day 3, Day 10, Day 17, Day 24 and Day 31

Trial details

NCT IDNCT03679078

SponsorNutricia UK Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-01

View on ClinicalTrials.gov More Dysphagia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.