NCT03679078

Brief 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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Aug 2018Dec 2027

Study Start

First participant enrolled

August 28, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 29, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

8.3 years

First QC Date

August 29, 2018

Last Update Submit

April 9, 2026

Conditions

DysphagiaMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal Tolerance

    Gastro-intestinal tolerance will be assessed daily throughout a 3 day baseline period before starting the study ONS and at the end of each week (day 10, day 17, day 24, day 31) using a standardised GI tolerance questionnaire including questions on number of bowel movements per day, other gastrointestinal symptoms such as flatulence, bloating, burping and abdominal discomfort. Patient-reported gastrointestinal symptoms with scale range for each symptom as s scale range minimum = none, maximum = severe. Change of symptom from baseline scale minimum = no change, maximum = worse.

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

Secondary Outcomes (5)

  • Compliance

    Once during baseline period (Day 1) and then daily through intervention period (Days 4-31)

  • Acceptability: Brief tick-box questionnaire

    Day 1, Day 17, Day 31

  • Anthropometry

    Day 1 and Day 31

  • Nutrient intake

    Day 1, Day 17 and Day 31

  • Safety (Adverse events reporting)

    31 days.

Study Arms (1)

IDDSI nutritional supplement drink

EXPERIMENTAL

Single arm designed, 28day on IDDSI nutritional supplement drink

Dietary Supplement: IDDSI nutritional supplement drink

Interventions

IDDSI nutritional supplement drinkDIETARY_SUPPLEMENT

ready-to-use nutritional supplement drink to be taken daily for 28 days

IDDSI nutritional supplement drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Aneurin Bevan University Health Board

Caerleon, NP16 3XQ, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Dudley Group NHS Trust

Dudley, United Kingdom

Location

Cwm Taf University Health Board

Llwynypia, United Kingdom

Location

Croydon Health NHS Trust

London, United Kingdom

Location

Lewisham and Greenwich NHS Foundation Trust

London, United Kingdom

Location

Great Western Hospitals NHS Foundation Trust

Swindon, United Kingdom

Location

Weston Area Health Trust

Weston-super-Mare, United Kingdom

Location

MeSH Terms

Conditions

Deglutition DisordersMalnutrition

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Rebecca Stratton, Dr

    Nutricia Ltd UK

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 20, 2018

Study Start

August 28, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

GB(8)