IDDSI Nutritional Drink for Dysphagia Study

Malnutrition Clinical Trial

Official title: An Evaluation of the Tolerance, Compliance, Acceptability and Safety of a New Oral Nutritional Supplement in Dysphagic Patients

Status Suspended

Clinical Trial 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.

Clinical Trial Description

Dysphagia is a complex condition common in a number of diagnoses including stroke, Parkinson's disease, head and neck cancer, dementia, learning disabilities and gastric/oesophageal motility disorders.

A modified textured diet and/or fluid is considered as an effective intervention in management of dysphagia. The International Dysphagia Diet Standardisation Initiative (IDDSI) have developed a new framework around the terms and descriptors used in the management of individuals with dysphagia. Malnutrition is very common in patients with dysphagia and the use of pre-thickened oral nutritional supplements (ONS) has been found as an effective way to manage this. However, due to impairment in the swallow process, dysphagic patients require pre-thickened oral nutritional supplement to ensure safe consumption of these nutritional supplements.

40 participants, requiring a new pre-thickened oral nutritional supplement in line with the new IDDSI framework recruited from hospitals, outpatients clinics, care homes, community hospitals, community dietetic/speech and language therapy services or stroke rehabilitation units will receive the ready-to-use oral nutritional supplement for a 4 week intervention period. This study aims to primarily evaluate gastro-intestinal tolerance, with secondary outcomes including compliance, acceptability, nutrient intake, anthropometry and safety. ;

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Malnutrition

• NCT number: NCT03679078
• Study type: Interventional
• Source: Nutricia UK Ltd
• Status: Suspended
• Phase: N/A
• Start date: August 28, 2018
• Completion date: December 1, 2024