Evaluation of gastrointestinal tolerance of a new thickening powder in patients with dysphagia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26061

Enrollment

Registered

2006-01-04

Start date

2005-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia.

Interventions

After a 3-days run-in period with current thickening powder patients will receive thickening powder A or B for 14 days. Measurements of stool frequency & consistency, GI symptoms and food & fluid inta

Eligibility

Inclusion criteria

Inclusion criteria: Main criteria: 1. Oropharyngeal dysphagia confirmed by the SLT using bed-side swallowing evaluation or videofluoroscopy; 2. Neurogenic aetiology or caused by muscle weakness; 3. Stable severity (require thickend drinks for at least 3 weeks after inclusion); 4. Written informed consent.

Exclusion criteria

Exclusion criteria: Main criteria: 1. Impaired consciousness level; 2. Inadequate cognitive skills to comprehend study requirements and to communicate responses to questions; 3. Bowel habit unable to be defined using the study specific GI questionnaire; 4. Enteral tube feeding corresponding to > 50% of total energy intake; 5. Use of any foods or fluids thickened with another commercial thickener.

Design outcomes

Primary

Measure	Time frame
Gastrointestinal symptoms (measurements: Stool frequency & consistency, GI symptoms and food & fluid intake).	—

Secondary

Measure	Time frame
1. Patient product acceptibility (intake thickening powder); 2. Carer product evaluation (product evaluation questionnaire).	—

Contacts

Public ContactZandrie Hofman

Danone Research - Centre for Specialised Nutrition PO Box 7005

zandrie.hofman@danone.com+31 (0)317 467883

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)