Trial | NCT03834896  Report issue

Official Title

Madrid - Tolerance and Acceptability Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
Tolerance and Acceptability of a gum based thickener.
To evaluate the tolerance and acceptability of AYMES MADRID, in patients that may require modified consistency fluids. Measuring GI tolerance, compliance, convenience and preference.

To obtain data to support an ACBS submissions for AYMES MADRID (to allow for prescription in the community at NHS expense).
Study Started
Nov 01
2017
Primary Completion
Jan 01
2018
Study Completion
Jan 01
2018
Last Update
Feb 08
2019

Other AYMES MADRID

AYMES MADRID is a gum-based commercial thickener, that can be utilised to modify fluid consistencies to Stage 1, 2 or 3 (as per the National Descriptors for Texture Modification) to enhance the safety of fluids in those with dysphagia.

Experimental Experimental

Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by Speech and Language Therapist and who are expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.

Criteria 

Inclusion Criteria:

Adult patients (≥18 years) who are able to communicate clearly.
Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by -Speech and Language Therapist.
Patients expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.
Informed consent obtained from patient or for those without capacity following consultation with carers.

Exclusion Criteria:

Patients with maize / corn allergy requiring a maize free diet
Patients with inherited metabolic conditions.
Patients requiring enteral tube feeding or parenteral nutrition.
Patients with medical or dietary contraindication to any feed ingredients
Patients with delayed oral phase of swallowing.
Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
Patients with dysphagia not requiring stage 1, 2 or 3 thickened fluids.
Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study (to prevent over burdening of participants and ensure a period of normalisation between study involvement)
No Results Posted