Status:
COMPLETED
Madrid - Tolerance and Acceptability Study
Lead Sponsor:
Aymes International Limited
Conditions:
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tolerance and Acceptability of a gum based thickener.
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03834896
Start Date
November 1 2017
End Date
January 1 2018
Last Update
February 8 2019
Active Locations (1)
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1
AYMES International Ltd.
Haywards Heath, United Kingdom, RH16 9PL