Dysphagia Clinical Trial
Official title:
Madrid - Tolerance and Acceptability Study
NCT number | NCT03834896 |
Other study ID # | AY:ST2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2017 |
Est. completion date | January 1, 2018 |
Verified date | February 2019 |
Source | Aymes International Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Tolerance and Acceptability of a gum based thickener.
Status | Completed |
Enrollment | 15 |
Est. completion date | January 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | AYMES International Ltd. | Haywards Heath |
Lead Sponsor | Collaborator |
---|---|
Aymes International Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GI side effects when using AYMES MADRID | Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES MADRID as assessed by presence / absence of side effect compared to baseline period. | 9 Days | |
Secondary | Compliance with prescription of AYMES MADRID | Recording of amount of AYMES PARIS consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES MADRID | 9 | |
Secondary | Bowel habits of subjects when using AYMES MADRID - frequency | Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period. | 9 days | |
Secondary | Bowel habits of subjects when using AYMES MADRID - stool consistency | Recording of bowel habits whilst subjects consuming AYMES MADRID, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period | 9 days |
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