DysphagiaNCT03834896
Madrid - Tolerance and Acceptability Study
A study testing AYMES MADRID in people with Dysphagia, run by Aymes International Limited at 1 site in United Kingdom.
Trial summary
Tolerance and Acceptability of a gum based thickener. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- AYMES MADRID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Tolerance and Acceptability of a gum based thickener.
Read the 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 to support an ACBS submissions for AYMES MADRID (to allow for prescription in the community at NHS expense).
- Conditions
- Dysphagia
- Being tested
- AYMES MADRID
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYMES MADRIDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AYMES MADRID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 Days
Secondary outcomes (3)
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
Measured: 9
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.
Measured: 9 days
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
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Nov 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aymes International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834896
- Sponsor's protocol ID
- AY:ST2
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Madrid - Tolerance and Acceptability Study
- ClinicalTrials.gov ID
- NCT03834896
- Acronym / sponsor ID
- AY:ST2
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aymes International LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 to support an ACBS submissions for AYMES MADRID (to allow for prescription in the community at NHS expense).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: AYMES MADRIDPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AYMES MADRIDAYMES 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. | Other | Experimental |
Primary outcome
GI side effects when using AYMES MADRID
Time frame: 9 Days
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.
3 secondary outcomes
Compliance with prescription of AYMES MADRID
Time frame: 9
Bowel habits of subjects when using AYMES MADRID - frequency
Time frame: 9 days
Bowel habits of subjects when using AYMES MADRID - stool consistency
Time frame: 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYMES MADRID in people with Dysphagia, run by Aymes International Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI side effects when using AYMES MADRID (time frame: 9 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019; AzTrials last refreshed its copy on 27 Oct 2026.