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OpenTrials
Completed

NCT Number: NCT03834896

Madrid - Tolerance and Acceptability Study

Tolerance and Acceptability of a gum based thickener.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AYMES International Ltd.

Haywards Heath, RH16 9PL, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AYMES MADRID

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Compliance with prescription of AYMES MADRID

    Time frame: 9

    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

  2. Bowel habits of subjects when using AYMES MADRID - frequency

    Time frame: 9 days

    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.

  3. Bowel habits of subjects when using AYMES MADRID - stool consistency

    Time frame: 9 days

    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

Sponsors and collaborators

Lead sponsor

Aymes International Limited

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2019
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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