Madrid - Tolerance and Acceptability Study

NCT03834896 | Completed

• 1 other identifier: AY:ST2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Tolerance and Acceptability of a gum based thickener.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Compliance with prescription of AYMES MADRID

  9

• Bowel habits of subjects when using AYMES MADRID - frequency

  9 days

• Bowel habits of subjects when using AYMES MADRID - stool consistency

  9 days

Study Arms (1)

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.

Other: AYMES MADRID

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aymes International Limited: lead

Study Sites (1)

AYMES International Ltd.

Haywards Heath, RH16 9PL, United Kingdom

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: November 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)