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Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.

NCT02705937 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-10-06

No results posted yet for this study

Summary

Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva substitutes are disappointing (bad taste, poor efficiency).

The hypothesis stems from the "empirical" observations that many patients alleviate dry mouth symptoms by the consumption of dairy products. Through its composition, the dairy product in itself provides relief for the patient, due both to its physical and biochemical properties, which could explain these observed improvements, and to elements related to the phenomena of consumption of food as an alternative to medication. In the latter case, hedonism takes on a role which has not been previously assessed. Initial work undertaken with the department of applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new milk product, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia.

This dairy product has specific taste, texture and lubrication properties and will be tested in a randomized controlled cross-over study for its efficiency and acceptability versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at Dijon and at Besançon University Hospitals.

This way of combatting xerostomia at the interface of patients' diet, such as it is proposed here, could help improve their quality of life, minimize harmful effects (infection, decay) and promote adherence to treatments which are responsible for xerostomia.

Conditions

  • Xerostomia

Interventions

OTHER

Dairy product

Dairy products are given to patients with the instruction to eat as many products as necessary to provide them with some relief (within a limit of 6 per day) for 14 days

DEVICE

Aequasyal mouth spray

The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days

Sponsors & Collaborators

  • Ecole Nationale de l'Industrie Laitière (ENIL)

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire Dijon

    collaborator OTHER

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Nazim NEKROUF, MD · Besancon University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-13
Primary Completion
2018-03-31
Completion
2019-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02705937 on ClinicalTrials.gov