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.
NCT ID: NCT02705937
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
32 participants
INTERVENTIONAL
2017-09-13
2019-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Dairy product
The product will be taken for 14 days
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
Aequasyal mouth spray medical device
The spray will be taken for 14 days
Aequasyal mouth spray
The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days
Interventions
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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
Aequasyal mouth spray
The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days
Eligibility Criteria
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Inclusion Criteria
* Patients seen in the psychiatry department requiring the prescription of psychotropic drugs (antidepressants anxiolytics) for over 6 weeks
* Patients complaining of xerostomia
* Patients having not taken a palliative therapy against xerostomia for at least 2 weeks
* Patients having signed a free and informed consent form
* Patients affiliated to a social security system
Exclusion Criteria
* Patients suffering from Sjogren's syndrome
* Patients having been treated by radiation therapy for head or neck cancer
* Patients having stopped a palliative therapy against xerostomia for less than 2 weeks
* Patients under 18
* Pregnant or Breastfeeding women
* Incapacitated adults
* Patients placed under tutorship or curatorship
* Patients under judicial protection
* Patients suffering from milk allergy or lactose intolerance
18 Years
ALL
No
Sponsors
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Ecole Nationale de l'Industrie Laitière (ENIL)
UNKNOWN
Centre Hospitalier Universitaire Dijon
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Nazim NEKROUF, MD
Role: PRINCIPAL_INVESTIGATOR
Besancon University Hospital
Locations
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CHU de Besancon
Besançon, , France
Countries
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Central Contacts
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Facility Contacts
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Nazim NEKROUF, MD
Role: primary
Other Identifiers
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API/2015/65
Identifier Type: -
Identifier Source: org_study_id