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.

Study Overview
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Brief Summary
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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.

Official Title
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Early Phase Study Comparing the Effectiveness of a Dairy Product, Co-developed by Besancon University Hospital and the National School of Dairy Industry (ENIL), With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.

Conditions
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Xerostomia

Intervention / Treatment
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* Other: Dairy product
* Device: Aequasyal mouth spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old 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 psychotic illness 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dairy product<br>The product will be taken for 14 days | Other: Dairy product<br>* 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<br>|
| Active Comparator: Aequasyal mouth spray medical device<br>The spray will be taken for 14 days | Device: Aequasyal mouth spray<br>* The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of changes in mouth Dryness Score | Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Score measured at day 0, day 14, Day 21 and day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficulty in chewing | Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Score measured at day 0, day 14, Day 21 and day 35 | 
| Difficulty in swallowing | Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Score measured at day 0, day 14, Day 21 and day 35 | 
| Difficulty in speaking | Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Score measured at day 0, day 14, Day 21 and day 35 | 
| Burning sensation | Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Score measured at day 0, day 14, Day 21 and day 35 | 
| Taste perception | Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Score measured at day 0, day 14, Day 21 and day 35 | 
| Silness-Loe Index measuring dental plaque | Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Measured at day 0, day 14, Day 21 and day 35 | 
| Salivary flow | Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Measured at day 0, day 14, Day 21 and day 35 | 
| Saliva pH | Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Measured at day 0, day 14, Day 21 and day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xerostomia, Saliva, iatrogenic oral dryness, dairy product