Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication

Study Overview
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Brief Summary
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Dry mouth is in most cases due to iatrogenic causes, particularly drugs. The existing products such as saliva substitutes are often disappointing (bad taste, poor efficiency). Our hypothesis has considered the empirical observations made by some patients with xerostomia who consumed milk products to relieve the dry mouth syndrome from which they suffered. With this clinical observation, a closer collaboration has been undertaken with research laboratories specialising in food and especially milk. 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 elements related to the phenomena of consumption of food as an alternative to medication. In the latter, 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 natural milk, which is the subject of this application for development, to qualify and adapt a product with a health benefit in patients suffering from xerostomia. To further develop this project we will initiate a sequential clinical trial by groups of five ambulatory patients with xerostomia (patients taking antidepressants followed in psychiatry appointments). The clinical tests will be organised by the CIC with the psychiatric wards of the University Hospital of Besançon. Each group of 5 patients will test a similar product for 14 days. The information collected after a series of tests with a group of patients will be translated by changing the ENIL specifications to produce a new mini-series of products. This repetition will be carried out up to 3 times if necessary to help achieve a satisfactory product in terms of taste, texture and lubrication properties, which will then be tested in a randomized controlled cross-over study of the efficiency and acceptability of the new LactoXeros product versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at the University hospital of Dijon. A natural way to combat xerostomia at the interface of patient diet, such as we propose, could help improve quality of life for patients, minimize harmful effects (infection, decay) and promote adherence of patients to treatments which are responsible for xerostomia.

Official Title
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Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Psychotropic Drugs and Comparison of Its Efficiency With the Use of Aequasyal (Oxidized Glycerol Triester)Spray.

Conditions
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Xerostomia

Intervention / Treatment
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* Other: LactoXeros
* Device: Aequasyal


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 Patients allergic to curcumin

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: Lactoxeros milk product<br>Patient will take the milk product orally for 14 days as many times as needed per day(but not more than 6 times daily). | Other: LactoXeros<br> <br> |
| Other: Aequasyal<br>Patients will take the oral spray for 14 days. The Aequasyal ® Oral Spray is a solution of oxidized glycerol triesters. The oral spray is applied by spraying on the inside of each cheek, 3-4 times per day. After each administration, users are instructed to gently spread the product around the mouth with the tongue. The Aequasyal ® Oral Spray is a Class I medical device, and is CE-marked. | Device: Aequasyal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mouth Dryness Score | The mouth dryness score will be evaluated using a visual analogical scale (scale increased from 0 to 10 cm). The value 0 refers to normal mouth dampness (absence of dry mouth symptoms) and value 10 represents the worst imaginable dry mouth symptoms. This score is specific, sensitive and reproducible | Score measured at day 0, day 14, Day 21 and day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of other symptoms of dry mouth | difficulty chewing, swallowing and speaking, burning sensation will also be evaluated using a visual analogical scale ranging from 0 to 10 cm | Day 0, 14, 21 and 35 | 
| Silness-Loe Index measuring dental plaque | The oral examination will be performed by a dentist. During the inspection, the Silness Loe plaque index will be measured. The appearance of the oral tissue (redness, dryness) will be assessed using an ordinal 4-point scale as follows: 0 = none, 1 mild, 2 = moderate, 3 = severe | Day 0, 14, 21 and 35 | 
| Salivary flow | People will be asked to spit in a collector tube for 8 minutes (2 sessions of 4 minutes separated by a 5-minute break). The saliva will be weighed and the salivary flow will then be calculated in g/min. | Day 0, 14, 21 and 35 | 
| Biochemical analysis of saliva | Antioxidant power (trolox) Relative quantity of MUC5B mucin Amylase activity Lipase activity Protein concentration Proteolytic activity Lysozyme level | Day 0, 14, 21 and 35 | 
| Analysis of the mouth coating effect | assessed by optical fiber spectrofluorimetry detecting curcumin, a food coloring agent, on the tongue | Day 0, 14, 21 and 35 | 
| Release of the aroma compounds | This will be done only once and only when patients will be taking the experimental milk product (not with the Aequasyal product). Atmospheric Pressure Ionization Mass Spectrometry (API-MS) will be used for the continuous analysis of the retro-nasal release of flavor (nosespace) when chewing a sample of the milk product. | Between day 7 and 14 OR between day 28 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, antidepressants, mouth dryness, milk product