Clinical trial NCT02705937: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Xerostomia
Keywords: xerostomia, Saliva, iatrogenic oral dryness, dairy product
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Ecole Nationale de l'Industrie Laitière (ENIL)
name: Centre Hospitalier Universitaire Dijon
First posted: 2016-03-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of changes in mouth Dryness Score
timeFrame: Score measured at day 0, day 14, Day 21 and day 35
Secondary outcomes:
measure: Difficulty in chewing
timeFrame: Score measured at day 0, day 14, Day 21 and day 35
measure: Difficulty in swallowing
timeFrame: Score measured at day 0, day 14, Day 21 and day 35
measure: Difficulty in speaking
timeFrame: Score measured at day 0, day 14, Day 21 and day 35
measure: Burning sensation
timeFrame: Score measured at day 0, day 14, Day 21 and day 35
measure: Taste perception
timeFrame: Score measured at day 0, day 14, Day 21 and day 35
measure: Silness-Loe Index measuring dental plaque
timeFrame: Measured at day 0, day 14, Day 21 and day 35
measure: Salivary flow
timeFrame: Measured at day 0, day 14, Day 21 and day 35
measure: Saliva pH
timeFrame: Measured at day 0, day 14, Day 21 and day 35
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besancon
Study officials:
affiliation: Besancon University Hospital
name: Nazim NEKROUF, MD
role: PRINCIPAL_INVESTIGATOR
References: