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.

Xerostomia Clinical Trial

— LactoXeros  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705937
• Other study ID #: API/2015/65
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2016
• Last updated: October 5, 2017
• Start date: September 13, 2017
• Est. completion date: March 2019

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Nazim NEKROUF, MD
• Phone: 0033.3.81.21.82.75
• Email: n1nekrouf[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Xerostomia

Intervention

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

Locations

Country	Name	City	State
France	CHU de Besancon	Besançon

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Centre Hospitalier Universitaire Dijon, Ecole Nationale de l'Industrie Laitière (ENIL)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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