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. (LactoXeros)

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.

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Besançon, France, 25000
        • Recruiting
        • CHU de Besançon
        • Contact:
          • Nazim NEKROUF, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of changes in mouth Dryness Score
Time Frame: Score measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Score measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Score measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Score measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Score measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Score measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Measured at day 0, day 14, Day 21 and day 35
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
Time Frame: Measured at day 0, day 14, Day 21 and day 35
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nazim NEKROUF, MD, Besançon University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Xerostomia

Clinical Trials on Dairy product

3
Subscribe