- ICH GCP
- US Clinical Trials Registry
- 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. (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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nazim NEKROUF, MD
- Phone Number: 0033.3.81.21.82.75
- Email: n1nekrouf@chu-besancon.fr
Study Contact Backup
- Name: Gaelle Brunotte, PharmD
- Email: gbrunotte@chu-besancon.fr
Study Locations
-
-
-
Besançon, France, 25000
- Recruiting
- CHU de Besançon
-
Contact:
- Nazim NEKROUF, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Nazim NEKROUF, MD, Besançon University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- API/2015/65
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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