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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)

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ClinicalTrials.gov Identifier: NCT02705937
Recruitment Status : Recruiting
First Posted : March 11, 2016
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
Ecole Nationale de l'Industrie Laitière (ENIL)
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.


Condition or disease Intervention/treatment Phase
Xerostomia Other: Dairy product Device: Aequasyal mouth spray Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 13, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arm Intervention/treatment
Experimental: Dairy product
The product will be taken for 14 days
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

Active Comparator: Aequasyal mouth spray medical device
The spray will be taken 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02705937


Contacts
Contact: Nazim NEKROUF, MD 0033.3.81.21.82.75 n1nekrouf@chu-besancon.fr
Contact: Gaelle Brunotte, PharmD gbrunotte@chu-besancon.fr

Locations
France
CHU de Besancon Recruiting
Besançon, France, 25000
Contact: Nazim NEKROUF, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Ecole Nationale de l'Industrie Laitière (ENIL)
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: Nazim NEKROUF, MD Besancon University Hospital

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02705937     History of Changes
Other Study ID Numbers: API/2015/65
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
xerostomia, Saliva, iatrogenic oral dryness, dairy product

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Psychotropic Drugs