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Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication (LactoXeros)

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ClinicalTrials.gov Identifier: NCT01960101
Recruitment Status : Withdrawn
First Posted : October 10, 2013
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

Dry mouth is in most cases due to iatrogenic causes, particularly drugs. The existing products such as saliva substitutes are often disappointing (bad taste, poor efficiency).

Our hypothesis has considered the "empirical" observations made by some patients with xerostomia who consumed milk products to relieve the dry mouth syndrome from which they suffered. With this clinical observation, a closer collaboration has been undertaken with research laboratories specialising in food and especially milk. 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 elements related to the phenomena of consumption of food as an alternative to medication. In the latter, 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 natural milk, which is the subject of this application for development, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia.

To further develop this project we will initiate a sequential clinical trial by groups of five ambulatory patients with xerostomia (patients taking antidepressants followed in psychiatry appointments). The clinical tests will be organised by the CIC with the psychiatric wards of the University Hospital of Besançon. Each group of 5 patients will test a similar product for 14 days. The information collected after a series of tests with a group of patients will be translated by changing the ENIL specifications to produce a new mini-series of products. This repetition will be carried out up to 3 times if necessary to help achieve a satisfactory product in terms of taste, texture and lubrication properties, which will then be tested in a randomized controlled cross-over study of the efficiency and acceptability of the new "LactoXeros" product versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at the University hospital of Dijon.

A natural way to combat xerostomia at the interface of patient diet, such as we propose, could help improve quality of life for patients, minimize harmful effects (infection, decay) and promote adherence of patients to treatments which are responsible for xerostomia.

Condition or disease Intervention/treatment
Xerostomia Other: LactoXeros Device: Aequasyal

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Psychotropic Drugs and Comparison of Its Efficiency With the Use of Aequasyal (Oxidized Glycerol Triester)Spray.
Study Start Date : October 2013
Estimated Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lactoxeros milk product
Patient will take the milk product orally for 14 days as many times as needed per day(but not more than 6 times daily).
Other: LactoXeros
Patients will take the oral spray for 14 days. The Aequasyal ® Oral Spray is a solution of oxidized glycerol triesters. The oral spray is applied by spraying on the inside of each cheek, 3-4 times per day. After each administration, users are instructed to gently spread the product around the mouth with the tongue. The Aequasyal ® Oral Spray is a Class I medical device, and is CE-marked.
Device: Aequasyal

Outcome Measures

Primary Outcome Measures :
  1. Mouth Dryness Score [ Time Frame: Score measured at day 0, day 14, Day 21 and day 35 ]
    The mouth dryness score will be evaluated using a visual analogical scale (scale increased from 0 to 10 cm). The value 0 refers to normal mouth dampness (absence of dry mouth symptoms) and value 10 represents "the worst imaginable" dry mouth symptoms. This score is specific, sensitive and reproducible

Secondary Outcome Measures :
  1. Perception of other symptoms of dry mouth [ Time Frame: Day 0, 14, 21 and 35 ]
    difficulty chewing, swallowing and speaking, burning sensation will also be evaluated using a visual analogical scale ranging from 0 to 10 cm

  2. Silness-Loe Index measuring dental plaque [ Time Frame: Day 0, 14, 21 and 35 ]
    The oral examination will be performed by a dentist. During the inspection, the Silness Loe plaque index will be measured. The appearance of the oral tissue (redness, dryness) will be assessed using an ordinal 4-point scale as follows: 0 = none, 1 mild, 2 = moderate, 3 = severe

  3. Salivary flow [ Time Frame: Day 0, 14, 21 and 35 ]
    People will be asked to spit in a collector tube for 8 minutes (2 sessions of 4 minutes separated by a 5-minute break). The saliva will be weighed and the salivary flow will then be calculated in g/min.

  4. Biochemical analysis of saliva [ Time Frame: Day 0, 14, 21 and 35 ]
    • Antioxidant power (trolox)
    • Relative quantity of MUC5B mucin
    • Amylase activity
    • Lipase activity
    • Protein concentration
    • Proteolytic activity
    • Lysozyme level

  5. Analysis of the mouth coating effect [ Time Frame: Day 0, 14, 21 and 35 ]
    assessed by optical fiber spectrofluorimetry detecting curcumin, a food coloring agent, on the tongue

  6. Release of the aroma compounds [ Time Frame: Between day 7 and 14 OR between day 28 and day 35 ]

    This will be done only once and only when patients will be taking the experimental milk product (not with the Aequasyal product).

    Atmospheric Pressure Ionization Mass Spectrometry (API-MS) will be used for the continuous analysis of the retro-nasal release of flavor (nosespace) when chewing a sample of the milk product.

Eligibility Criteria

Information from the National Library of Medicine

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

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
  • Patients allergic to curcumin
Contacts and Locations

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): NCT01960101

Service de psychatrie adultes
Besancon, France, 25030
Service de Psychiatrie Adultes
Dijon, France, 21033
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire Dijon
Centre des Sciences du Goût et de l'Alimentation
Ecole Nationale de l'Industrie Laitière
Principal Investigator: Emmanuel Haffen, Prof. Centre Hospitalier Universitaire de Besancon
More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01960101     History of Changes
Other Study ID Numbers: C12-58
2012-A01686-37 ( Registry Identifier: IDRCB )
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
iatrogenic oral dryness
mouth dryness
milk product

Additional relevant MeSH terms:
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs