Trial record 16 of 405 for:    Open Studies | "Mouth Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire Dijon
Centre des Sciences du Goût et de l'Alimentation
Ecole Nationale de l'Industrie Laitière
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01960101
First received: October 8, 2013
Last updated: November 8, 2013
Last verified: October 2013
  Purpose

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 Intervention
Xerostomia
Other: LactoXeros
Device: Aequasyal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Mouth Dryness Score [ Time Frame: Score measured at day 0, day 14, Day 21 and day 35 ] [ Designated as safety issue: No ]
    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:
  • Perception of other symptoms of dry mouth [ Time Frame: Day 0, 14, 21 and 35 ] [ Designated as safety issue: No ]
    difficulty chewing, swallowing and speaking, burning sensation will also be evaluated using a visual analogical scale ranging from 0 to 10 cm

  • Silness-Loe Index measuring dental plaque [ Time Frame: Day 0, 14, 21 and 35 ] [ Designated as safety issue: No ]
    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

  • Salivary flow [ Time Frame: Day 0, 14, 21 and 35 ] [ Designated as safety issue: No ]
    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.

  • Biochemical analysis of saliva [ Time Frame: Day 0, 14, 21 and 35 ] [ Designated as safety issue: No ]
    • Antioxidant power (trolox)
    • Relative quantity of MUC5B mucin
    • Amylase activity
    • Lipase activity
    • Protein concentration
    • Proteolytic activity
    • Lysozyme level

  • Analysis of the mouth coating effect [ Time Frame: Day 0, 14, 21 and 35 ] [ Designated as safety issue: No ]
    assessed by optical fiber spectrofluorimetry detecting curcumin, a food coloring agent, on the tongue

  • Release of the aroma compounds [ Time Frame: Between day 7 and 14 OR between day 28 and day 35 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 32
Study Start Date: October 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Aequasyal
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Patients allergic to curcumin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960101

Contacts
Contact: Emmanuel HAFFEN, Prof. 0033.3.81.21.83.88 emmanuel.haffen@univ-fcomte.fr
Contact: Gaelle BRUNOTTE, PharmD 0033.3.81.21.91.49 gbrunotte@chu-besancon.fr

Locations
France
Service de psychatrie adultes Recruiting
Besancon, France, 25030
Contact: Emmanuel Haffen, Prof.    00333.81.21.83.88    emmanuel.haffen@univ-fcomte.fr   
Contact: Gaelle Brunotte, PharmD    00333.81.21.91.49    gbrunotte@chu-besancon.fr   
Principal Investigator: Emmanuel Haffen, Prof.         
Service de Psychiatrie Adultes Not yet recruiting
Dijon, France, 21033
Contact: Benoit Trojak, Dr    00333.80.29.37.69    benoit.trojak@chu-dijon.fr   
Principal Investigator: Benoit Trojak, MD         
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
Investigators
Principal Investigator: Emmanuel Haffen, Prof. Centre Hospitalier Universitaire de Besancon
  More Information

No publications provided

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
Study First Received: October 8, 2013
Last Updated: November 8, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Xerostomia
Stress, Psychological
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014