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

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.

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01960101
Acronym
LactoXeros
Enrollment
0
Registered
2013-10-10
Start date
2013-10-31
Completion date
Unknown
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia

Keywords

xerostomia, Saliva, iatrogenic oral dryness, antidepressants, mouth dryness, milk product

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.

Interventions

OTHERLactoXeros
DEVICEAequasyal

Sponsors

Centre Hospitalier Universitaire de Besancon
CollaboratorOTHER
Centre Hospitalier Universitaire Dijon
CollaboratorOTHER
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
CollaboratorOTHER
Ecole Nationale de l'Industrie Laitière
CollaboratorUNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Mouth Dryness ScoreScore measured at day 0, day 14, Day 21 and day 35The 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

MeasureTime frameDescription
Silness-Loe Index measuring dental plaqueDay 0, 14, 21 and 35The 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 flowDay 0, 14, 21 and 35People 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.
Perception of other symptoms of dry mouthDay 0, 14, 21 and 35difficulty chewing, swallowing and speaking, burning sensation will also be evaluated using a visual analogical scale ranging from 0 to 10 cm
Analysis of the mouth coating effectDay 0, 14, 21 and 35assessed by optical fiber spectrofluorimetry detecting curcumin, a food coloring agent, on the tongue
Release of the aroma compoundsBetween day 7 and 14 OR between day 28 and day 35This 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.
Biochemical analysis of salivaDay 0, 14, 21 and 35* Antioxidant power (trolox) * Relative quantity of MUC5B mucin * Amylase activity * Lipase activity * Protein concentration * Proteolytic activity * Lysozyme level

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026