XerostomiaLactoXerosNCT01960101
Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication
A study testing LactoXeros and Aequasyal in people with Xerostomia, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- LactoXeros and Aequasyal
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Incapacitated adults
- Patients placed under tutorship or curatorship
- Patients under judicial protection
- Patients suffering from milk allergy or lactose intolerance
- Patients allergic to curcumin
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de psychatrie adultes
Besançon, 25030
Service de Psychiatrie Adultes
Dijon, 21033
About this study
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.
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.
Read more
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.
- Conditions
- Xerostomia
- Being tested
- LactoXeros, Aequasyal
- Keywords
- xerostomia, Saliva, iatrogenic oral dryness, antidepressants, mouth dryness, milk product
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoXerosOther
AequasyalDevice
| Study group | Role | What they receive |
|---|---|---|
| Lactoxeros milk product | Experimental | Patient will take the milk product orally for 14 days as many times as needed per day(but not more than 6 times daily). Receives: Other: LactoXeros |
| Aequasyal | Other | 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. Receives: Device: Aequasyal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth Dryness Score
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
Measured: Score measured at day 0, day 14, Day 21 and day 35
Secondary outcomes (6)
Perception of other symptoms of dry mouth
difficulty chewing, swallowing and speaking, burning sensation will also be evaluated using a visual analogical scale ranging from 0 to 10 cm
Measured: Day 0, 14, 21 and 35
Silness-Loe Index measuring dental plaque
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
Measured: Day 0, 14, 21 and 35
Salivary flow
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.
Measured: Day 0, 14, 21 and 35
Biochemical analysis of saliva
- Antioxidant power (trolox)
- Relative quantity of MUC5B mucin
- Amylase activity
- Lipase activity
- Protein concentration
- Proteolytic activity
- Lysozyme level
Measured: Day 0, 14, 21 and 35
Analysis of the mouth coating effect
assessed by optical fiber spectrofluorimetry detecting curcumin, a food coloring agent, on the tongue
Measured: Day 0, 14, 21 and 35
Release of the aroma compounds
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.
Measured: Between day 7 and 14 OR between day 28 and day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire Dijon, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Ecole Nationale de l'Industrie Laitière
- Responsible party
- Sponsor
- Investigators
- Emmanuel Haffen, Prof., Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960101
- Sponsor's protocol ID
- C12-58
- Other IDs
- 2012-A01686-37
- Acronym
- LactoXeros
- Status last verified
- Dec 2015
- First submitted
- 8 Oct 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01960101
- Acronym / sponsor ID
- LactoXeros / C12-58
- Conditions
- Xerostomia
- Keywords
- xerostomia, Saliva, iatrogenic oral dryness, antidepressants, mouth dryness, milk product
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire Dijon, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Ecole Nationale de l'Industrie Laitière
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (estimated)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactoxeros milk product | Experimental | Other: LactoXerosPatient will take the milk product orally for 14 days as many times as needed per day(but not more than 6 times daily). |
| Aequasyal | Other | Device: AequasyalPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactoXeros | Other | Lactoxeros milk product |
| Aequasyal | Device | Aequasyal |
Primary outcome
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
6 secondary outcomes
Perception of other symptoms of dry mouth
Time frame: Day 0, 14, 21 and 35
Silness-Loe Index measuring dental plaque
Time frame: Day 0, 14, 21 and 35
Salivary flow
Time frame: Day 0, 14, 21 and 35
Biochemical analysis of saliva
Time frame: Day 0, 14, 21 and 35
Analysis of the mouth coating effect
Time frame: Day 0, 14, 21 and 35
Release of the aroma compounds
Time frame: Between day 7 and 14 OR between day 28 and day 35
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Haffen, Prof. principal investigator
Centre Hospitalier Universitaire de Besancon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LactoXeros and Aequasyal in people with Xerostomia, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth Dryness Score (time frame: Score measured at day 0, day 14, Day 21 and day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015; AzTrials last refreshed its copy on 26 Oct 2026.