XerostomiaLactoXerosNCT02705937
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.
A study testing Dairy product and Aequasyal mouth spray in people with Xerostomia, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia
- What is being tested?
- Dairy product and Aequasyal mouth spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2017to Mar 2019
- 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 10Show fewer
- Incapacitated adults
- Patients placed under tutorship or curatorship
- Patients under judicial protection
- Patients suffering from milk allergy or lactose intolerance
Trial locations and contacts
1 site in 1 country.
Gaelle Brunotte, PharmD contact
France1 site, 1 recruiting
- Recruiting
CHU de Besancon
Besançon, 25000
Nazim NEKROUF, MD
About this study
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.
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.
Read more
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.
- Conditions
- Xerostomia
- Being tested
- Dairy product, Aequasyal mouth spray
- Keywords
- xerostomia, Saliva, iatrogenic oral dryness, dairy product
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy productOther
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
Aequasyal mouth sprayDevice
The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Dairy product | Experimental | The product will be taken for 14 days Receives: Other: Dairy product |
| Aequasyal mouth spray medical device | Active comparator | The spray will be taken for 14 days Receives: Device: Aequasyal mouth spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of changes in mouth Dryness Score
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
Measured: Score measured at day 0, day 14, Day 21 and day 35
Secondary outcomes (8)
Difficulty in chewing
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
Measured: Score measured at day 0, day 14, Day 21 and day 35
Difficulty in swallowing
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
Measured: Score measured at day 0, day 14, Day 21 and day 35
Difficulty in speaking
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
Measured: Score measured at day 0, day 14, Day 21 and day 35
Burning sensation
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
Measured: Score measured at day 0, day 14, Day 21 and day 35
Taste perception
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
Measured: Score measured at day 0, day 14, Day 21 and day 35
Silness-Loe Index measuring dental plaque
Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Measured: Measured at day 0, day 14, Day 21 and day 35
Salivary flow
Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Measured: Measured at day 0, day 14, Day 21 and day 35
Saliva pH
Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Measured: Measured at day 0, day 14, Day 21 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 posted11 Mar 2016 (estimated)
- Study start13 Sep 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (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 Centre Hospitalier Universitaire de BesanconThe 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Nationale de l'Industrie Laitière (ENIL), Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- Nazim NEKROUF, MD, Principal investigator, Besancon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705937
- Sponsor's protocol ID
- API/2015/65
- Acronym
- LactoXeros
- Status last verified
- Oct 2017
- First submitted
- 3 Feb 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02705937
- Acronym / sponsor ID
- LactoXeros / API/2015/65
- Conditions
- Xerostomia
- Keywords
- xerostomia, Saliva, iatrogenic oral dryness, dairy product
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Ecole Nationale de l'Industrie Laitière (ENIL), Centre Hospitalier Universitaire Dijon
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 11 Mar 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy product | Experimental | Other: Dairy productThe product will be taken for 14 days |
| Aequasyal mouth spray medical device | Active comparator | Device: Aequasyal mouth sprayThe spray will be taken for 14 days |
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 (10 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 |
|---|---|---|
| Dairy productDairy 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 | Other | Dairy product |
| Aequasyal mouth sprayThe mouth spray will be used by patients as needed (according to the package leaflet) for 14 days | Device | Aequasyal mouth spray medical device |
Primary outcome
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
8 secondary outcomes
Difficulty in chewing
Time frame: Score measured at day 0, day 14, Day 21 and day 35
Difficulty in swallowing
Time frame: Score measured at day 0, day 14, Day 21 and day 35
Difficulty in speaking
Time frame: Score measured at day 0, day 14, Day 21 and day 35
Burning sensation
Time frame: Score measured at day 0, day 14, Day 21 and day 35
Taste perception
Time frame: Score measured at day 0, day 14, Day 21 and day 35
Silness-Loe Index measuring dental plaque
Time frame: Measured at day 0, day 14, Day 21 and day 35
Salivary flow
Time frame: Measured at day 0, day 14, Day 21 and day 35
Saliva pH
Time frame: Measured at day 0, day 14, Day 21 and day 35
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
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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.
Gaelle Brunotte, PharmD contact
Nazim NEKROUF, MD principal investigator
Besancon University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy product and Aequasyal mouth spray in people with Xerostomia, run by Centre Hospitalier Universitaire de Besancon at 1 site 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 10 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: status not confirmed, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazim NEKROUF, MD (0033.3.81.21.82.75, n1nekrouf@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of changes in 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 6 Oct 2017.