Sicca SyndromePREDELFINCT04206826
Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
A study testing PREDELFI in people with Sicca Syndrome and Xerostomia, run by University Hospital, Brest at 1 site in France.
Trial summary
Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sicca Syndrome, Xerostomia
- What is being tested?
- PREDELFI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2020to 23 Apr 2021
- 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
- Men or women aged 18 or over
- Complaining of xerostomia and validated by a standardized question
- With hyposialia diagnosed by the measurement of stimulated salivary flow (DSS) and unstimulated (DNS)
- Patient having signed a consent
- Registered with Social Security
Who cannot join
- The patient having known sensitivity to any of the products or components of the biofilms (milk protein, soy derivatives, sodium alginate, vegetable glycerin, caramel and beta carotene)
- Allergic to birch and / or peanut
- Having an ethyl intoxication (> 2 glasses of wine / day), smoking (> 10 cigarettes / day)
- Unable to complete self-assessment questionnaires or to follow study protocol procedures (unable to read and / or write).
- Participant in another clinical study at the time of inclusion or having participated in the 30 days preceding recruitment in this study
- Having a life-threatening condition for the duration of the study
Show all 9Show fewer
- Treated with sialogogues (pilocarpine hydrochloride) within 30 days prior to inclusion
- Using salivary substitutes
- Protected persons within the law (articles L1121-5 to L1121-8)
Trial locations and contacts
1 site in 1 country.
About this study
Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. It handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. This dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. Today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. This study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.
Read the detailed description
The purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film.
The primary endpoint is the assessment of tolerability assessed using a visual analogue scale (VAS) from 0 to 100 at the end of the 1-month period of both treatment periods (D30 and D90). In this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed.
Each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.
- Conditions
- Sicca Syndrome, Xerostomia
- Being tested
- PREDELFI, CONTROL
- Keywords
- natural film, prebiotics
- Medical subject headings
- Sjogren's Syndrome, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREDELFIDevice
It's a natural film which contains a concentrated alpha-GOS (alpha-galacto-oligosaccharide) soy extract, a milk protein concentrate containing caseins and whey proteins and vegetable glycerin
CONTROLDevice
It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.
| Study group | Role | What they receive |
|---|---|---|
| PREDELFI Film | Experimental | Not described Receives: Device: PREDELFI |
| CONTROL Film | Placebo comparator | Not described Receives: Device: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance evaluation
The primary endpoint is a composite endpoint of tolerance evaluation defined by:
- the patient (EVA from 0 to 100),
- the investigator (degree of redness and inflammation of the mucous membranes opposite the site of the device,
- reporting adverse events related to the device
Measured: day 90
Secondary outcomes (5)
Oral comfort
Self-evaluation of the patient's oral dryness (oral comfort) using a 100mm visual analogue scale (measurement of the absolute variation at the beginning and end of each treatment period)
Measured: day 90
Subjective evaluation of dry mouth
Subjective evaluation of the absolute variation of the specific signs and symptoms of dry mouth (difficulty speaking, chewing swallowing, taste alteration, burning sensations) using 100 mm analogue visual scales
Measured: day 90
Clinical assessment of the mucous
Objective clinical assessment of the general condition of the mucous membranes (redness, dryness, degree of inflammation of periodontal tissues, mucous membranes,...)
Measured: day 90
Evaluation of salivary flow
Objective evaluation of the absolute variation of the stimulated and unstimulated salivary flow rates according to the dosage forms used and the variation of the oral pH using specific strips.
Measured: day 90
Evaluation of the salivary microbiota
Evaluation by molecular sequencing of the salivary microbiota to study the impact of the film on the modification of the salivary microbiota (quantification of the different species by NGS)
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start25 Jun 2020
- Primary completion23 Apr 2021
- Study completion23 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sicca SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Model description
- Each patient will apply the two films (PreDelfi and control according to randomization) at the level of the gingival mucosa next to the maxillary vestibule for 30 days
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206826
- Sponsor's protocol ID
- 29BRC18.0037 (PREDELFI)
- Acronym
- PREDELFI
- Status last verified
- May 2021
- First submitted
- 10 Dec 2019
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Orliaguet M, Fong SB, Le Pottier L, Meuric V, Boisrame S, Bonnaure-Mallet M, Pers JO. Tolerance to intraoral biofilms and their effectiveness in improving mouth dryness and modifying oral microbiota in patients with primary Sjogren's syndrome: "Predelfi study". Front Microbiol. 2023 Feb 8;14:1071683. doi: 10.3389/fmicb.2023.1071683. eCollection 2023.
PubMed 37293235
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT04206826
- Acronym / sponsor ID
- PREDELFI / 29BRC18.0037 (PREDELFI)
- Conditions
- Sicca Syndrome, Xerostomia
- Keywords
- natural film, prebiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 23 Apr 2021 (actual)
- First posted
- 20 Dec 2019 (actual)
- 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.
Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. It handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. This dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. Today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. This study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.
Detailed description
The purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film.
The primary endpoint is the assessment of tolerability assessed using a visual analogue scale (VAS) from 0 to 100 at the end of the 1-month period of both treatment periods (D30 and D90). In this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed.
Each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Each patient will apply the two films (PreDelfi and control according to randomization) at the level of the gingival mucosa next to the maxillary vestibule for 30 days
| Arm | Type | Receives |
|---|---|---|
| PREDELFI Film | Experimental | Device: PREDELFI |
| CONTROL Film | Placebo comparator | Device: CONTROL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women aged 18 or over
- Complaining of xerostomia and validated by a standardized question
- With hyposialia diagnosed by the measurement of stimulated salivary flow (DSS) and unstimulated (DNS)
- Patient having signed a consent
- Registered with Social Security
Key exclusion criteria (9 listed)
- The patient having known sensitivity to any of the products or components of the biofilms (milk protein, soy derivatives, sodium alginate, vegetable glycerin, caramel and beta carotene)
- Allergic to birch and / or peanut
- Having an ethyl intoxication (> 2 glasses of wine / day), smoking (> 10 cigarettes / day)
- Unable to complete self-assessment questionnaires or to follow study protocol procedures (unable to read and / or write).
- Participant in another clinical study at the time of inclusion or having participated in the 30 days preceding recruitment in this study
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 |
|---|---|---|
| PREDELFIIt's a natural film which contains a concentrated alpha-GOS (alpha-galacto-oligosaccharide) soy extract, a milk protein concentrate containing caseins and whey proteins and vegetable glycerin | Device | PREDELFI Film |
| CONTROLIt's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water. | Device | CONTROL Film |
Primary outcome
Tolerance evaluation
Time frame: day 90
The primary endpoint is a composite endpoint of tolerance evaluation defined by: * the patient (EVA from 0 to 100), * the investigator (degree of redness and inflammation of the mucous membranes opposite the site of the device, * reporting adverse events related to the device
5 secondary outcomes
Oral comfort
Time frame: day 90
Subjective evaluation of dry mouth
Time frame: day 90
Clinical assessment of the mucous
Time frame: day 90
Evaluation of salivary flow
Time frame: day 90
Evaluation of the salivary microbiota
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 37293235Orliaguet M, Fong SB, Le Pottier L, Meuric V, Boisrame S, Bonnaure-Mallet M, Pers JO. Tolerance to intraoral biofilms and their effectiveness in improving mouth dryness and modifying oral microbiota in patients with primary Sjogren's syndrome: "Predelfi study". Front Microbiol. 2023 Feb 8;14:1071683. doi: 10.3389/fmicb.2023.1071683. eCollection 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREDELFI in people with Sicca Syndrome and Xerostomia, run by University Hospital, Brest 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 5 Feb 2025. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tolerance evaluation (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04206826, which also lists 1 linked publication.
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 5 Feb 2025.