Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study (PREDELFI)

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia; Sicca Syndrome
• Intervention / Treatment: Device: PREDELFI; Device: CONTROL

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PREDELFI Film	Device: PREDELFI; 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
Placebo Comparator: CONTROL Film	Device: CONTROL; It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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,...)	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.	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)	day 90

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): April 23, 2021
• Study Completion (Actual): April 23, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: prebiotics; natural film
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Salivary Gland Diseases; Dry Eye Syndromes; Sjogren's Syndrome; Xerostomia
• Other Study ID Numbers: 29BRC18.0037 (PREDELFI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No