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

12. maj 2021 opdateret af: University Hospital, Brest
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Brest, Frankrig, 29609
        • CHRU Brest

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PREDELFI Film
Enhed: 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 komparator: CONTROL Film
Enhed: CONTROL
It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tolerance evaluation
Tidsramme: 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
day 90

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oral comfort
Tidsramme: day 90
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
Tidsramme: day 90
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
Tidsramme: day 90
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
Tidsramme: day 90
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
Tidsramme: day 90
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Brest

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. juni 2020

Primær færdiggørelse (Faktiske)

23. april 2021

Studieafslutning (Faktiske)

23. april 2021

Datoer for studieregistrering

Først indsendt

10. december 2019

Først indsendt, der opfyldte QC-kriterier

18. december 2019

Først opslået (Faktiske)

20. december 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 29BRC18.0037 (PREDELFI)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

All collected data that underlie results in a publication

IPD-delingstidsramme

Data will be available beginning five years and ending fifteen years following the final study report completion

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • Studieprotokol

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Betingelser

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