Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01960101
Status:
WITHDRAWN
Last Update Posted:
2015-12-03
First Post:
2013-10-08
Brief Title:
Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
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 TriesterSpray
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LactoXeros
Brief 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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-A01686-37 | REGISTRY | IDRCB | None |