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临床试验/NCT02705937
NCT02705937Unknown不适用

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.

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年9月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
32
试验地点
2
主要终点
Comparison of changes in mouth Dryness Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Incapacitated adults
  • Patients placed under tutorship or curatorship
  • Patients under judicial protection
  • Patients suffering from milk allergy or lactose intolerance

研究组 & 干预措施

Dairy product

Experimental

The product will be taken for 14 days

干预措施: Dairy product (Other)

Aequasyal mouth spray medical device

Active Comparator

The spray will be taken for 14 days

干预措施: Aequasyal mouth spray (Device)

结局指标

主要结局

Comparison of changes in mouth Dryness Score

时间窗: 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

次要结局

  • Difficulty in chewing(Score measured at day 0, day 14, Day 21 and day 35)
  • Difficulty in swallowing(Score measured at day 0, day 14, Day 21 and day 35)
  • Difficulty in speaking(Score measured at day 0, day 14, Day 21 and day 35)
  • Burning sensation(Score measured at day 0, day 14, Day 21 and day 35)
  • Taste perception(Score measured at day 0, day 14, Day 21 and day 35)
  • Silness-Loe Index measuring dental plaque(Measured at day 0, day 14, Day 21 and day 35)
  • Salivary flow(Measured at day 0, day 14, Day 21 and day 35)
  • Saliva pH(Measured at day 0, day 14, Day 21 and day 35)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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