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Oral Sphere: Salivary Markers and Food. A Prospective Study in Children Expressing Oral Disorders (ORALISENS)

Primary Purpose

Oral Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Taking of saliva before and after gustatory stimulation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oral Disorder focused on measuring Oral disorders

Eligibility Criteria

2 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Oral disorder children group:

  • Oral disorder children, of any etiology, defined as follows:

difficulty to wean the nutritional support within 50% of energy intake recommended by age oral more than 3 months of exclusive artificial feeding during the first 6 months of life

  • Children aged 2 to 15 years
  • Children with a maximum of 50% of their energy intake provided by the oral route (3 or 4 patients with 0% intake, defined as an internal control)
  • Whose parents gave consent for study participation

No oral disorder children group:

  • No oral disorder children
  • whose parents signed an informed consent for the participation of their child to the study

Exclusion Criteria:

Oral disorder children group:

  • Child refusing to participate
  • Absence of parents consent
  • Less than 3 months of artificial feeding during the first 6 months of life,
  • Immunosuppressive medication that might interfere with the saliva composition,
  • Children not covered by the social security

No oral disorder children group:

  • Child refusing to participate
  • Absence of parents consent
  • History of or current enteral or parenteral feeding.
  • Children not covered by the social security

No oral disorder children are matched to Oral disorder children on age and sex.

Sites / Locations

  • Service de Gastroentérologie, hépatologie et nutrition Hopital Femme Mere Enfant

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral disorder children

Control group

Arm Description

Oral disorder children aged 2 to 15 years

No oral disorder children aged 2 to 15 years

Outcomes

Primary Outcome Measures

Change in lipase, protease, amylase and lysosomal activity, metabolomic, proteomic or peptidic analysis on saliva samples at enrolment, and at months 3, 6, 9 and 12

Secondary Outcome Measures

change in enzyme activities, metabolomic, proteomic and peptidic analysis before and after acidic stimulation of saliva at enrolment, and at months 3, 6, 9 and 12.
Types of diet and eating habits questionnaire
Evolution of lipase, protease, amylase and lysosomal activity and metabolomic, proteomic and peptidic analysis of saliva at enrolment, and at months 3, 6, 9 and 12.

Full Information

First Posted
January 31, 2012
Last Updated
May 23, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01532323
Brief Title
Oral Sphere: Salivary Markers and Food. A Prospective Study in Children Expressing Oral Disorders
Acronym
ORALISENS
Official Title
Oral Sphere: Salivary Markers and Food. A Prospective Study in Children Expressing Oral Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In Human, the oral sphere is the first and main place where sensory stimuli are received and perceived. The phenomena occuring during food breakdown and sensory perception are complex and in this system saliva plays a major role. In the neonatal period, severe digestive diseases require the cessation of all oral feeding and the use of enteral or parenteral nutrition for prolonged periods to ensure the growth and development of children while their disease is active. The early stages of sensory oral exposures and their consequences on the development of eating habits of these children are poorly documented. It is likely that the process of acquisition of preferences and eating habits is atypical because of a "bypass" of the oral sphere during the early stages of feeding. Thus, if not orally fed, children do not get exposed to a wide variety of tastes and textures in the first year of life, which may impact on their oral acceptance at a later age. These oral disorders (OD) are expressed by a refusal to eat, a heightened gag reflex, a refusal of certain consistencies and difficulties in chewing and swallowing. Few data are available on food typically accepted by these children. Finally, oral sensory phenotypes of OD children (gustatory sensitivity ...) have not been described yet. It is likely that they may differ significantly from those of healthy (NOD). In this context, a population of OD children is particularly interesting for studying the effects of the absence of these learning stages and their consequences in the development of sensory perception and eating habits. The investigators formulate the hypothesis that the lack of exposure to a standard oral diet would modify the development of their "oro-sensory systems" including saliva. Studying such a population is a great opportunity to assess the influence of non oral food exposures and diet on saliva characteristics. Saliva has recently received attention as a potential easy to collect source of biomarkers in several conditions excluding OD. The potential impact of OD on salivary composition has never been studied. Several studies linking saliva and perception or preferences have been conducted in the UMR CSGA (Unité Mixte de Recherche du Centre des Sciences du Goût et de l'Alimentation). They have already contributed to highlight the great inter-individual variability for a number of saliva markers and a change in saliva protein profiles in response to taste stimulation They also underlined the remarkable intra-stability for saliva flow and composition during a one year study. This study intends to prove the concept that it is relevant to relate saliva characteristics to food intake behaviour or food habits The first hypothesis to be tested in this study is that salivary profiles (biological signatures) can discriminate two groups of children differing by their orality. The second hypothesis to be tested is that these specific biological biological signatures may be correlated to certain food habits associated or not with oral disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Disorder
Keywords
Oral disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral disorder children
Arm Type
Experimental
Arm Description
Oral disorder children aged 2 to 15 years
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
No oral disorder children aged 2 to 15 years
Intervention Type
Other
Intervention Name(s)
Taking of saliva before and after gustatory stimulation
Intervention Description
Taking of saliva before and after gustatory stimulation (3 drops of citric acid 2.4 g / L)
Primary Outcome Measure Information:
Title
Change in lipase, protease, amylase and lysosomal activity, metabolomic, proteomic or peptidic analysis on saliva samples at enrolment, and at months 3, 6, 9 and 12
Time Frame
at enrolment, and at months 3, 6, 9 and 12
Secondary Outcome Measure Information:
Title
change in enzyme activities, metabolomic, proteomic and peptidic analysis before and after acidic stimulation of saliva at enrolment, and at months 3, 6, 9 and 12.
Time Frame
at enrolment, and at months 3, 6, 9 and 12
Title
Types of diet and eating habits questionnaire
Time Frame
at enrolment, 6 months and 12 months after enrolment
Title
Evolution of lipase, protease, amylase and lysosomal activity and metabolomic, proteomic and peptidic analysis of saliva at enrolment, and at months 3, 6, 9 and 12.
Time Frame
at enrolment, and at months 3, 6, 9 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Oral disorder children group: Oral disorder children, of any etiology, defined as follows: difficulty to wean the nutritional support within 50% of energy intake recommended by age oral more than 3 months of exclusive artificial feeding during the first 6 months of life Children aged 2 to 15 years Children with a maximum of 50% of their energy intake provided by the oral route (3 or 4 patients with 0% intake, defined as an internal control) Whose parents gave consent for study participation No oral disorder children group: No oral disorder children whose parents signed an informed consent for the participation of their child to the study Exclusion Criteria: Oral disorder children group: Child refusing to participate Absence of parents consent Less than 3 months of artificial feeding during the first 6 months of life, Immunosuppressive medication that might interfere with the saliva composition, Children not covered by the social security No oral disorder children group: Child refusing to participate Absence of parents consent History of or current enteral or parenteral feeding. Children not covered by the social security No oral disorder children are matched to Oral disorder children on age and sex.
Facility Information:
Facility Name
Service de Gastroentérologie, hépatologie et nutrition Hopital Femme Mere Enfant
City
Bron
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28185876
Citation
Morzel M, Truntzer C, Neyraud E, Brignot H, Ducoroy P, Lucchi G, Canlet C, Gaillard S, Nicod F, Nicklaus S, Peretti N, Feron G. Associations between food consumption patterns and saliva composition: Specificities of eating difficulties children. Physiol Behav. 2017 May 1;173:116-123. doi: 10.1016/j.physbeh.2017.02.005. Epub 2017 Feb 6.
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