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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01532323
First received: January 31, 2012
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Oral Disorder
Other: Taking of saliva before and after gustatory stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Oral Sphere: Salivary Markers and Food. A Prospective Study in Children Expressing Oral Disorders

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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 [ Time Frame: at enrolment, and at months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]

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. [ Time Frame: at enrolment, and at months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
  • Types of diet and eating habits questionnaire [ Time Frame: at enrolment, 6 months and 12 months after enrolment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral disorder children
Oral disorder children aged 2 to 15 years
Other: Taking of saliva before and after gustatory stimulation
Taking of saliva before and after gustatory stimulation (3 drops of citric acid 2.4 g / L)
Active Comparator: Control group
No oral disorder children aged 2 to 15 years
Other: Taking of saliva before and after gustatory stimulation
Taking of saliva before and after gustatory stimulation (3 drops of citric acid 2.4 g / L)

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01532323

Locations
France
Service de Gastroentérologie, hépatologie et nutrition Hopital Femme Mere Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01532323     History of Changes
Other Study ID Numbers: 2011.671
Study First Received: January 31, 2012
Last Updated: September 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Oral disorders

Additional relevant MeSH terms:
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 24, 2014