Condition category
Musculoskeletal Diseases
Date applied
09/04/2009
Date assigned
20/04/2009
Last edited
20/04/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.institutferran.org/investigacion.htm

Contact information

Type

Scientific

Primary contact

Dr Antoni Fernandez Sola

ORCID ID

Contact details

Paseo Manuel Girona
23
Edificio San Odon
Clinica CIMA
Barcelona
08034
Spain
antoni.fernandez@cimaclinic.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

218/09

Study information

Scientific title

The syalogram: utility of a biochemical test for evaluation of salival alterations in chronic fatigue syndrome (CFS) and other related diseases

Acronym

Syalogram in CFS

Study hypothesis

In chronic fatigue syndrome (CFS) salivary disorders are common. Xerostomia, burning mouth, gingivitis and mucosal ulcers are clinical presentations of salivary disorders.

Hypothesis:
We have developed an easy biochemical salivary test to determine pH, sodium (Na), potassium (K), proteins and cortisol concentrations, and the volume/minute of salivary secretion: the syalogram. We want to standardise it as a reliable method of testing salivary function. We want to find the alterations of the salivary function in patients with chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME), fibromyalgia (FM), Sjögren's syndrome and other related diseases.

Ethics approval

Center for Applied Medical Research (CIMA) Clinic committee gave approval (ref: 23/2009)

Study design

Interventional non-randomised non-controlled clinical descriptive study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic fatigue syndrome/fibromyalgia/Sjögren's syndrome

Intervention

Collection of one sample of saliva for biochemical test and one sample for volume/minute determination. There is no follow-up and the duration of each test is under one minute.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Concentration of Na, K, cortisol, proteins, pH.

Secondary outcome measures

Volume/minute of saliva secreted.

Overall trial start date

01/05/2009

Overall trial end date

30/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic fatigue syndrome (CFS), fibromyalgia (FM), Sjögren's syndrome or sicca syndrome
2. One of the following symptoms: xerostomia, burning mouth, mucosal ulcers
3. No age range, either sex

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

50

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/05/2009

Recruitment end date

30/08/2011

Locations

Countries of recruitment

Spain

Trial participating centre

Paseo Manuel Girona, 23
Barcelona
08034
Spain

Sponsor information

Organisation

Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain)

Sponsor details

Paseo Manuel Girona
23
2-planta
Barcelona
08034
Spain
info@fundacionfatiga.org

Sponsor type

Research organisation

Website

http://www.fundacionfatiga.org

Funders

Funder type

Research organisation

Funder name

Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes