Syalogram in chronic fatigue syndrome

ISRCTN	ISRCTN05731670
DOI	https://doi.org/10.1186/ISRCTN05731670
Secondary identifying numbers	218/09

Submission date: 09/04/2009
Registration date: 20/04/2009
Last edited: 20/04/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Antoni Fernandez Sola
Scientific

Paseo Manuel Girona, 23
Edificio San Odon
Clinica CIMA
Barcelona
08034
Spain

Email	antoni.fernandez@cimaclinic.com

Study information

Study design	Interventional non-randomised non-controlled clinical descriptive study
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The syalogram: utility of a biochemical test for evaluation of salival alterations in chronic fatigue syndrome (CFS) and other related diseases
Study acronym	Syalogram in CFS
Study objectives	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(s)	Center for Applied Medical Research (CIMA) Clinic committee gave approval (ref: 23/2009)
Health condition(s) or problem(s) studied	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
Primary outcome measure	Concentration of Na, K, cortisol, proteins, pH.
Secondary outcome measures	Volume/minute of saliva secreted.
Overall study start date	01/05/2009
Completion date	30/08/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	50
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/05/2009
Date of final enrolment	30/08/2011

Locations

Countries of recruitment

Spain

Study participating centre

Paseo Manuel Girona, 23

Barcelona
08034
Spain

Sponsor information

Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain)
Research organisation

Paseo Manuel Girona, 23
2-planta
Barcelona
08034
Spain

Email	info@fundacionfatiga.org
Website	http://www.fundacionfatiga.org
"ROR"	https://ror.org/03p4nrj93

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan