Syalogram in chronic fatigue syndrome
| ISRCTN | ISRCTN05731670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05731670 |
| Protocol serial number | 218/09 |
| Sponsor | Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain) |
| Funder | Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain) |
- 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
Contact information
Dr Antoni Fernandez Sola
Scientific
Scientific
Paseo Manuel Girona, 23
Edificio San Odon
Clinica CIMA
Barcelona
08034
Spain
| antoni.fernandez@cimaclinic.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomised non-controlled clinical descriptive study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant 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(s) | Concentration of Na, K, cortisol, proteins, pH. |
| Key secondary outcome measure(s) | Volume/minute of saliva secreted. |
| Completion date | 30/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 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
08034
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
