Cytokine inhibition in Chronic Fatigue Syndrome patients - a pilot study

Phase 3

Completed

Conditions: chronisch vermoeidheidssyndroom
chronic fatigue syndrome
myalgic encephalomyelitis
10027665

Registration Number: NL-OMON40232

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

•CDC-diagnosed CFS-patients
•female, between 18 and 59 years old
•fatigue duration <=10 years, or significant increase of complaints during the last 10 years
•CIS (Checklist Individual Strength) >= 40
•marked functional impairment: Sickness Impact Profile (SIP-8) >= 700

Exclusion Criteria

•pregnant or nursing women
•women who intent to get pregnant during the study
•fatigue duration >10 years
•patients who use or have used psychotropic medication in the past month
•substance abuse in the past 3 months
•patients taking any medication except oral contraceptives and/or paracetamol
•patients with evident somatic co-morbidity
•previous or current engagement in CFS research
•inability to understand the nature and the extent of the trial and the procedure required
•psychiatric co-morbidity (major depression, psychosis, eating disorders, anxiety disorders, bipolar disease and post traumatic stress disorder) assessed with the MINI
•live vaccination during the past four weeks
•current engagement in a legal procedure

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be fatigue severity measured with the<br /><br>Checklist Individual Strength (CIS).<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures will be:<br /><br>• level of functional impairment measured with the Sickness Impact Profile<br /><br>(SIP8) total score;<br /><br>• physical and social functioning assesses with the subscale physical<br /><br>functioning and social functioning of the SF-36;<br /><br>• level of psychological distress assessed with the total score on the Symptom<br /><br>Checklist-90 (SCL-90);<br /><br>• pain severity assessed with a Visual Analog Scale (VAS);<br /><br>• cytokine measurement in blood (plasma and blood in Pax-gene tubes) and<br /><br>salivary (at protein and mRNA level);<br /><br>• cortisol measurement in salivary and hair;<br /><br>• microbiome determination in faeces;<br /><br>• body temperature and pulse rate.</p><br>