The microbiome of Q Fever Fatigue Syndrome (QFS)

Completed

Conditions: Q fever
Q fever fatigue syndrom
10017966
10002252

Registration Number: NL-OMON43296

Lead Sponsor: Algemene Interne Geneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Healthy controls (n=30)
- Female gender
- Age between 18 and 59 years old;QFS patients (n=30)
- Female gender
- Age between 18 and 59 years old
- LCI guideline on QFS diagnosis of QFS
- Score >=40 on the subscale fatigue of the Checklist Individual Strength (CIS) at time of diagnosis
- Severe functional impairment on Sickness Impact Profile-8 (SIP-8), defined as a SIP total score >=700 at time of diagnosis
- Fatigue duration for under 10 years;CFS patients (n=30)
- Female gender
- Age between 18 and 59 years old
- CDC diagnosis of CFS
- Score >=40 on the subscale fatigue of the Checklist Individual Strength (CIS) at time of diagnosis
- Severe functional impairment on Sickness Impact Profile-8 (SIP-8), defined as a SIP total score >=700 at time of diagnosis
- Fatigue duration for under 10 years, or recent progression of symptoms

Exclusion Criteria

Healthy controls (n=30)
- No pregnancy / nursing
- No somatic or psychiatric comorbidity
- No complaints of fatigue (no complaints on lifestyle questionnaires)
- No use of medication in the last month (except oral contraceptives and / or paracetamol
- No vaccination during the last month before the study
- No substance abuse in the last 3 months before the study
- No history of Q fever, tested with serology;QFS patients (n=30)
- No pregnancy / nursing
- No somatic or psychiatric comorbidity
- No use of medication in the last month (except oral contraceptives and / or paracetamol
- No vaccination during the last month before the study
- No substance abuse in the last 3 months before the study;CFS patients (n=30)
- No pregnancy / nursing
- No somatic or pshychiatric comorbidity
- No use of chronic or acute medication during the last month before the study (except oral contraceptives and / or paracetamol
- No vaccination during the last month before the study
- No substance abuse in the last 3 months before the study
- No history of Q fever, tested with serology

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The composition of the gut microbiome (classes of colonizing microorganisms)<br /><br>will be compared between patients and healthy individuals.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The composition of circulating cytokines will be compared between cohorts<br /><br>The composition of circulating metabolites will be compared between cohorts<br /><br>The correlation of the gut microbiome (classes of colonizing microorganisms)<br /><br>with the circulating cytokines and metabolites, and perceived complaints will<br /><br>be compared within each cohort and between cohorts.</p><br>