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The microbiome of Q Fever Fatigue Syndrome (QFS)

The microbiome of Q Fever Fatigue Syndrome (QFS) - Microbiome of QFS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43296
Enrollment
90
Registered
2016-11-28
Start date
2017-02-21
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q fever Q fever fatigue syndrom

Interventions

Microbiome
Q fever
Q fever fatigue syndrome

Sponsors

Algemene Interne Geneeskunde
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The composition of the gut microbiome (classes of colonizing microorganisms) will be compared between patients and healthy individuals.

Secondary

MeasureTime frame
The composition of circulating cytokines will be compared between cohorts The composition of circulating metabolites will be compared between cohorts The correlation of the gut microbiome (classes of colonizing microorganisms) with the circulating cytokines and metabolites, and perceived complaints will be compared within each cohort and between cohorts.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)