To characterize the interaction between the gut microbiome, related metabolites, immune function, and perceived complaints in QFS-patients, CFS-patients, and healthy individuals.
ID
Source
Brief title
Condition
- Gastrointestinal infections
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The composition of the gut microbiome (classes of colonizing microorganisms)
will be compared between patients and healthy individuals.
Secondary outcome
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.
Background summary
Q fever fatigue syndrome (QFS) is a well documented state of prolonged fatigue
following acute Q fever. Up to 20% of patients that are diagnosed with acute Q
fever will develop QFS, leading to a substantial burden for the affected
individuals. Current research mainly focuses on new methods for diagnosing and
treating QFS, while its etiology remains elusive. A possible explanation for
these persistent complaints could lie in the composition of the gut microbiome,
a contributor to health and disease that over the past few years has been found
influence different diseases. The different symbiotic microorganisms that
together form the composition of the microbiome, each exert a different effect
on their host through digestion of food, production of metabolites, alteration
in membrane permeability, and stimulation of the local immune system and
nervous system. Ultimately, the gut microbiome can influence the central
nervous system, and vice versa, possibly contributing to the neurocognitive
complaints that are often seen in QFS and chronic fatigue syndrome (CFS).
Study objective
To characterize the interaction between the gut microbiome, related
metabolites, immune function, and perceived complaints in QFS-patients,
CFS-patients, and healthy individuals.
Study design
This observational case control study will be performed at the Radboudumc,
Nijmegen. The duration of the study is 1 year. The study will recruit and
analyse 30 QFS-patients and 30 CFS-patients and compare this data with existing
data from 30 healthy individuals, derived from the 500FG study
(NL42561.091.12). We will use several approaches to answer the described
research questions:
1. Metadata will be collected from all the participants using standard
questionnaires on lifestyle. For patients, additional questionnaires on fatigue
will be collected being the Checklist Individual Strength (subscale on fatigue)
and the Sickness Impact Profile 8.
2. Microbiome analysis will be performed on faecal samples.
3. The function of the immune system and microbiome will be analysed through
analysis of circulating cytokines and metabolites in unstimulated blood
(plasma).
4. Clinical data will constitute Q-fever serology.
Study burden and risks
- No risks other than local hematoma related to a single venous puncture
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59116.091.16 |