Skip to content

Investigating potential biomarkers in Myalgic Encephalomyelitis Chronic Fatigue Syndrome (MECFS) patients

Cytokine (proinflammatory/anti-inflammatory) analysis in Myalgic Encephalomyelitis Chronic Fatigue Syndrome (MECFS) patients: A Two Phase Design. Assessing differences in cytokine levels across two time points.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620001150932
Acronym
MECFS2PD
Enrollment
60
Registered
2020-11-03
Start date
2020-11-23
Completion date
2022-03-01
Last updated
2020-11-09

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

Conditions

None listed

Brief summary

The aim of the project is to examine the underlying biology of 40 people who have been diagnosed with ME/CFS (Myalgic encephalomyelitis / Chronic Fatigue Syndrome) by their general practitioner comparing these symptoms to people who are well (controls) . We have brought together a team of clinicians and researchers to investigate ME/CFS from a multidisciplinary perspective. The diagnosis will be confirmed using the Canadian Consensus ME/CFS definition, interviews and questionnaires. We will aim to take blood samples, urine and faecal samples at times when the sufferer is experiencing what is often referred to as a ‘crash’ (a period of significant worsening of symptoms and accompanying greater impairment). Another set of samples will be taken when the person is feeling relatively well. A series of questionnaires will be used to obtain information about symptoms and experiences. We will examine the differences in the blood, urine and faecal samples across these two times. Samples will be taken as early as possible to allow for fasting i.e. between 8am and 10am to be negotiated with participant. There are no interventions or medications involved in this research. The most invasive aspects of the research is 2 sets of blood samples (51mls occasion 1 and 36mls occasion 2) and some questionnaires. This is an observational study.

Interventions

Samples will be collected at two time-points within a 12 month period, but the time between these two points will be a minimum of 1 month, but within 12 months (determined by the experience of a subjective 'crash'. The baseline assessment will require a series blood samples which requires approximately 55 ml for baseline and the cytokine assessment. Any unused portion of these samples will be stored for future research studies. The second occasion will require less blood to compare with the fi

Samples will be collected at two time-points within a 12 month period, but the time between these two points will be a minimum of 1 month, but within 12 months (determined by the experience of a subjective 'crash'. The baseline assessment will require a series blood samples which requires approximately 55 ml for baseline and the cytokine assessment. Any unused portion of these samples will be stored for future research studies. The second occasion will require less blood to compare with the first (36 ml). Blood samples will be collected by a nurse who will also administer the questionnaires. Some questionnaires can be completed online (taking approximately 1 hour). Each study visit is expected to take approximately 1 hour. The following three questionnaires will be used as part of the interview: Hamilton Depression Scale, Hamilton Anxiety Scale and the General Physical Activity Questionnaire (administered by the nurse interviewer) measured during the visit. Becks Depression Inventory, Flinders Sleep Questionnaire which are self administered will be completed by the participant within a week of the blood test. Then other self completion questionnaires include the DePaul Symptom Questionnaire (DSQ-2), Revised Fibromyalgia Impact Questionnaire, Chronic Fatigue & Fibromyalgia Symptom checklist. We will also ask for a list of Current Medications, and List of Current Supplements. Additionally, we will take bio-metric measures such as your weight, height, blood pressure, and waist hip ratio. Timing: All samples will be taken in a condition of fasting from midnight the night before, and collected between 8am and 10am to suit participant. The questionnaires will be completed at both time points described earlier (when subjectively well, and during a subjective crash). The sleep monitoring will only occur once only as part of the baseline assessment. A crash will be a subjective experience expressed by the participant whereby they feel significantly worse than their usual level of functioning. There is no subset of participants. All participants will be asked to undergo a sleep monitoring test which involves wearing a monitor overnight. This will be a singular assessment as part of the baseline within a week of the initial samples and are an optional part of the research, which we anticipate most participants will be interested in completing. Symptom data collected on the app will be a simple list of common MECFS symptoms described in the International Consensus Criterion. The length of time the app is used for is an optional type of monitoring of symptoms, but for no longer than the period of involvement in the study, i.e. maximum 12 months. Symptoms to monitor will be selected by participants i.e. anything between 5 and 21 common symptoms such as fatigue, headaches, and pain levels. A stool sample and a urine sample will be requested to collect as part of our of collection for future research. This is optional.

Sponsors

South Australian Health & Medical Research Institute
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Participants will have a diagnosis of ME/CFS. They will be based in South Australia unless special arrangements can be organised to collect bloods interstate. A formal diagnosis of ME/CFS will have been made by a general practitioner or medical specialist. They will also consent for their GP to be provided with information if required for example feedback about clinical levels of moderate to severe depression. Healthy participants will be those who do not have other current physical health or mental health problems. They will also consent for their GP to be provided with information if required for example feedback about clinical levels of moderate to severe depression.

Exclusion criteria

Exclusion criterion includes hormonal disorders, major physical or mental health disorders, or outside of the age range. Exclusion criteria include pregnancy, other diseases requiring medication that may affect the results, alcohol or substance abuse or dependence. Other physical disorders that may confound the measurements listed earlier, such as anaemia, or a thyroid disorder. Any mental health disorder that requires medication, psychosis, affective disorders. Low dosages of antidepressant for the purpose of sleep will be accepted. Being unable to understand the consent process due to language or an inability to read English. Must be at least 18 years of age, and up to 65 years. Morbid Obesity will be an exclusion factor i.e. must have a BMI <40 (35 equates to the WHO obesity type ii and 40 morbidly obese).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026