Open Clinical analyses of immunological and metabolic factors in ME/CFS (MIRACLE), 2028, Dejaco & Schieffer

Chandelier

Chandelier

Senior Member (Voting Rights)
From https://mrr.mecfs-research.org/en/mrr/researchnetworks/b9JMOZIuSGauBSS7vOuEbg

Clinical analyses of immunological and metabolic factors in ME/CFS (MIRACLE)

About

Country: Germany

Sponsors: Federal Ministry of Research, Technology and Space (BMFTR)

Research types: Basic research

www.gesundheitsforschung-bmbf.de

MIRACLE - Klinische Analysen von immunologischen und metabolischen Faktoren bei ME/CFS - BMFTR Gesundheitsforschung

www.gesundheitsforschung-bmbf.de www.gesundheitsforschung-bmbf.de

Description

ME/CFS is a complex and highly debilitating disease for which there is currently no proven therapy. The options for clinical treatment of patients are currently limited. There are large gaps in knowledge, as hardly any tissue samples from those affected are available and comparisons with defined control groups are difficult to achieve.

The MIRACLE research network aims to investigate immunological, inflammatory and metabolic signaling pathways in ME/CFS. After recruitment using web-based questionnaires and online video consultations, which are also intended to include seriously ill patients, various aspects of the signaling pathways will be investigated in more detail. Various processes of high-density lipoprotein (HDL) and the role of granulocytes in ME/CFS patients will be investigated. A comprehensive analysis of the collected data will be carried out using artificial intelligence (AI) and modern statistical methods to search for patterns for biomarkers and patient clusters in the complex data sets.

The long-term goal of this study is to uncover the causes of the disease ME/CFS and to identify clusters and biomarkers that can be used to diagnose and treat ME/CFS.

Description adapted from research network website: see link above.


Research projects​


Clinic and granulocytes​


Project status: Ongoing

Country: Germany

Principal investigator: Alexander Dejaco

Organisations: University Clinic Regensburg

Research period: 2024-11 to 2027-11

Research types: Basic research

Research areas: Immune system dysfunction, Cardiovascular system dysfunction, General


Clinic, HDL proteome, and AI​


Project status: Ongoing

Country: Germany

Principal investigator: Elisabeth Schieffer

Organisations: University Clinic Giessen and Marburg

Research period: 2024-11 to 2027-11

Research types: Basic research

Research areas: Immune system dysfunction​


From https://www.ukgm.de/ugm_2/deu/umr_kar/65384.html
Machine translation:
Miracle – ME/CFS Study

The MIRACLE research project investigates immunological, inflammatory and metabolic signaling pathways in ME/CFS. The collaboration between University Hospital Marburg (UKGM) and University Hospital Regensburg (UKR) will study a total of 200 patients with ME/CFS and 200 healthy control participants. Initial data collection and recruitment will take place via a web-based questionnaire and an online video consultation.

Patients with very severe ME/CFS who are unable to attend an outpatient appointment will initially be offered an online appointment and, if possible, will be visited at home so that this patient group, which has rarely been included in studies to date, can also take part. A comprehensive data analysis will be carried out using artificial intelligence and modern statistical methods to search the complex datasets for patterns in biomarkers and patient clusters. At the Department of Anesthesiology at University Hospital Regensburg, detailed analyses will be conducted to determine the inflammatory profile of neutrophil granulocytes, a critical part of the immune defense system.

This includes analyzing the behavior of neutrophil granulocytes, such as their migration, production of reactive oxygen species, DNA network formation and release of lytic proteins. The Department of Cardiology, Angiology and Intensive Care Medicine at University Hospital Marburg will examine the proteome of high-density lipoprotein (HDL), which, as part of reverse cholesterol transport, provides insights into cellular and metabolic processes. In addition, cultured endothelial cells will be stimulated with HDL-associated proteins to investigate their inflammatory potential.

The long-term goal of this study is to uncover the causes of ME/CFS and identify clusters and biomarkers that can be used to diagnose and treat ME/CFS.

You can watch Dr. Elisabeth Schieffer’s presentation of the project at the “ME/CFS Symposium 2025 – Research and Care Studies in Germany,” held in Berlin in May, here: Elisabeth Schieffer | ME/CFS Symposium 2025: BMBF Research Consortium – MIRACLE


You can watch Dr. Elisabeth Schieffer’s presentation to the Hessian State Parliament at the symposium on post-infectious diseases / ME/CFS here: Symposium on ME/CFS and Long COVID – 6th talk: Dr. Elisabeth Schieffer


The following document contains further information for patients as well as a link to a questionnaire that you can use to take part in the study: Patient Information

If you have any questions or other concerns, please contact us at the email address below.

The Miracle Study Team

Miracle.mr@uk-gm.de



We are also looking for healthy volunteers!

We are currently looking for healthy volunteers (m/f/d) who are willing to complete several online questionnaires (taking approximately 30 minutes) and attend an in-person appointment at University Hospital Marburg for a brief physical examination, a handgrip strength test, a standing test and a blood draw. The in-person appointment will take approximately one and a half hours in total. Due to laboratory procedures, appointments are only available in the morning.

Eligibility requirements:

18–65 years old
Resident in Germany
No infections in the four weeks before the appointment
No known illnesses
No regular tobacco and/or alcohol use
No regular medication, except for:
hormonal contraceptives (“the pill”)
medication for primary prevention (taken preventively, not because of an illness)
No financial compensation is provided.

If you would like to support our project as a healthy volunteer and meet the requirements listed above, or if you have any questions, please contact the study team at: Email: Miracle.mr@uk-gm.de
 
Chandelier said:
You can watch Dr. Elisabeth Schieffer’s presentation to the Hessian State Parliament at the symposium on post-infectious diseases / ME/CFS here: Symposium on ME/CFS and Long COVID – 6th talk: Dr. Elisabeth Schieffer
Click to expand...

Sympathetic 8 min talk by Elisabeth Schieffer.
They managed to include severe and very severe patients into their cohort.
Short excerpt:

One issue that is very rarely discussed, but that I see again and again through the online consultation—and find deeply distressing—is that some patients, or indeed a significant proportion, have problems with nutrition. In our study, that was 12%. That’s not a small number.​
​
They have certain food intolerances, but also pain. Some live alone and can’t cook or shop for themselves, and some can’t eat without assistance. Their fatigue and symptoms are so severe that they’re simply unable to do so. And 0.35%—four patients in our cohort—need artificial nutrition, a special feeding tube or a port system. They exist too, and we haven’t even begun to account for them.​


Machine translated subtitles:
Thank you.

Thank you for the introduction.

Exactly. And the work with the foundation—with the online consultation—was already underway before I eventually began working in research. People approached me because I had also been involved in research in the post-COVID field, and they said, “We need expertise, and there isn’t any. There are patients lying at home, and after 30 years in medicine, I had never encountered this.” I said, “Then we need to do something about it.”

Then the director of the foundation came to me and said, “Yes, we’ve already tried to get other doctors involved.” So I said, “Okay, let’s give it a try and see how it goes.”

Unfortunately, I’ve now been doing this for three years. It was only supposed to be a temporary solution to get some care in place to begin with. But because we still don’t have established structures, I’m continuing. After three years, I’ve gained quite a lot of experience with the most severely affected patients, and I can certainly bring that experience to bear.

But for now, this is about ME/CFS in general.

As has already been mentioned, the figures vary within a certain range, because some people are more mildly affected and others more severely. But there aren’t just a few thousand people affected; there are thousands.

Our Miracle study is funded by the BMBF, with 2.4 million euros for Marburg and Regensburg together, and we are investigating the causes. We have excellent partners in basic science laboratories. As part of this study, however, we first conducted an online survey to reach out to patients and find out who is affected. I’d like to present some of the results from that initial online survey.

The figures we’re presenting here are based on 1,140 people who meet the ME/CFS criteria and for whom we have a complete set of data. Of these, 81% are women. The typical age is 47—really the prime of life—but 85% are unable to work, most of them because of this illness. In this cohort, 35% have a Bell score indicating that they are housebound or bedbound. So we’ve actually managed to reach the most severely affected people for this study as well.

Forty-five percent have a care level. These are people who were previously healthy, with an average age of 47. Women in particular have a care level. I think this post I’ve included here illustrates what that means:

“My partner is turning 50 today. I wouldn’t be here without him. When I became ill in 2023 and was completely bedbound by December of that year, he reduced his working hours to 50% to care for me. He can now work 80% again, but also takes care of the entire household, all my dealings with the authorities and paperwork…”

And further down:

“I never imagined that, in my early 40s, I would become so dependent on someone else.”

That reflects exactly what these figures show when we asked about care levels: there is a huge need, and we have to address it.

Here are a few more results from the study, because I think they reveal a great deal that we also need to incorporate into the development of these plans.

Who makes the diagnosis? In our cohort, 79% were diagnosed by hospitals and specialists, and only 21% by GPs. That’s typical: GPs are unsure and don’t know the illness. We can’t say that we should build our services around GPs at this point. That won’t work right now.

On average, 95% of the most severely affected patients have access to a GP. Eight percent are effectively without care from a GP. We asked whether their GP knows about ME. Of course, only a small proportion do. In 25% of cases, the GP is making an effort to understand ME/CFS. Yes, that willingness is clearly improving. Home visits are made in an average of 12% of cases. Among the most severely affected, 20% said their GP prescribes off-label medication. That, too, is a fairly small proportion. So we really do have a huge care problem.

The typical symptoms and the reasons these patients are so difficult to care for have already been discussed. In particular, sensitivity to light, noise and touch is something we don’t usually have to take into account when caring for someone in hospital. But with these patients, we do—otherwise their condition can worsen.

One issue that is very rarely discussed, but that I see again and again through the online consultation—and find deeply distressing—is that some patients, or indeed a significant proportion, have problems with nutrition. In our study, that was 12%. That’s not a small number. They have certain food intolerances, but also pain. Some live alone and can’t cook or shop for themselves, and some can’t eat without assistance. Their fatigue and symptoms are so severe that they’re simply unable to do so. And 0.35%—four patients in our cohort—need artificial nutrition, a special feeding tube or a port system. They exist too, and we haven’t even begun to account for them.

So how should we think about care for adults? I was impressed by PATNET: ten people in the local area involved in it. Unfortunately, we don’t have that in Marburg yet. We’ve started the study and are trying to think through how care should be organized, but we face certain limitations.

There is hardly any outpatient care for ME/CFS. You’ve heard that there is practically nothing available for patients in hospital in Germany. We don’t have a ward where we can care for these patients.

The studies that have begun are excellent. And our study? We’re making progress. We’re doing a lot, but our funding runs out next year. If we can’t secure an extension for the expertise we’ve built up—including the doctor who is now working with us—then that will be it. We’ll be back to square one.

So there’s real pressure right now. We don’t just need to maintain what we have; we need to expand it. We need social medicine specialists involved, support, and a whole network that we can bring in.

What could the goal look like? We need outpatient specialist centres with the necessary expertise, affiliated with universities. That would also allow studies to run alongside the care. We now need to work out conceptually how care can be organized, both on an outpatient basis and in hospital—and perhaps through a model ward. This is a major challenge, but we need to get started.

I believe every patient has the right to care adapted to their needs. That’s where we need to get to. The need for action is urgent.

And with that, thank you for your attention.
Click to expand...
 
Appreciate very much this kind of effort. Thank you.

It is a good sign that the message is getting through to the medical scientific community, and I hope it works out for all involved.

But I do have to ask all researchers to please not use cute acronyms, particularly ones with some kind of message embedded in them. I understand that you need a short clear title, no problem with that. But please avoid this kind of stuff and stick to something that is just a basic description of the study or an otherwise neutral term/title.

If you really want to give us hope then by far the best way is to do competent honest science and clinical practice based on it, and talk about it in public.
 
You must log in or register to reply here.
Back
Top Bottom