Homogeneous subgroup identification in fatigue management across chronic immune diseases through single subject research design (MyOwnResearch)

Patients with a chronic immune disease that have disease-overarching intestinal
complaints and fatigue comprise a very heterogeneous population, that GP*s find
very hard to help. Patients hence massively experiment at home with products
available in the market to remediate their complaints. This study will be
conducted to explore parameters that can define the responsiveness to self-care
interventions of specific subgroups. This information can then be further
examined in future clinical trials. In addition, we will learn if we can
empower patients to become self-researchers as a large source of useful
information for subgroup definition in order to conduct more efficient clinical
trials in such heterogeneous patient populations in the future (see for a new
social contract Vayena et al, 2016.
One of the most common burdens reported by chronic patients, and large numbers
seek remediation for, is their lack of energy (fatigue). This lack of energy,
or fatigue, is impairing optimal functioning in many domains of daily life. In
a survey of the SGF, 85% of patients considered chronic fatigue the most
relevant focus for future research. Many chronic diseases are associated with
intestinal microbial dysbiosis and impaired intestinal barrier function
resulting in a low grade systemic inflammation and intestinal complaints.
Activation of the immune system (inflammation) is identified as a key
determinant of disease-related fatigue caused by the neuro-active properties of
signal molecules (i.e. cytokines) secreted by the immune system
(gut-immune-brain axis). The immune system is a complex domain where many
*agents* interact, modulating health and disease states over time. The
correlation of the *fitness* or *health* of the immune system with other
factors, such as psychosocial and lifestyle factors, is evident but has not yet
been fully understood mechanistically.

To develop a new personalized assessment and analysis approach for identifying
efficacy of self-care interventions (home-experimentation), focusing on food
supplement use to reduce fatigue. This novel approach is designed to empower
patients in their capacity of citizen-scientists. Target group is patients with
a chronic immune disease in remission/non active state who are bothered by
fatigue- and intestinal complaints (the latter pre-selects patients with
possible intestinal dysbiosis).
The second aim is to garner in-depth knowledge on mechanisms explaining
individual response differences to self-care interventions that will be tested
by the patients (i.e., standardized probiotic formulations, personalized pre-
and probiotic formulations, food supplements) using multilayer network
analyses/machine learning in order to determine complaints (i.e., varies per
patient) and parameters that can distinguish specific defined subpopulations
for targeted RCTs.

N=1 study. The duration of MyOwnResearch is approx. 12 weeks. The study starts
with the subscription on the website. Part of the subscription is a brief
screening that must indicate whether the subject fullfills all conditions for
participation. Subjects that can participate, start with a preparatory period
of 3 weeks. Thereafter the treatment period of 8 weeks will start. The subject
will be treated with the study treatment that he/she has chosen.

1. DJ Repair. This is a mixture of glutamine, zinc and N-acetyl-L-cystein
(NAC).
2. Eight fixed mixtures of probiotics, prepared by the manufacturer to achieve
predefined effects.
3. A mixture of well-known approved substances (like DJ Repair,and various
probiotics) specially prepared for this subject. The personalized advice is
from the Microbioom Center.

Minimal risks.
Burden:
3 visits to GP
Complete questionnaires via website, weekly
Complete dairy (complaints) (app), daily.
Laboratory tests (blood 30 ml, saliva, faeces), twice.
Take a supplement (oral), daily.