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Multiple n-of-1 self-investigation observational studies with patient-chosen products targeting the gut ecosystem to reduce chronic fatigue

Multiple n-of-1 self-investigation observational studies with patient-chosen products targeting the gut ecosystem to reduce chronic fatigue - MyOwnResearch (MORe)

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48285
Enrollment
500
Registered
2019-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

chronische ziekten met vermoeidheid en darmklachten chronic diseases

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients are diagnosed with chronic (immune) disorder; a chronic immune disease should be currently in remission/non active as determined by the GP (or medical specialist). 2. Report significant fatigue (score >

Exclusion criteria

Exclusion criteria: 1. Changes of medication or diet in the previous 3 months or during the course of the study, e.g., attending a weight loss program or changing to a vegetarian or vegan diet, or initiating new food supplements (including pro or prebiotics). 2. Current exacerbation of their chronic immune disease. 3. Excessive alcohol intake, defined as drinking more than 21 glasses of alcohol per week. 4. History of drug abuse or addiction. 5. Antibiotic use 6 months prior to the study. 6. Age below 18 or above 70 years. The upper limit of age is chosen since it is known that de immune system changes drastically above this age and this might affect the results of the study. 7. Pregnancy. 8. No access to internet and/or not using an iPhone or Android phone.

Design outcomes

Primary

MeasureTime frame
This observational study will generate knowledge on the individual and across-subjects effectiveness of self-chosen products targeting the gut ecosystem on chronic fatigue. In addition, it will gather valuable data that can be analyzed further to test and generate new hypotheses on biological mechanisms in chronic fatigue (e.g., gut microbiota, barrier and immunological function).

Secondary

MeasureTime frame
The study will also collect data (via EMA diaries) about complaints that the patient determines individually (eg about sleepiness, mood, etc.).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)