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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48216
Enrollment
500
Registered
2019-05-21
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 immuunziekten met vermoeidheids- en darmklachten chronic immune diseases

Interventions

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 w

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years and above 2. Chronic immune disease, currently in remission/non-active 3. Significant fatigue, as measured by the Short Fatigue questionnaire 4. Persistent intestinal complaints, as measured by the IBS-SSS

Exclusion criteria

Exclusion criteria: 1. Changes of medication or diet in the previous 3 months or during the course of the study 2. Current exacerbation of chronic immune disease; 3. Excessive alcohol intake 4. History of drug abuse 5. Antibiotic use within 6 months prior to the study start 6. Pregnancy

Design outcomes

Primary

MeasureTime frame
Patient partly self-selected end points (up to 5) which they will choose to score on a daily basis in an app. Also symptoms of fatigue and gastro-intestinal complaints will be measured by validated questionnaires, respectively the Verkorte Vermoeidheidsvragenlijst (VVV, abbreviated fatigue questionnaire), CIS20, IBS-SSS and GI-symptoms questionnaire. Primarily for diagnoses and treatment reasons blood, saliva and fecal samples will be collected both at the start and after intervention, which will be also used for further mechanistic research. We will study if there are shifts in the microbiota composition and changes in inflammatory cytokine levels that will provide us with possible (non) responder- specific biomarker profiles.

Secondary

MeasureTime frame
See primary endpoints.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)