Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 4, 2023
Open Peer Review Period: Jul 4, 2023 - Aug 29, 2023
Date Accepted: Sep 18, 2023
(closed for review but you can still tweet)
Cognitive dysfunction and affective mood disorders screening in patients with chronic inflammatory bowel diseases (COGN-IBD-1): a prospective study protocol
ABSTRACT
Background:
Studies have been suggesting that mild cognitive impairment (MCI) and Alzheimer Dementia (AD) might be more frequent in patients diagnosed with inflammatory bowel diseases (IBD) but the relationship between these two entities was not entirely established. Certain blood markers might predict the installment of mild cognitive impairment or dementia or the progression to a further state. The gut-brain axis might be the key answer to the development of MCI within IBD patients, along systemic inflammation and adverse effects of medication.
Objective:
The aim is to investigate if the gut-brain axis has a role in the development of mild cognitve impairment in patients diagnosed with inflammatory bowel diseases.
Methods:
Presumed cognitive dysfunction blood markers are used as predictive factors for the evolution of the dysfunction. A case-control study including at least 100 patients will be conducted on patients diagnosed with IBD, matched with 100 healthy individuals controls(HC). The matching will include sex, age and education. The cases will include patients with a diagnosis of IBD who already have a biopsy that confirmed the diagnosis. Patients will be fully examined, a full interview, a neurological and cognitive examination will be performed. The primary clinical outcomes will be cognitive tests scores. A blood sample from each participant will be collected. Blood samples will be prepared and alliquotes will be immediately stored in a biobank. Primary laboratory outcomes will include serum levels of homocysteine, alpha amyloid, S100-B protein and brain-derived neurotrophic factor. Follow-up will be done at 12, 24 and 36 months.
Results:
We expect to see if there is any correlation between gut-brain axis dysfunction and the development of mild cognitive impairment.
Conclusions:
Gut-brain axis might have a key role in the development of MCI in patients with IBD. Clinical Trial: Study was registered on clinicaltrials.gov with identifier NCT05760729.
Citation
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