Design of Personalised SupplemenTs Based on the Gut MicRobiota Through Artificial Intelligence for Alzheimer's Patients

Launched by UNIVERSIDAD COMPLUTENSE DE MADRID · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how changes to the gut microbiota—tiny organisms living in our intestines—might help people with Alzheimer’s disease. Researchers believe that a healthier diet could positively impact these gut bacteria and, in turn, help slow down the symptoms of Alzheimer’s. The study will look at how personalized dietary supplements, designed with the help of artificial intelligence, can influence gut health and possibly improve outcomes for patients with Alzheimer’s.

To participate in the trial, individuals must be able to understand the study and provide written consent, have a caregiver who can help with daily activities and attend study visits, and meet specific criteria for early-stage Alzheimer’s disease. Participants will have regular check-ins with the research team to monitor their progress. It’s important to note that people with certain health issues, particularly those affecting the brain or gut, may not be eligible for this study. Overall, this trial aims to discover new ways to support Alzheimer’s patients through diet, which could lead to better management of this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. to be able to give written consent signed jointly by the patient's legal representative following the rules of the clinical research ethics committee
• • 2. minimum educational level (reading and writing)
• • 3. proficiency of the language of the tests applied; adequate visual and auditory acuity, in the opinion of the researcher, to enable him/her to carry out the tests in the study (compensatory glasses and hearing aids are allowed
• • 4. compliance with the diagnostic criteria of prodromal Alzheimer's Disease according to the criteria of the Institute on Aging- Alzheimer's Association \[NIA-AA\]: Global Deterioration Scale GDS≥ 2-3
• • 5. Availability of a person ('caregiver') who has frequent and sufficient contact with the subject, so that he/she can provide precise information on the subject's day-to-day life, and attend the visits that are required by the study
• Exclusion Criteria:
• • 1. Suffer or have suffered from neurological (epilepsy, sleep disorders, etc.), psychiatric or any other type of pathology (sensory, hepatic, infectious, etc.) which, in the investigator's opinion, may affect their current cognition and functionality
• • 2. Metabolic/endocrine disorders: Type I diabetes, the rest will not be excluded
• • 3. Chronic or sporadic use of antibiotics, antifungals, antivirals or anti-parasitic agents and chronic use of proton pump inhibitors (omeprazole, etc.). The chronic medication that these patients take due to hypertension, diabetes, etc., should be recorded in the database but should not be a criterion for exclusion
• • 4. Suffer from some type of pathology related to the gastrointestinal system or have undergone gastrointestinal surgery (ulcerative colitis, Crohn's disease, bariatric surgery)
• • 5. Pre-menopause or perimenopause
• • Control patients: recruited among the relatives and companions of the patients and/or in primary care centers in the region of Murcia. The inclusion criteria for the control group will be the same as for the Alzheimer's group except for the requirements regarding cognitive impairment. The intention is for the control group to be similar in age and sex distribution to the Alzheimer's group.