Probiotic formula to see if it helps mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests whether a dietary probiotic supplement can improve cognitive function in adults with mild cognitive impairment. It plans to enroll 100 participants from Madrid, randomizing them to receive either the probiotic or a placebo for a defined period. The trial will assess changes in cognitive performance using standard cognitive measures and monitor safety and tolerability. The design focuses on a nutrition-based approach to potentially delay progression toward dementia by modifying gut microbiota. Conducted under academia–industry collaboration, the study emphasizes early intervention in a real-world clinical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men and women aged between 60 and 85 years.
* Present "Mild Cognitive Impairment" (MCI) based on:
* MoCA test (\< 26 points) or score adjusted for educational level
* and CDR test (≤ 0.5 points)
* Maintain functional capacity according to the (I)ADL test (≥ 70 points)
* Show "cognitive concern" reported by the participant and/or a surrogate caregiver
* Demonstrate longitudinal decline in cognitive function (progressive and not stabilized) for more than 3-5 years.
* BMI ≥ 20 and \< 30 kg/m²
* Absence of a family or social environment that prevents treatment adherence.
* Adequate cultural level and understanding of the clinical study.
* Agree to participate voluntarily in the study and provide written informed consent.

Exclusion Criteria:

* Subjects with severe neurological or psychiatric disorders due to any of the following causes: severe dementia, depression, epilepsy, schizophrenia, or bipolar disorder.
* Subjects who have suffered a severe stroke prior to the study (FAZKAS=3)
* Subjects with a history of malignancy \< 5 years (\< 5 years if the brain was affected)
* Subjects who have experienced severe traumatic brain injury with structural brain injury and/or prior brain surgery
* Subjects with pacemakers and those with metal implants that may interfere with EEG or MRI
* Subjects treated with medications: benzodiazepines, neuroleptics, narcotics, anticonvulsants, or sedative-hypnotics in the last 3 months
* Subjects who have been treated with antibiotics or probiotic supplements at least 3 months before the start of the study.
* Subjects with hearing or visual impairments that prevent the evaluations included in the study
* Subjects with severe illnesses affecting nutritional status (liver, kidney, etc.)
* Subjects who have engaged in weight loss diets or significant dietary changes in the 8 weeks prior to starting the study
* Subjects with high alcohol consumption (\> 3 alcoholic beverages per day)

Where it's running

• Hospital Clínico San Carlos
  Madrid, Madrid, Spain Recruiting
• Facultad de Farmacia Universidad Complutense de Madrid (UCM) Plaza Ramón y Cajal
  Madrid, Madrid, Spain Not yet recruiting

Study contacts

• Study coordinator: Ana M López Sobaler
• Email: asobaler@ucm.es
• Phone: +34 913941732

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.