MedTrace Logo

Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease

NCT06019117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-07-30

No results posted yet for this study

Summary

Evaluation of the effects of the K10 probiotic mix in patients with degenerative neurological diseases (Parkinson and Alzheimer's) with a focus on cognitive, motor and psychiatric neurological evaluation.

Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study. Two groups will be composed, with two arms each, 1 group composed of patients with Parkinson's and 1 group with patients with Alzheimer's, 52 patients in each group. The first arm of each group will receive placebo and the other arm of each group will receive the mix K10.

In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of a probiotic preparation (Probiotic K10) to evaluate its use as a viable treatment option for neurodegenerative disorders, including Parkinson's disease (PD) and Alzheimer's disease. of Alzheimer (AD). This formulation has been previously demonstrated to improve cognitive function, systemic inflammation, systemic oxidative stress in Alzheimer's patients. The main objective of this study is to compare its effect with placebo on cognitive status in individuals with AD and PD, the UPDRS total score in people with early PD and quality of life, and the measurement of caregiver burden in AD and PD. Participants will be randomly assigned to receive a placebo (an inactive substance) and a K10 probiotic (dose 30.000.000 CFU/day). They will be evaluated at baseline, 45 days and 90 days.

Conditions

  • Parkinson Disease
  • Alzheimer Disease

Interventions

DIETARY_SUPPLEMENT

Probiotic K10

clinical trial using 90 days of probiotic K10

DRUG

Placebo

clinical trial using 90 days of placebo controlled

Sponsors & Collaborators

  • Deivis de Oliveira guimaraes

    lead NETWORK

Principal Investigators

  • Alyne M Ton, post-doc · Gon1 Gestora de Projetos

  • Sarha A L Queiroz, PhD · Gon1 Gestora de Projetos

  • Deivis O Guimaraes, Mba · Gon1 Gestora de Projetos

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2023-11-25
Completion
2024-01-07

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019117 on ClinicalTrials.gov