Probiotics in Dementia

NCT03847714 | Completed

• 1 other identifier: PIDE
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia is associated with changes in gut microbiome composition, gut barrier dysfunction, intestinal inflammation and systemic inflammation. Probiotics are a possibility to modulate the gut-brain axis. In this study the effect of probiotics on the gut microbiome and, gut barrier function, inflammation and cognitive dysfunction will be studied.

Conditions

Dementia; Alzheimer, Mixed Type (Etiology)

Outcome Measures

Primary Outcomes (1)

• Butyrate producing bacteria

  abundance of butyrate producing bacteria

  6 months

Secondary Outcomes (25)

• Butyrate producing bacteria

  12 months

• diaminooxidase concentration in serum

  6 months

• diaminooxidase concentration in serum

  12 months

• zonulin concentration in stool

  6 months

• zonulin concentration in stool

  12 months

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Bifidobacterium bifidum W23, B. lactis W51, B. lactis W52, Lactobacillus acidophilus W22, L. casei W56, L. paracasei W20, L. plantarum W62, L. salivarius W24, Lactococcus lactis W19, 7.5 × 109 Colony Forming Units/g twice daily dissolved in water

Dietary Supplement: Omni-Biotic Stress Repair

Placebo

PLACEBO COMPARATOR

3g of a similar looking and tasting powder, twice daily

Dietary Supplement: placebo

Interventions

Omni-Biotic Stress Repair DIETARY_SUPPLEMENT

The probiotic supplement is a commercially available food for special medical purposes and includes 9 bacterial strains with at least 7.5 billion organisms (7.5 × 109 Colony Forming Units/g) per 1 portion (= 3 g).

Also known as: Omni-Biotic SR-9, Winclove 825

Probiotic

placebo DIETARY_SUPPLEMENT

similar looking and tasting powder

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Dementia of Alzheimer type and mixed type (diagnosis by a board-certified neurologist/psychiatrist and according to ICD10)
• Mini Mental State Examination 21-26
• Stable treatment with anti-dementia drugs including phytotherapeutics (\>3 months) or no intention to start anti-dementia drugs
• Informed consent

You may not qualify if:

• Other forms of dementia
• Inflammatory bowel diseases
• Liver cirrhosis
• Antibiotic treatment within the last 4 weeks
• Febrile illness within the last 4 weeks
• Acute hospital admission for dementia-unrelated reasons within the last 4 weeks
• Dysphagia
• Any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Austria

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: similar looking and tasting placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 20, 2019
• Study Start: June 15, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: at time of publication; no limit
• Access Criteria: open

Locations

AU (1)