NCT04828421

Brief Summary

This study evaluates the cognitive and emotional effects of probiotics in healthy elderly patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

March 29, 2021

Last Update Submit

May 29, 2022

Conditions

Healthy

Keywords

ProbioticsCognitiveEmotionalAgingElderly

Outcome Measures

Primary Outcomes (10)

  • Change from Baseline Anxiety at 10 weeks

    The State-Trait Anxiety Inventory. Score range: 20-80

    Before and after treatment (10 weeks)

  • Change from Baseline Depression at 10 weeks

    The Beck Depression Inventory. Score range: 0-63.

    Before and after treatment (10 weeks)

  • Change from Baseline General Cognitive Status at 10 weeks

    Mini-Mental State Examination. Score range: 0-35

    Before and after treatment (10 weeks)

  • Change from Baseline Working Memory at 10 weeks

    Digits task, Corsi task

    Before and after treatment (10 weeks)

  • Change from Baseline Planning Ability at 10 weeks

    Tower of London test

    Before and after treatment (10 weeks)

  • Change from Baseline Problem-solving ability at 10 weeks

    Wisconsin Card Sorting test

    Before and after treatment (10 weeks)

  • Change from Baseline Selective attention, cognitive flexibility and response inhibition at 10 weeks

    Stroop task

    Before and after treatment (10 weeks)

  • Change from Baseline Visual Attention at 10 weeks

    Trail Making Test

    Before and after treatment (10 weeks)

  • Change from Baseline Motor impulsivity or inhibitory response at 10 weeks

    Go/No-Go task

    Before and after treatment (10 weeks)

  • Change from Baseline Choice impulsivity or impulsive decision-making at 10 weeks

    Iowa Gambling Task

    Before and after treatment (10 weeks)

Secondary Outcomes (8)

  • Change from Baseline Food Habits at 10 weeks

    Before and after treatment (10 weeks)

  • Change from Baseline Alcohol Use at 10 weeks

    Before and after treatment (10 weeks)

  • Change from Baseline Body Composition at 10 weeks

    Before and after treatment (10 weeks)

  • Change from Baseline Physical Activity at 10 weeks

    Before and after treatment (10 weeks)

  • Change from Baseline Stool Consistency at 10 weeks

    Before and after treatment (10 weeks)

  • +3 more secondary outcomes

Study Arms (2)

Probiotic group

EXPERIMENTAL

Participants will be treated with a daily capsule of a multi-species probiotic (3.3 billion Lactobacillus rhamnosus and Bifidobacterium lactis) during 10 weeks.

Dietary Supplement: Lactobacillus rhamnosus and Bifidobacterium lactis

Placebo group

PLACEBO COMPARATOR

Participants will receive a harmless substance (potato starch) during 10 weeks.

Dietary Supplement: Placebo

Interventions

Lactobacillus rhamnosus and Bifidobacterium lactisDIETARY_SUPPLEMENT

Probiotics

Probiotic group
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be aged 55 years or over,
  • voluntarily agree to participate in the study in accordance with the Helsinki declaration,
  • not be participating in another study that could interfere with the results.

You may not qualify if:

  • suffer from any serious mental illness other than depression and anxiety,
  • score below 10 on the Mini-Mental State Examination (MMSE) (severe cognitive impairment)
  • be using medications that affect cognition,
  • taking anti-inflammatory drugs, antipsychotics, antibiotics and/or anxiolytics,
  • have a serious illness (e.g. cancer, Parkinson's or Alzheimer's).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universidad de Almeria

Almería, Almeria, 04120, Spain

Location

Universidad de Almeria

La Cañada de San Urbano, Almeria, 04120, Spain

Location

Pablo Roman

Almería, 04120, Spain

Location

Related Publications (1)

  • Ruiz-Gonzalez C, Cardona D, Rueda-Ruzafa L, Rodriguez-Arrastia M, Ropero-Padilla C, Roman P. Cognitive and Emotional Effect of a Multi-species Probiotic Containing Lactobacillus rhamnosus and Bifidobacterium lactis in Healthy Older Adults: A Double-Blind Randomized Placebo-Controlled Crossover Trial. Probiotics Antimicrob Proteins. 2025 Oct;17(5):3525-3537. doi: 10.1007/s12602-024-10315-2. Epub 2024 Jun 27.

    PMID: 38935259DERIVED

Study Officials

  • PABLO R LOPEZ

    Universidad de Almeria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Vicedean of Nursing

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 2, 2021

Study Start

July 17, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)