Probiotic Intervention on Gut Microbiota and Cognitive Functioning in Older Adults With a Mild Cognitive Impairment
NCT05859230, Not applicable, Unknown, National University of Singapore
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Probiotic Intervention on Gut Microbiota and Cognitive Functioning in Older Adults With a Mild Cognitive Impairment | ClinicalTrials.gov |
| NCT number | NCT05859230 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National University of Singapore | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Experimental: The probiotic drink study group, Placebo Comparator: The placebo drink study group | ClinicalTrials.gov |
| First posted | 2023-05-15 | ClinicalTrials.gov |
| Last updated | 2023-05-15 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in composition of gut microbiota after probiotic and placebo intervention | Baseline, 6 weeks, 12 weeks of intervention and 6 weeks follow-up | Changes in gut microbiota composition in their abundances using 16s rRNA DNA sequencing method before the intervention, at 6 weeks and 12 weeks after the intervention and at 6 weeks follow-up will be analyzed. | ClinicalTrials.gov |
| Secondary | Changes in verbal learning and memory function of neurocognitive assessment after probiotic and placebo intervention | Baseline, 12 weeks of intervention and 6 weeks follow-up | Changes in learning and memory function of the neurocognitive tests before the intervention, at 12 weeks after the intervention, and at 6 weeks follow-up will be analyzed. The assessment of the function includes Rey's auditory verbal learning test (RAVLT) which measures immediate and delayed memory and recognition memory. The individual raw numbers of correctly recalled and recognized (0-15) will be analyzed and compared. | ClinicalTrials.gov |
| Secondary | Changes in attention and verbal working memory function of neurocognitive assessment after probiotic and placebo intervention | Baseline, 12 weeks of intervention and 6 weeks follow-up | Changes in attention and verbal working memory function of neurocognitive tests before the intervention, at 12 weeks after the intervention, and at 6 weeks follow-up will be analyzed. The assessment of the function includes the Digit Span task. The individual raw numbers of scores (0-16) will be analyzed and compared. | ClinicalTrials.gov |
| Secondary | Changes in sustained attention and reasoning function by color trails neurocognitive assessment after probiotic and placebo intervention | Baseline, 12 weeks of intervention and 6 weeks follow-up | Changes in attention and reasoning function of neurocognitive tests before the intervention, at 12 weeks after the intervention, and at 6 weeks follow-up will be analyzed. The assessment of the function includes the Color Trails test. The individual time taken in seconds will be analyzed and compared. | ClinicalTrials.gov |
| Secondary | Changes in sustained attention and reasoning function by Stroop test of neurocognitive assessment after probiotic and placebo intervention | Baseline, 12 weeks of intervention and 6 weeks follow-up | Changes in attention and reasoning function of neurocognitive tests before the intervention, at 12 weeks after the intervention, and at 6 weeks follow-up will be analyzed. The assessment of the function includes the Stroop test. The individual time taken in seconds will be analyzed and compared. | ClinicalTrials.gov |
| Secondary | Changes in language, lexical knowledge and semantic memory function of neurocognitive assessment after probiotic and placebo intervention | Baseline, 12 weeks of intervention and 6 weeks follow-up | Changes in language and semantic memory function of neurocognitive tests before the intervention, at 12 weeks after the intervention, and at 6 weeks follow-up will be analyzed. The assessment of the function includes semantic verbal fluency (animals) tests. The individual raw numbers of animals correctly named (0-40) will be analyzed and compared. | ClinicalTrials.gov |
| Secondary | Changes in visuospatial, organizational non-verbal processing function of neurocognitive assessment after probiotic and placebo intervention | Baseline, 12 weeks of intervention and 6 weeks follow-up | Changes in visuospatial, organizational non-verbal processing function of the neurocognitive test before the intervention, at 12 weeks after the intervention, and at 6 weeks follow-up will be analyzed. The assessment of the function includes total Block design scores. The individual raw numbers of scores (eg. 0-68) will be analyzed and compared. | ClinicalTrials.gov |
| Secondary | Changes in plasma immune and inflammatory markers after probiotic and placebo intervention | Baseline, 6 weeks, 12 weeks of intervention and 6 weeks follow-up | The plasma immune and inflammatory markers such as 45 plasma cytokines/chemokines levels (pg/ml) panel will be measured using the proximity extension assay (PEA) before the intervention, at 6 and 12 weeks after the intervention, and at 6 weeks follow-up. | ClinicalTrials.gov |
| Secondary | Changes in blood immune and inflammatory markers in-vitro stimulation by toll-like receptors agonists after probiotic and placebo intervention | Baseline, 6 weeks, 12 weeks of intervention and 6 weeks follow-up | Whole blood will be stimulated with toll-like receptors 2 and 4 agonists after the collection of blood. The cytokines IL-1 beta, IL-6, IL-10, IL-8 and TNF-alpha will be analyzed using the Enzyme-linked immunosorbent assay (ELISA) method and reported their levels in pg/ml. | ClinicalTrials.gov |
| Secondary | Changes in blood cortisol levels after probiotic and placebo intervention | Baseline, 6 weeks, 12 weeks of intervention and 6 weeks follow-up | The blood cortisol levels (nmol/L) will be measured using an Electrochemiluminescence immunoassay before the intervention, at 6 and 12 weeks after the intervention, and at 6 weeks follow-up. | ClinicalTrials.gov |
| Secondary | Changes in fecal short-chain fatty acids after probiotic and placebo intervention | Baseline, 6 weeks, 12 weeks of intervention and 6 weeks follow-up | The fecal short-chain fatty acids (uM/g of feces) will be measured using a Gas chromatography-triple quadrupole mass spectrometer (GC-MS) in fecal supernatants at baseline, at 6 and 12 weeks after the intervention, and at 6 weeks follow-up. | ClinicalTrials.gov |
| Other | Differences in frequency of consumption of diets between probiotic and placebo intervention groups at baseline | Baseline | Dietary questionnaires will be recorded at baseline before the intervention. The frequency of consumption of diets per day in terms of carbohydrates, proteins, vegetables, fruits, fermented foods and dairy, nuts, fast foods, beverages, desserts, and local snacks will be analyzed in two intervention groups. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)