NCT05477732

Brief Summary

Stroke is a syndrome of acute, focal neurological deficit attributed to vascular injury of the central nervous system. It was the 2nd leading cause of death worldwide and accompanied by high disability rate also increases the social burden.Our research is to investigate the effects of intervention with Bifidobacterium longum OLP-01 on cognitive function, exercise performance, nutritional status and gut microbiota in stroke patients.

  1. 1.Study population:
  2. 2.Study design:
  3. 3.Anthropometry data: height, weight, body mass index, waist circumference, mid-upper arm circumference, hip circumference, calf circumference, waist to hip ratio.
  4. 4.Body composition: muscle mass, body fat, basal metabolic rate.
  5. 5.Clinical data: blood pressure, stroke related characteristics.
  6. 6.Blood biochemistry:
  7. 7.Gut microbiota: relative abundance, α-diversity, β-diversity.
  8. 8.Nutritional status: 3-day dietary record, mini-nutritional assessment (MNA).
  9. 9.Cognitive function: Montreal cognitive assessment (MoCA), trail-making test A and B (TMT A and B), Stroop color naming test.
  10. 10.Exercise performance: timed up and go test (TUGT), 6-min walking test.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable stroke

Geographic Reach
1 country

3 active sites

Status
unknown

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

February 12, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2023

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 18, 2022

Last Update Submit

July 25, 2022

Conditions

Stroke

Keywords

Bifidobacterium longum OLP-01StrokeCognitive functionExercise performanceNutritional statusGut microbiota

Outcome Measures

Primary Outcomes (36)

  • Montreal cognitive assessment (MoCA)

    Cognitive function

    Week 0

  • Montreal cognitive assessment (MoCA)

    Cognitive function

    Week 12

  • Montreal cognitive assessment (MoCA) (change)

    Cognitive function

    Change from week 0 to week 12

  • Trail-making test A and B (TMT A and B)

    Cognitive function

    Week 0

  • Trail-making test A and B (TMT A and B)

    Cognitive function

    Week 12

  • Trail-making test A and B (TMT A and B) (change)

    Cognitive function

    Change from week 0 to week 12

  • Stroop color naming test

    Cognitive function

    Week 0

  • Stroop color naming test

    Cognitive function

    Week 12

  • Stroop color naming test (change)

    Cognitive function

    Change from week 0 to week 12

  • Timed up and go test (TUGT)

    Exercise performance

    Week 0

  • Timed up and go test (TUGT)

    Exercise performance

    Week 12

  • Timed up and go test (TUGT) (change)

    Exercise performance

    Change from week 0 to week 12

  • 6-min walking test

    Exercise performance

    Week 0

  • 6-min walking test

    Exercise performance

    Week 12

  • 6-min walking test (change)

    Exercise performance

    Change from week 0 to week 12

  • Albumin

    Nutritional Status

    Week 0

  • Albumin

    Nutritional Status

    Week 12

  • Albumin (change)

    Nutritional Status

    Change from week 0 to week 12

  • Pre-albumin

    Nutritional Status

    Week 0

  • Pre-albumin

    Nutritional Status

    Week 12

  • Pre-albumin (change)

    Nutritional Status

    Change from week 0 to week 12

  • Transferrin

    Nutritional Status

    Week 0

  • Transferrin

    Nutritional Status

    Week 12

  • Transferrin (change)

    Nutritional Status

    Change from week 0 to week 12

  • 3-day dietary record

    Nutritional Status

    Week 0

  • 3-day dietary record

    Nutritional Status

    Week 12

  • 3-day dietary record (change)

    Nutritional Status

    Change from week 0 to week 12

  • Mini-nutritional assessment (MNA)

    Nutritional Status

    Week 0

  • Mini-nutritional assessment (MNA)

    Nutritional Status

    Week 12

  • Mini-nutritional assessment (MNA) (change)

    Nutritional Status

    Change from week 0 to week 12

  • Relative abundance

    Gut microbiota Use the 16s RNA sequencing to conduct the next generation sequencing (NGS) measure the relative abundance, including the phylum, class, family, genus.

    Week 0

  • Relative abundance

    Gut microbiota Use the 16s RNA sequencing to conduct the next generation sequencing (NGS) measure the relative abundance, including the phylum, class, family, genus.

    Week 12

  • α-diversity

    Gut microbiota

    Week 0

  • α-diversity

    Gut microbiota

    Week 12

  • β-diversity

    Gut microbiota

    Week 0

  • β-diversity

    Gut microbiota

    Week 12

Secondary Outcomes (103)

  • Height

    Week 0

  • Height

    Week 12

  • Height (change)

    Change from week 0 to week 12

  • Weight

    Week 0

  • Weight

    Week 12

  • +98 more secondary outcomes

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Subjects in placebo group will treat with placebo.

Other: Placebo

Supplement group

EXPERIMENTAL

Subjects in supplement group will treat with Bifidobacterium longum OLP-01.

Dietary Supplement: Bifidobacterium longum OLP-01

Interventions

Bifidobacterium longum OLP-01DIETARY_SUPPLEMENT

Bifidobacterium longum OLP-01 is one of probiotics. Subjects in OLP-01 group will supplement with either 2 × 1010 colony-forming unit (CFU) of Bifidobacterium longum OLP-01 powder per day for 12 weeks.

Supplement group
PlaceboOTHER

Subjects in placebo group will supplement with placebo powder per day for 12 weeks.

Placebo group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20-75 years old
  • Diagnosed with stroke more than 3 months
  • Undergoing outpatient rehabilitation and the condition is stable

You may not qualify if:

  • Aphasia, dementia or depression
  • BMI ≥ 35 kg/m2
  • Cancer treatment in 3 months
  • Some severe disease may interfere patients to join the study
  • Failed to cooperate the examination and treatment because of emotion or mental condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of rehabilitation, ShuangHo Hospital

New Taipei City, Taiwan

Location

Department of rehabilitation, Taipei Medical University Hospital

Taipei, Taiwan

Location

Department of rehabilitation, WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chao Jane C-J, PhD

    Taipei Medical University, Taiwan, R.O.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 28, 2022

Study Start

February 12, 2021

Primary Completion

February 11, 2023

Study Completion

February 11, 2023

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

TW(3)