StrokeNCT05477732
Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients
A study testing Bifidobacterium longum OLP-01 in people with Stroke, run by Taipei Medical University at 3 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bifidobacterium longum OLP-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 3 sitesTaiwan
- Study dates
- 12 Feb 2021to 11 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20-75 years old
- Diagnosed with stroke more than 3 months
- Undergoing outpatient rehabilitation and the condition is stable
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Department of rehabilitation, ShuangHo Hospital
New Taipei City
Department of rehabilitation, Taipei Medical University Hospital
Taipei
Department of rehabilitation, WanFang Hospital
Taipei
About this study
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.
- Study population: We will recruit 120 stroke patients and the inclusion criteria are: (1) Aged 20-75 years old, (2) Diagnosed with stroke more than 3 months, (3) Undergoing outpatient rehabilitation and the condition is stable. The exclusion criteria are: (1) Aphasia, dementia or depression, (2) BMI ≥ 35 kg/m2, (3) Cancer treatment in 3 months, (4) Some severe disease may interfere patients to join the study, (5) Failed to cooperate the examination and treatment because of emotion or mental condition.
- Study design:
Read more
A two-arm single-blind randomized controlled clinical trial will be performed for 12 weeks and the subjects will be divided in to 2 groups: (1) placebo group, (2) supplement group. Subjects were asked to supplement with either 2 × 1010 colony-forming unit (CFU) of Bifidobacterium longum OLP-01 powder per day or placebo for 12 weeks. Medical history, drug use and life style questionnaires were giving before intervention. Outcomes will be assess in week 0 and week 12 during intervention.
- Outcome assessment:
- Anthropometry data: height, weight, body mass index, waist circumference, mid-upper arm circumference, hip circumference, calf circumference, waist to hip ratio.
- Body composition: muscle mass, body fat, basal metabolic rate.
- Clinical data: blood pressure, stroke related characteristics.
- Blood biochemistry:
- Nutritional status: albumin, prealbumin, transferrin.
- Glycemic profiles: fasting blood glucose, glycated hemoglobin A1c (HbA1c).
- Lipid profiles: total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG).
- Complete blood counts: white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC).
- WBC differential counts: neutrophils (NEUT), lymphocytes (LYM), monocytes (MONO), eosinophils (EOS), basophils (BASO).
- C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor alpha (TNF-α).
- Gut microbiota: relative abundance, α-diversity, β-diversity.
- Nutritional status: 3-day dietary record, mini-nutritional assessment (MNA).
- Cognitive function: Montreal cognitive assessment (MoCA), trail-making test A and B (TMT A and B), Stroop color naming test.
- Exercise performance: timed up and go test (TUGT), 6-min walking test.
The purpose of the study is to investigate the intervention of Bifidobacterium longum OLP-01 supplement on cognitive function, physiological performance, nutritional status, and gut microbiota in stroke patients.
- Conditions
- Stroke
- Being tested
- Bifidobacterium longum OLP-01, Placebo
- Keywords
- Bifidobacterium longum OLP-01, Stroke, Cognitive function, Exercise performance, Nutritional status, Gut microbiota
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
Subjects in placebo group will supplement with placebo powder per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Subjects in placebo group will treat with placebo. Receives: Other: Placebo |
| Supplement group | Experimental | Subjects in supplement group will treat with Bifidobacterium longum OLP-01. Receives: Dietary Supplement: Bifidobacterium longum OLP-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal cognitive assessment (MoCA)
Cognitive function
Measured: Week 0
Montreal cognitive assessment (MoCA)
Cognitive function
Measured: Week 12
Montreal cognitive assessment (MoCA) (change)
Cognitive function
Measured: Change from week 0 to week 12
Trail-making test A and B (TMT A and B)
Cognitive function
Measured: Week 0
Trail-making test A and B (TMT A and B)
Cognitive function
Measured: Week 12
Trail-making test A and B (TMT A and B) (change)
Cognitive function
Measured: Change from week 0 to week 12
Stroop color naming test
Cognitive function
Measured: Week 0
Stroop color naming test
Cognitive function
Measured: Week 12
Stroop color naming test (change)
Cognitive function
Measured: Change from week 0 to week 12
Timed up and go test (TUGT)
Exercise performance
Measured: Week 0
Timed up and go test (TUGT)
Exercise performance
Measured: Week 12
Timed up and go test (TUGT) (change)
Exercise performance
Measured: Change from week 0 to week 12
6-min walking test
Exercise performance
Measured: Week 0
6-min walking test
Exercise performance
Measured: Week 12
6-min walking test (change)
Exercise performance
Measured: Change from week 0 to week 12
Albumin
Nutritional Status
Measured: Week 0
Albumin
Nutritional Status
Measured: Week 12
Albumin (change)
Nutritional Status
Measured: Change from week 0 to week 12
Pre-albumin
Nutritional Status
Measured: Week 0
Pre-albumin
Nutritional Status
Measured: Week 12
Pre-albumin (change)
Nutritional Status
Measured: Change from week 0 to week 12
Transferrin
Nutritional Status
Measured: Week 0
Transferrin
Nutritional Status
Measured: Week 12
Transferrin (change)
Nutritional Status
Measured: Change from week 0 to week 12
3-day dietary record
Nutritional Status
Measured: Week 0
3-day dietary record
Nutritional Status
Measured: Week 12
3-day dietary record (change)
Nutritional Status
Measured: Change from week 0 to week 12
Mini-nutritional assessment (MNA)
Nutritional Status
Measured: Week 0
Mini-nutritional assessment (MNA)
Nutritional Status
Measured: Week 12
Mini-nutritional assessment (MNA) (change)
Nutritional Status
Measured: 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.
Measured: 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.
Measured: Week 12
α-diversity
Gut microbiota
Measured: Week 0
α-diversity
Gut microbiota
Measured: Week 12
β-diversity
Gut microbiota
Measured: Week 0
β-diversity
Gut microbiota
Measured: Week 12
Secondary outcomes (103)
Height
Anthropometry data
Measured: Week 0
Height
Anthropometry data
Measured: Week 12
Height (change)
Anthropometry data
Measured: Change from week 0 to week 12
Weight
Anthropometry data
Measured: Week 0
Weight
Anthropometry data
Measured: Week 12
Weight (change)
Anthropometry data
Measured: Change from week 0 to week 12
Body mass index (BMI)
Anthropometry data Weight and height will be combined to report BMI in kg/m^2
Measured: Week 0
Body mass index (BMI)
Anthropometry data Weight and height will be combined to report BMI in kg/m^2
Measured: Week 12
Body mass index (BMI) (change)
Anthropometry data Weight and height will be combined to report BMI in kg/m^2
Measured: Change from week 0 to week 12
Waist circumference
Anthropometry data
Measured: Week 0
Waist circumference
Anthropometry data
Measured: Week 12
Waist circumference (change)
Anthropometry data
Measured: Change from week 0 to week 12
Mid-upper arm circumference
Anthropometry data
Measured: Week 0
Mid-upper arm circumference
Anthropometry data
Measured: Week 12
Mid-upper arm circumference (change)
Anthropometry data
Measured: Change from week 0 to week 12
Hip circumference
Anthropometry data
Measured: Week 0
Hip circumference
Anthropometry data
Measured: Week 12
Hip circumference (change)
Anthropometry data
Measured: Change from week 0 to week 12
Calf circumference
Anthropometry data
Measured: Week 0
Calf circumference
Anthropometry data
Measured: Week 12
Calf circumference (change)
Anthropometry data
Measured: Change from week 0 to week 12
Waist to hip ratio
Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio
Measured: Week 0
Waist to hip ratio
Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio
Measured: Week 12
Waist to hip ratio (change)
Anthropometry data Waist circumference and hip circumference will be combined to report waist to hip ratio
Measured: Change from week 0 to week 12
Muscle mass
Body composition
Measured: Week 0
Muscle mass
Body composition
Measured: Week 12
Muscle mass (change)
Body composition
Measured: Change from week 0 to week 12
Body fat
Body composition
Measured: Week 0
Body fat
Body composition
Measured: Week 12
Body fat (change)
Body composition
Measured: Change from week 0 to week 12
Basal metabolic rate
Body composition
Measured: Week 0
Basal metabolic rate
Body composition
Measured: Week 12
Basal metabolic rate (change)
Body composition
Measured: Change from week 0 to week 12
Blood pressure
Clinical data
Measured: Week 0
Blood pressure
Clinical data
Measured: Week 12
Blood pressure (change)
Clinical data
Measured: Change from week 0 to week 12
Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
Stroke related characteristics would collect form clinical data or ask form subjects directly
Measured: Week 0
Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
Stroke related characteristics would collect form clinical data or ask form subjects directly
Measured: Week 12
Medical history, drug use and life style questionnaires
Clinical data This questionnaires including 3 parts (medical history, drug use and life style). Medical history and drug use will write by subjects. Life style (e.g. smocking habit, exercise frequency) will ask the subjects.
Measured: Week 0
Medical history, drug use and life style questionnaires
Clinical data This questionnaires including 3 parts (medical history, drug use and life style). Medical history and drug use will write by subjects. Life style (e.g. smocking habit, exercise frequency) will ask the subjects.
Measured: Week 12
Fasting blood glucose
Blood biochemistry
Measured: Week 0
Fasting blood glucose
Blood biochemistry
Measured: Week 12
Fasting blood glucose (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Glycated hemoglobin A1c (HbA1c)
Blood biochemistry
Measured: Week 0
Glycated hemoglobin A1c (HbA1c)
Blood biochemistry
Measured: Week 12
Glycated hemoglobin A1c (HbA1c) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Total cholesterol (TC)
Blood biochemistry
Measured: Week 0
Total cholesterol (TC)
Blood biochemistry
Measured: Week 12
Total cholesterol (TC) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
High density lipoprotein cholesterol (HDL-C)
Blood biochemistry
Measured: Week 0
High density lipoprotein cholesterol (HDL-C)
Blood biochemistry
Measured: Week 12
High density lipoprotein cholesterol (HDL-C) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Low density lipoprotein cholesterol (LDL-C)
Blood biochemistry
Measured: Week 0
Low density lipoprotein cholesterol (LDL-C)
Blood biochemistry
Measured: Week 12
Low density lipoprotein cholesterol (LDL-C) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Triglycerides (TG)
Blood biochemistry
Measured: Week 0
Triglycerides (TG)
Blood biochemistry
Measured: Week 12
Triglycerides (TG) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
White blood cells (WBC)
Blood biochemistry
Measured: Week 0
White blood cells (WBC)
Blood biochemistry
Measured: Week 12
White blood cells (WBC) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Red blood cells (RBC)
Blood biochemistry
Measured: Week 0
Red blood cells (RBC)
Blood biochemistry
Measured: Week 12
Red blood cells (RBC) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Hemoglobin (HB)
Blood biochemistry
Measured: Week 0
Hemoglobin (HB)
Blood biochemistry
Measured: Week 12
Hemoglobin (HB) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Platelet count (PLT)
Blood biochemistry
Measured: Week 0
Platelet count (PLT)
Blood biochemistry
Measured: Week 12
Platelet count (PLT) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Hematocrit (HCT)
Blood biochemistry
Measured: Week 0
Hematocrit (HCT)
Blood biochemistry
Measured: Week 12
Hematocrit (HCT) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Mean corpuscular volume (MCV)
Blood biochemistry
Measured: Week 0
Mean corpuscular volume (MCV)
Blood biochemistry
Measured: Week 12
Mean corpuscular volume (MCV) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Mean corpuscular hemoglobin (MCH)
Blood biochemistry
Measured: Week 0
Mean corpuscular hemoglobin (MCH)
Blood biochemistry
Measured: Week 12
Mean corpuscular hemoglobin (MCH) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Mean corpuscular hemoglobin concentration (MCHC)
Blood biochemistry
Measured: Week 0
Mean corpuscular hemoglobin concentration (MCHC)
Blood biochemistry
Measured: Week 12
Mean corpuscular hemoglobin concentration (MCHC) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Neutrophils (NEUT)
Blood biochemistry (WBC counts)
Measured: Week 0
Neutrophils (NEUT)
Blood biochemistry (WBC counts)
Measured: Week 12
Neutrophils (NEUT)
Blood biochemistry (WBC counts)
Measured: Change from week 0 to week 12
Lymphocytes (LYM)
Blood biochemistry (WBC counts)
Measured: Week 0
Lymphocytes (LYM)
Blood biochemistry (WBC counts)
Measured: Week 12
Lymphocytes (LYM)
Blood biochemistry (WBC counts)
Measured: Change from week 0 to week 12
Monocytes (MONO)
Blood biochemistry (WBC counts)
Measured: Week 0
Monocytes (MONO)
Blood biochemistry (WBC counts)
Measured: Week 12
Monocytes (MONO)
Blood biochemistry (WBC counts)
Measured: Change from week 0 to week 12
Eosinophils (EOS)
Blood biochemistry (WBC counts)
Measured: Week 0
Eosinophils (EOS)
Blood biochemistry (WBC counts)
Measured: Week 12
Eosinophils (EOS)
Blood biochemistry (WBC counts)
Measured: Change from week 0 to week 12
Basophils (BASO)
Blood biochemistry (WBC counts)
Measured: Week 0
Basophils (BASO)
Blood biochemistry (WBC counts)
Measured: Week 12
Basophils (BASO)
Blood biochemistry (WBC counts)
Measured: Change from week 0 to week 12
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)
Blood biochemistry (cytokines)
Measured: Week 0
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α)
Blood biochemistry (cytokines)
Measured: Week 12
Interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor alpha (TNF-α) (change)
Blood biochemistry (cytokines)
Measured: Change from week 0 to week 12
C-reactive protein (CRP)
Blood biochemistry
Measured: Week 0
C-reactive protein (CRP)
Blood biochemistry
Measured: Week 12
C-reactive protein (CRP) (change)
Blood biochemistry
Measured: Change from week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start12 Feb 2021
- Primary completion11 Feb 2023 (estimated)
- Study completion11 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Jane C-J, PhD, Principal investigator, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477732
- Sponsor's protocol ID
- N202011038
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bifidobacterium Longum OLP-01 Supplement on Cognitive Function, Exercise Performance, Nutritional Status and Gut Microbiota in Stroke Patients
- ClinicalTrials.gov ID
- NCT05477732
- Acronym / sponsor ID
- N202011038
- Conditions
- Stroke
- Keywords
- Bifidobacterium longum OLP-01, Stroke, Cognitive function, Exercise performance, Nutritional status, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 11 Feb 2023 (estimated)
- Study completion
- 11 Feb 2023 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Study population: We will recruit 120 stroke patients and the inclusion criteria are: (1) Aged 20-75 years old, (2) Diagnosed with stroke more than 3 months, (3) Undergoing outpatient rehabilitation and the condition is stable. The exclusion criteria are: (1) Aphasia, dementia or depression, (2) BMI ≥ 35 kg/m2, (3) Cancer treatment in 3 months, (4) Some severe disease may interfere patients to join the study, (5) Failed to cooperate the examination and treatment because of emotion or mental condition.
- Study design:
A two-arm single-blind randomized controlled clinical trial will be performed for 12 weeks and the subjects will be divided in to 2 groups: (1) placebo group, (2) supplement group. Subjects were asked to supplement with either 2 × 1010 colony-forming unit (CFU) of Bifidobacterium longum OLP-01 powder per day or placebo for 12 weeks. Medical history, drug use and life style questionnaires were giving before intervention. Outcomes will be assess in week 0 and week 12 during intervention.
- Outcome assessment:
- Anthropometry data: height, weight, body mass index, waist circumference, mid-upper arm circumference, hip circumference, calf circumference, waist to hip ratio.
- Body composition: muscle mass, body fat, basal metabolic rate.
- Clinical data: blood pressure, stroke related characteristics.
- Blood biochemistry:
- Nutritional status: albumin, prealbumin, transferrin.
- Glycemic profiles: fasting blood glucose, glycated hemoglobin A1c (HbA1c).
- Lipid profiles: total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG).
- Complete blood counts: white blood cells (WBC), red blood cells (RBC), hemoglobin (HB), platelet count (PLT), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC).
- WBC differential counts: neutrophils (NEUT), lymphocytes (LYM), monocytes (MONO), eosinophils (EOS), basophils (BASO).
- C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumor necrosis factor alpha (TNF-α).
- Gut microbiota: relative abundance, α-diversity, β-diversity.
- Nutritional status: 3-day dietary record, mini-nutritional assessment (MNA).
- Cognitive function: Montreal cognitive assessment (MoCA), trail-making test A and B (TMT A and B), Stroop color naming test.
- Exercise performance: timed up and go test (TUGT), 6-min walking test.
The purpose of the study is to investigate the intervention of Bifidobacterium longum OLP-01 supplement on cognitive function, physiological performance, nutritional status, and gut microbiota in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: PlaceboSubjects in placebo group will treat with placebo. |
| Supplement group | Experimental | Dietary Supplement: Bifidobacterium longum OLP-01Subjects in supplement group will treat with Bifidobacterium longum OLP-01. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 20-75 years old
- Diagnosed with stroke more than 3 months
- Undergoing outpatient rehabilitation and the condition is stable
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium longum OLP-01Bifidobacterium 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. | Dietary supplement | Supplement group |
| PlaceboSubjects in placebo group will supplement with placebo powder per day for 12 weeks. | Other | Placebo group |
Primary outcome
Montreal cognitive assessment (MoCA)
Time frame: Week 0
Cognitive function
Montreal cognitive assessment (MoCA)
Time frame: Week 12
Cognitive function
Montreal cognitive assessment (MoCA) (change)
Time frame: Change from week 0 to week 12
Cognitive function
Trail-making test A and B (TMT A and B)
Time frame: Week 0
Cognitive function
Trail-making test A and B (TMT A and B)
Time frame: Week 12
Cognitive function
Trail-making test A and B (TMT A and B) (change)
Time frame: Change from week 0 to week 12
Cognitive function
Stroop color naming test
Time frame: Week 0
Cognitive function
Stroop color naming test
Time frame: Week 12
Cognitive function
Stroop color naming test (change)
Time frame: Change from week 0 to week 12
Cognitive function
Timed up and go test (TUGT)
Time frame: Week 0
Exercise performance
Timed up and go test (TUGT)
Time frame: Week 12
Exercise performance
Timed up and go test (TUGT) (change)
Time frame: Change from week 0 to week 12
Exercise performance
6-min walking test
Time frame: Week 0
Exercise performance
6-min walking test
Time frame: Week 12
Exercise performance
6-min walking test (change)
Time frame: Change from week 0 to week 12
Exercise performance
Albumin
Time frame: Week 0
Nutritional Status
Albumin
Time frame: Week 12
Nutritional Status
Albumin (change)
Time frame: Change from week 0 to week 12
Nutritional Status
Pre-albumin
Time frame: Week 0
Nutritional Status
Pre-albumin
Time frame: Week 12
Nutritional Status
Pre-albumin (change)
Time frame: Change from week 0 to week 12
Nutritional Status
Transferrin
Time frame: Week 0
Nutritional Status
Transferrin
Time frame: Week 12
Nutritional Status
Transferrin (change)
Time frame: Change from week 0 to week 12
Nutritional Status
3-day dietary record
Time frame: Week 0
Nutritional Status
3-day dietary record
Time frame: Week 12
Nutritional Status
3-day dietary record (change)
Time frame: Change from week 0 to week 12
Nutritional Status
Mini-nutritional assessment (MNA)
Time frame: Week 0
Nutritional Status
Mini-nutritional assessment (MNA)
Time frame: Week 12
Nutritional Status
Mini-nutritional assessment (MNA) (change)
Time frame: Change from week 0 to week 12
Nutritional Status
Relative abundance
Time frame: Week 0
Gut microbiota Use the 16s RNA sequencing to conduct the next generation sequencing (NGS) measure the relative abundance, including the phylum, class, family, genus.
Relative abundance
Time frame: Week 12
Gut microbiota Use the 16s RNA sequencing to conduct the next generation sequencing (NGS) measure the relative abundance, including the phylum, class, family, genus.
α-diversity
Time frame: Week 0
Gut microbiota
α-diversity
Time frame: Week 12
Gut microbiota
β-diversity
Time frame: Week 0
Gut microbiota
β-diversity
Time frame: Week 12
Gut microbiota
103 secondary outcomes
Height
Time frame: Week 0
Height
Time frame: Week 12
Height (change)
Time frame: Change from week 0 to week 12
Weight
Time frame: Week 0
Weight
Time frame: Week 12
Weight (change)
Time frame: Change from week 0 to week 12
Body mass index (BMI)
Time frame: Week 0
Body mass index (BMI)
Time frame: Week 12
Body mass index (BMI) (change)
Time frame: Change from week 0 to week 12
Waist circumference
Time frame: Week 0
Waist circumference
Time frame: Week 12
Waist circumference (change)
Time frame: Change from week 0 to week 12
Mid-upper arm circumference
Time frame: Week 0
Mid-upper arm circumference
Time frame: Week 12
Mid-upper arm circumference (change)
Time frame: Change from week 0 to week 12
Hip circumference
Time frame: Week 0
Hip circumference
Time frame: Week 12
Hip circumference (change)
Time frame: Change from week 0 to week 12
Calf circumference
Time frame: Week 0
Calf circumference
Time frame: Week 12
Calf circumference (change)
Time frame: Change from week 0 to week 12
Waist to hip ratio
Time frame: Week 0
Waist to hip ratio
Time frame: Week 12
Waist to hip ratio (change)
Time frame: Change from week 0 to week 12
Muscle mass
Time frame: Week 0
Muscle mass
Time frame: Week 12
Muscle mass (change)
Time frame: Change from week 0 to week 12
Body fat
Time frame: Week 0
Body fat
Time frame: Week 12
Body fat (change)
Time frame: Change from week 0 to week 12
Basal metabolic rate
Time frame: Week 0
Basal metabolic rate
Time frame: Week 12
Basal metabolic rate (change)
Time frame: Change from week 0 to week 12
Blood pressure
Time frame: Week 0
Blood pressure
Time frame: Week 12
Blood pressure (change)
Time frame: Change from week 0 to week 12
Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
Time frame: Week 0
Stroke related characteristics (including the time since stroke diagnosed, side of lesion, stroke type, use of aid)
Time frame: Week 12
Medical history, drug use and life style questionnaires
Time frame: Week 0
Medical history, drug use and life style questionnaires
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Jane C-J, PhD principal investigator
Taipei Medical University, Taiwan, R.O.C.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum OLP-01 in people with Stroke, run by Taipei Medical University at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal cognitive assessment (MoCA) (time frame: Week 0). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.