StrokeNCT07207941
Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients
A study testing Hexbio in people with Stroke, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Hexbio
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Sep 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with moderate ischemic stroke with mRS score of 2-4 from onset of stroke up to 3 months.
- Patients aged 18 to 80 years, who are able to read and write in English and/or Bahasa Malaysia
- Provide informed consent
Who cannot join
- Patients with aphasia
- Patients who have received thrombolysis or mechanical thrombectomy
- Gastrointestinal related diseases such as lactose intolerance, coeliac disease, Renal or hepatic insufficiency (Based on recent six-month blood profile)
- Progressive neurological disease (Alzheimer's disease, Parkinson's Disease, Motor Neuron Disease)
- Pregnancy and breastfeeding.
- Secondary cause of stroke- vasculitis, cerebral venous sinus thrombosis, connective tissue disorders
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- Past history of psychiatric disorders (depression, anxiety)
- Recent use of probiotics and allergies to probiotics
- Immunosuppressed patients (HIV, malignancy)
- Patient with septicemia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
National University of Malaysia
Kuala Lumpur, Kuala Lumpur, 56000
Hui Jan Tan, MD FRCP MMed, 0391455555 ext. 5583, tanhuijan@ukm.edu.my
Nasir Shafiee, Masters in Obs and Gyne, 0391455555, sepukm@ukm.edu.my
About this study
Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients
Read the detailed description
Background:
Stroke survivors often experience reduced quality of life (QoL), impaired activities of daily living (ADL), and high levels of anxiety. Emerging evidence suggests that modulation of the gut-brain axis through probiotics may improve neuropsychological and functional outcomes. However, data from Malaysian populations are lacking.
Objective:
To evaluate the effects of probiotic supplementation compared to placebo on QoL, ADL, anxiety symptoms, and functional outcomes in post-stroke patients.
Study Design:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial.
Methods:
A total of 110 patients with moderate ischemic stroke (mRS 2-4) within 3 months of onset will be recruited from the Neurology Clinic, Hospital Canselor Tuanku Muhriz, Kuala Lumpur. Participants will be randomized (1:1) to receive either:
- Intervention: HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.
- Control: Matching placebo sachets, identical in appearance and schedule. Both groups will continue standard stroke treatment. Primary outcome is QoL measured using the Stroke-Specific Quality of Life (SS-QoL) scale. Secondary outcomes include ADL (Barthel Index), anxiety symptoms (GAD-7), and functional status (mRS score). Assessments will be performed at baseline and 3 months.
Sample Size:
A total of 110 patients (55 per arm) will provide sufficient power to detect clinically meaningful differences, accounting for a 5% dropout rate.
Data Analysis:
Intention-to-treat analysis will be conducted using SPSS v26. Between-group differences will be assessed using appropriate parametric or non-parametric tests, with significance set at p < 0.05.
Study Duration:
Recruitment will begin in Sept 2025 and is expected to complete by May 2028.
Expected Impact:
This study will provide new evidence on the role of probiotics in improving QoL, daily functioning, and psychological well-being among Malaysian post-stroke patients, potentially informing adjunctive rehabilitation strategies.
- Conditions
- Stroke
- Being tested
- Hexbio, Placebo
- Keywords
- stroke, probiotic, quality of life, anxiety, activities of daily living
- Medical subject headings
- Stroke, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HexbioDietary supplement
HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.
PlaceboOther
Matching placebo sachets, identical in appearance and schedule
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Intervention group HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months. Receives: Dietary Supplement: Hexbio |
| Placebo | Placebo comparator | Placebo Control Matching placebo sachets, identical in appearance and schedule. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
QoL measured using the Stroke-Specific Quality of Life (SS-QoL) scale. To assess the patient's quality of life, validated Stroke Specific Quality of life (SS-QoL) questionnaire in English version will be used. This questionnaire consists of 12 domains which includes energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work/productivity. Each question is scored using 5 point Likert scale and the total score is calculated which can range from 49-245. The higher the score, better the quality of life. This questionnaire is validated and requested for permission.
Measured: 3 months
Secondary outcomes (3)
Secondary objectives: Activities of daily living
Activities of daily living is measured using Barthel Index (BI) which contains of 10 items. BI is a measurement scale used to assess an individual's ability to perform activities of daily living (ADL) and mobility. The score ranges from 0-10 and the overall score is calculated. The higher the score, better the functional status.
Measured: 3 months
Secondary objective: Anxiety Score
Anxiety score is calculated using Generalised Anxiety Disorder- 7 (GAD-7) score. GAD 7 is a screening tool and it has 7 items with score ranging from 0-3 for each item and the total score is calculated. The higher the score, the worse the anxiety symptoms. A score of 10 indicates anxiety.
Measured: 3 months
Secondary objective: modified Rankin scale
Modified Rankin Scale (mRS) assess functional recovery and independence after stroke. It uses a 5 point scale, where a higher scale indicates more severe disability.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 May 2028 (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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- B-Crobes Laboratory
- Responsible party
- Principal investigator, Tan Hui Jan, National University of Malaysia
- Investigators
- Nasir Shafiee, Study director, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207941
- Sponsor's protocol ID
- JEP-2025-671
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study has not commenced
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Quality of Life, Activities of Daily Living and Anxiety in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT07207941
- Acronym / sponsor ID
- JEP-2025-671
- Conditions
- Stroke
- Keywords
- stroke, probiotic, quality of life, anxiety, activities of daily living
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- B-Crobes Laboratory
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 6 Oct 2025 (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.
Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients
Detailed description
Background:
Stroke survivors often experience reduced quality of life (QoL), impaired activities of daily living (ADL), and high levels of anxiety. Emerging evidence suggests that modulation of the gut-brain axis through probiotics may improve neuropsychological and functional outcomes. However, data from Malaysian populations are lacking.
Objective:
To evaluate the effects of probiotic supplementation compared to placebo on QoL, ADL, anxiety symptoms, and functional outcomes in post-stroke patients.
Study Design:
This is a single-center, randomized, double-blind, placebo-controlled clinical trial.
Methods:
A total of 110 patients with moderate ischemic stroke (mRS 2-4) within 3 months of onset will be recruited from the Neurology Clinic, Hospital Canselor Tuanku Muhriz, Kuala Lumpur. Participants will be randomized (1:1) to receive either:
- Intervention: HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months.
- Control: Matching placebo sachets, identical in appearance and schedule. Both groups will continue standard stroke treatment. Primary outcome is QoL measured using the Stroke-Specific Quality of Life (SS-QoL) scale. Secondary outcomes include ADL (Barthel Index), anxiety symptoms (GAD-7), and functional status (mRS score). Assessments will be performed at baseline and 3 months.
Sample Size:
A total of 110 patients (55 per arm) will provide sufficient power to detect clinically meaningful differences, accounting for a 5% dropout rate.
Data Analysis:
Intention-to-treat analysis will be conducted using SPSS v26. Between-group differences will be assessed using appropriate parametric or non-parametric tests, with significance set at p < 0.05.
Study Duration:
Recruitment will begin in Sept 2025 and is expected to complete by May 2028.
Expected Impact:
This study will provide new evidence on the role of probiotics in improving QoL, daily functioning, and psychological well-being among Malaysian post-stroke patients, potentially informing adjunctive rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: HexbioIntervention group HEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Control Matching placebo sachets, identical in appearance and schedule. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with moderate ischemic stroke with mRS score of 2-4 from onset of stroke up to 3 months.
- Patients aged 18 to 80 years, who are able to read and write in English and/or Bahasa Malaysia
- Provide informed consent
Key exclusion criteria (10 listed)
- Patients with aphasia
- Patients who have received thrombolysis or mechanical thrombectomy
- Gastrointestinal related diseases such as lactose intolerance, coeliac disease, Renal or hepatic insufficiency (Based on recent six-month blood profile)
- Progressive neurological disease (Alzheimer's disease, Parkinson's Disease, Motor Neuron Disease)
- Pregnancy and breastfeeding.
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 |
|---|---|---|
| HexbioHEXBIO MCP Granule probiotics (Lactobacillus acidophilus, L. casei, L. lactis, Bifidobacterium bifidum, B. infantis, B. longum), one sachet twice daily for 3 months. | Dietary supplement | Intervention |
| PlaceboMatching placebo sachets, identical in appearance and schedule | Other | Placebo |
Primary outcome
Primary Objective
Time frame: 3 months
QoL measured using the Stroke-Specific Quality of Life (SS-QoL) scale. To assess the patient's quality of life, validated Stroke Specific Quality of life (SS-QoL) questionnaire in English version will be used. This questionnaire consists of 12 domains which includes energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision, and work/productivity. Each question is scored using 5 point Likert scale and the total score is calculated which can range from 49-245. The higher the score, better the quality of life. This questionnaire is validated and requested for permission.
3 secondary outcomes
Secondary objectives: Activities of daily living
Time frame: 3 months
Secondary objective: Anxiety Score
Time frame: 3 months
Secondary objective: modified Rankin scale
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: Undecided. Study has not commenced
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Nasir Shafiee study director
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hexbio in people with Stroke, run by National University of Malaysia at 1 site in Malaysia.
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 10 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: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Jan Tan, MD FRCP MMed (+60391455555 ext. 5583, tanhuijan@ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: 3 months). 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 6 Oct 2025.