NCT07207941

Brief Summary

Research on Effect of probiotics on quality of life, activities of daily living and anxiety in post stroke patients

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for not_applicable stroke

Timeline
25mo left

Started Sep 2025

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress23%
Sep 2025May 2028

First Submitted

Initial submission to the registry

September 16, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Expected
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

Same day

First QC Date

September 16, 2025

Last Update Submit

September 26, 2025

Conditions

Stroke

Keywords

strokeprobioticquality of lifeanxietyactivities of daily living

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Secondary objectives: Activities of daily living

    3 months

  • Secondary objective: Anxiety Score

    3 months

  • Secondary objective: modified Rankin scale

    3 months

Study Arms (2)

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.

Dietary Supplement: Hexbio

Placebo

PLACEBO COMPARATOR

Placebo Control Matching placebo sachets, identical in appearance and schedule.

Other: Placebo

Interventions

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.

Intervention
PlaceboOTHER

Matching placebo sachets, identical in appearance and schedule

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Past history of psychiatric disorders (depression, anxiety)
  • Recent use of probiotics and allergies to probiotics
  • Immunosuppressed patients (HIV, malignancy)
  • Patient with septicemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Malaysia

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

StrokeAnxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMental Disorders

Study Officials

  • Nasir Shafiee

    National University of Malaysia

    STUDY DIRECTOR

Central Study Contacts

Hui Jan Tan, MD FRCP MMed

CONTACT

+60391455555tanhuijan@ukm.edu.my

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Neurologist

Study Record Dates

First Submitted

September 16, 2025

First Posted

October 6, 2025

Study Start

September 30, 2025

Primary Completion

September 30, 2025

Study Completion (Estimated)

May 31, 2028

Last Updated

October 6, 2025

Record last verified: 2025-09

Locations

MY(1)