NCT02541539

Brief Summary

This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ) in prevention of upper respiratory and gastrointestinal illnesses, which are found common among adults in Malaysia aged from 18 to 81 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 24, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

August 24, 2015

Last Update Submit

November 2, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Serum immunoglobulin-A (IgA) level

    IgA as an indicator for immunology, in assessing severity of upper respiratory illnesses between number of adult participants taking LCZ vs. placebo

    12 months

  • Bristol stool chart scale

    Bristol stool scale (from a scale of 1-7; scale of 1 representing hard lump, and 7 representing liquid with no solid pieces) as an indicator for assessing severity of gastrointestinal-related diarrheal illnesses between number of adult participants taking LCZ vs. placebo

    12 months

Secondary Outcomes (1)

  • Fecal microbiota profiling

    12 months

Study Arms (2)

Lactobacillus casei Zhang

ACTIVE COMPARATOR

Intervention consists of daily administration of 2g probiotic Lactobacillus casei Zhang, administered daily at a fixed dosage of 9 log CFU/sachet/day and continue for 12 months.

Dietary Supplement: Lactobacillus casei Zhang

Placebo

PLACEBO COMPARATOR

Intervention consists of daily administration of 2g placebo (no probiotic bacteria), administered daily and continue for 12 months.

Dietary Supplement: Placebo

Interventions

Lactobacillus casei ZhangDIETARY_SUPPLEMENT

This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.

Also known as: LCZ
Lactobacillus casei Zhang
PlaceboDIETARY_SUPPLEMENT

This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.

Placebo

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/ female subjects
  • years old
  • Body mass index (BMI) within a healthy range
  • Willing to commit throughout the experiment

You may not qualify if:

  • Type-1 diabetes
  • Long term medication due to certain severe illness
  • Human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS)
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Vegetarian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Industrial Technology, Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11800, Malaysia

Location

Related Publications (1)

  • Zhang J, Wang L, Guo Z, Sun Z, Gesudu Q, Kwok L, Menghebilige, Zhang H. 454 pyrosequencing reveals changes in the faecal microbiota of adults consuming Lactobacillus casei Zhang. FEMS Microbiol Ecol. 2014 Jun;88(3):612-22. doi: 10.1111/1574-6941.12328.

    PMID: 24702028RESULT

Study Officials

  • Min tze Liong, PhD

    USM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

August 24, 2015

First Posted

September 4, 2015

Study Start

October 1, 2015

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

MY(1)