Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001220459
Ethics application status
Approved
Date submitted
1/08/2016
Date registered
2/09/2016
Date last updated
24/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Lactobacillus plantarum PS128 on geriatrics: survey on intestinal function and quality of life
Scientific title
The effects of Lactobacillus plantarum PS128 capsules on geriatrics: survey on intestinal function and quality of life
Secondary ID [1] 289586 0
Nil known
Universal Trial Number (UTN)
U1111-1184-8564
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intestinal function 299341 0
quality of life 299342 0
Condition category
Condition code
Oral and Gastrointestinal 299327 299327 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychobiotics is a group of probiotics which represents beneficial effects to mental health. Lactobacillus plantarum PS128 (PS128) is a recently published psychobiotic. This trial aimed at investigating the effects of PS128 on the intestinal function and quality of life on geriatrics.
This trial will include people who were aged more than or equal to 60 and can listen, speak, read and write traditional Chinese. People who were prescribed to use antibiotics within 2 weeks or ingest probiotics products within 2 weeks will be excluded. Subjects will randomly assign to PS128 group or placebo group. After inclusion, the subjects will take PS128 (3 × 10^10 CFU) or placebo (microcrystalline cellulose) capsule after breakfast for 28 days.
Five questionnaires used in this trial were completed by subjects on day 0 and day 28, including Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS), WHOQOL-BREF, Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS) and Geriatric Depression Scale-30. Subject who was institutionalized elderly at collaborative elderly center will collect blood sample on day 0 and day 28. The subjects adherence will be monitored by checking the returning capsule packet.
Intervention code [1] 295190 0
Treatment: Other
Comparator / control treatment
The placebo control will be the control group of this trial. Participants in this group will be given 400 mg of microcrystalline cellulose in a capsule. Participants will consume orally one placebo capsule daily with water for 28 days. All the scoring measured and sample collection are the same of all participants.
Control group
Placebo

Outcomes
Primary outcome [1] 298804 0
Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS)
Timepoint [1] 298804 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Primary outcome [2] 298805 0
Quality of life; assessed by using WHOQOL-BREF questionnaire
Timepoint [2] 298805 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Secondary outcome [1] 325252 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 325252 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Secondary outcome [2] 325253 0
Epworth Sleepiness Scale (ESS)
Timepoint [2] 325253 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Secondary outcome [3] 325254 0
Geriatric Depression Scale-30
Timepoint [3] 325254 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.
Secondary outcome [4] 325255 0
Serum levels of dehydroepiandrosterone sulfate (DHEA-S)
Timepoint [4] 325255 0
Subjects are assessed at baseline and day 28 for changes between 2 timepoints.

Eligibility
Key inclusion criteria
This trial will include people who were aged more than or equal to 60 and can listen, speak, read and write traditional Chinese.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who were prescribed to use antibiotics within 2 weeks or ingest probiotics products within 2 weeks will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was done by numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
8/09/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 7991 0
Taiwan, Province Of China
State/province [1] 7991 0

Funding & Sponsors
Funding source category [1] 293974 0
Commercial sector/Industry
Name [1] 293974 0
Bened Biomedical Co., Ltd.
Country [1] 293974 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Shu-Tzu Cheng
Address
Department of Family Studies and Child Development, Shih Chieh University.
No.70, Dazhi St., Zhongshan Dist., Taipei City 104, Taiwan (R.O.C.)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 292788 0
None
Name [1] 292788 0
Address [1] 292788 0
Country [1] 292788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295389 0
Institutional Review Board of Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
Ethics committee address [1] 295389 0
No.210, Sec.1, Zhongzheng Rd., Donggang Township, Pingtung County 928, Taiwan, ROC
Ethics committee country [1] 295389 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 295389 0
29/03/2016
Approval date [1] 295389 0
15/05/2016
Ethics approval number [1] 295389 0
16-028-A2

Summary
Brief summary
Psychobiotics is a group of probiotics which represents beneficial effects to mental health. Lactobacillus plantarum PS128 (PS128) is a recently published psychobiotic. This trial aimed at investigating the effects of PS128 on the intestinal function and quality of life on geriatrics. This trial will include people who were aged more than or equal to 60 and can listen, speak, read and write traditional Chinese. Five questionnaires used in this trial were completed by subjects on day 0 and day 28, including Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome (GSRS-IBS), WHOQOL-BREF, Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS) and Geriatric Depression Scale-30. Subject who was institutionalized elderly at collaborative elderly center will collect blood sample.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66830 0
A/Prof Shu-Tzu Cheng
Address 66830 0
Department of Family Studies and Child Development, Shih Chieh University.
No.70, Dazhi St., Zhongshan Dist., Taipei City 104, Taiwan (R.O.C.)
Country 66830 0
Taiwan, Province Of China
Phone 66830 0
+886-2-25381111 ext.6912
Fax 66830 0
Email 66830 0
[email protected]
Contact person for public queries
Name 66831 0
Dr Yen-Wenn Liu
Address 66831 0
Institute of Biochemistry and Molecular Biology, National Yang-Ming University.
No. 155, Sec. 2, Linong St., Beitou Dist., Taipei 11221, Taiwan ROC
Country 66831 0
Taiwan, Province Of China
Phone 66831 0
+886-2-28267000 ext. 5641
Fax 66831 0
Email 66831 0
[email protected]
Contact person for scientific queries
Name 66832 0
Dr Yen-Wenn Liu
Address 66832 0
Institute of Biochemistry and Molecular Biology, National Yang-Ming University.
No. 155, Sec. 2, Linong St., Beitou Dist., Taipei 11221, Taiwan ROC
Country 66832 0
Taiwan, Province Of China
Phone 66832 0
+886-2-28267000 ext. 5641
Fax 66832 0
Email 66832 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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