AgingProbioticsNCT04035616
Probiotics in Elderly Patients With Medical Conditions
A study testing microbial cell preparation [MCP] in people with Aging and Constipation, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Constipation, Multi-Core Disease
- What is being tested?
- microbial cell preparation [MCP]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2018to 31 Dec 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -clinical diagnosis of constipation
Who cannot join
- Parkinson's disease,
- spinal cord lesions
- post radiation strictures
- on calcium supplements of greater than 1,500 mg per day
- immune-deficiency
- critical illness
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Kebangsaan Malaysia Medical Faculty
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: Evaluation of the Efficacy of Probiotics in Treating Constipation in Elderly Patients With Multiple Chronic Co-morbidities: a Randomized Control Trial
Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation
Read the detailed description
Background and aims:
Probiotics are known to have a beneficial effect on the management of constipation. Thus, the current study objective was to evaluate the impact of a microbial cell preparation (MCP) (Hexbio®; comprising Bifidobacterium and Lactobacillus strains) on stool frequency, consistency, and constipation-related symptoms in elderly patients with multiple chronic medical conditions.
- Conditions
- Aging, Constipation, Multi-Core Disease
- Being tested
- microbial cell preparation [MCP], placebo
- Keywords
- microbial cell preparation, Hexbio®, probiotics, elderly, chronic medical conditions, constipation,
- Medical subject headings
- Constipation, Minicore Myopathy with External Ophthalmoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbial cell preparation [MCP]Dietary supplement
Also called Hexbio®
active microbial cell preparation
placeboOther
inactive ingredient
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets with active comparator and labelled as A Receives: Other: placebo |
| Hexbio® MCP | Active comparator | The treatment sample is labelled as B.This is an orange-flavoured, granulated microbial cell preparation containing 30 billion colony forming units (cfu) of Lactobacilli and Bifidobacteria strains: Lactobacillus acidophilus BCMC® 12130, Lactobacillus casei BCMC® 12313, Lactobacillus lactis BCMC® 12451, Bifidobacterium bifidum BCMC® 02290, Bifidobacterium infantis BCMC®02129, Bifidobacterium longum BCMC® 02120. The placebo sample was similar in appearance and taste, but contained no microbial cells. Receives: Dietary Supplement: microbial cell preparation [MCP] |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in stool output frequency
numerical scale 0-100 used, 0= nil (worst), 100= good, medium score was used for data interpratation
Measured: 7 days
changes in stool consistency
The Bristol Stool scale was used, scale type 1 to 7, type 1 = hard stool and type 7=entirely liquid stool, medium score was used for data intepretation
Measured: 7 days
Secondary outcomes (4)
patients' perceptions of an improvement in their constipation-related symptoms 1
straining: likert score of 0 to 10 was used, 0=no straining, 10= worst straining
Measured: 7 days
patients' perceptions of an improvement in their constipation-related symptoms 2
sensation of incomplete evacuation: likert score of 0 to 10 was used, 0= total incomplete evacuation, 10=complete evacuation
Measured: 7 days
patients' perceptions of an improvement in their constipation-related symptoms 3
sensation of ano-rectal obstruction/blockage: likert score of 0 to 10 was used, 0=complete obstruction, 10= complete relieved
Measured: 7 days
patients' perceptions of an improvement in their constipation-related symptoms 4
Need of manual evacuation to aid defeacation: likert score of 0 to 10 was used, 0=no evacuation needed, 10=total evacuation needed
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Model description
- The subjects received either the probiotics or a placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hayati Yaakup, MBBS, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035616
- Sponsor's protocol ID
- FF-2016-417)
- Other IDs
- NMRR-19-1761-49477
- Acronym
- Probiotics
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghafar MYA, Yaakup H, Ali RAR, Shah SA. Evaluation of the Efficacy of Probiotics (MCP(R) BCMC(R) Strains) Treating Constipation in Elderly Patients with Multiple Chronic Co-Morbidities: A Randomized Control Trial. J Nutr Health Aging. 2020;24(10):1066-1072. doi: 10.1007/s12603-020-1494-1.
PubMed 33244562
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Probiotics in Treating Constipation in Elderly Patients With Multiple Chronic Co-morbidities: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04035616
- Acronym / sponsor ID
- Probiotics / FF-2016-417)
- Conditions
- Aging, Constipation, Multi-Core Disease
- Keywords
- microbial cell preparation, Hexbio®, probiotics, elderly, chronic medical conditions, constipation,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 29 Jul 2019 (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.
Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation
Detailed description
Background and aims:
Probiotics are known to have a beneficial effect on the management of constipation. Thus, the current study objective was to evaluate the impact of a microbial cell preparation (MCP) (Hexbio®; comprising Bifidobacterium and Lactobacillus strains) on stool frequency, consistency, and constipation-related symptoms in elderly patients with multiple chronic medical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The subjects received either the probiotics or a placebo.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboplacebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets with active comparator and labelled as A |
| Hexbio® MCP | Active comparator | Dietary Supplement: microbial cell preparation [MCP]The treatment sample is labelled as B.This is an orange-flavoured, granulated microbial cell preparation containing 30 billion colony forming units (cfu) of Lactobacilli and Bifidobacteria strains: Lactobacillus acidophilus BCMC® 12130, Lactobacillus casei BCMC® 12313, Lactobacillus lactis BCMC® 12451, Bifidobacterium bifidum BCMC® 02290, Bifidobacterium infantis BCMC®02129, Bifidobacterium longum BCMC® 02120. The placebo sample was similar in appearance and taste, but contained no microbial cells. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -clinical diagnosis of constipation
Key exclusion criteria (6 listed)
- Parkinson's disease,
- spinal cord lesions
- post radiation strictures
- on calcium supplements of greater than 1,500 mg per day
- immune-deficiency
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 |
|---|---|---|
| microbial cell preparation [MCP]Also: Hexbio®active microbial cell preparation | Dietary supplement | Hexbio® MCP |
| placeboinactive ingredient | Other | Placebo |
Primary outcome
changes in stool output frequency
Time frame: 7 days
numerical scale 0-100 used, 0= nil (worst), 100= good, medium score was used for data interpratation
changes in stool consistency
Time frame: 7 days
The Bristol Stool scale was used, scale type 1 to 7, type 1 = hard stool and type 7=entirely liquid stool, medium score was used for data intepretation
4 secondary outcomes
patients' perceptions of an improvement in their constipation-related symptoms 1
Time frame: 7 days
patients' perceptions of an improvement in their constipation-related symptoms 2
Time frame: 7 days
patients' perceptions of an improvement in their constipation-related symptoms 3
Time frame: 7 days
patients' perceptions of an improvement in their constipation-related symptoms 4
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 33244562Ghafar MYA, Yaakup H, Ali RAR, Shah SA. Evaluation of the Efficacy of Probiotics (MCP(R) BCMC(R) Strains) Treating Constipation in Elderly Patients with Multiple Chronic Co-Morbidities: A Randomized Control Trial. J Nutr Health Aging. 2020;24(10):1066-1072. doi: 10.1007/s12603-020-1494-1.
- Individual participant dataSharing planned: No
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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.
hayati Yaakup, MBBS principal investigator
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 microbial cell preparation [MCP] in people with Aging and Constipation, run by Universiti Kebangsaan Malaysia Medical Centre 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
changes in stool output frequency (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035616, which also lists 1 linked publication.
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 29 Jul 2019.