Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NMRR-19-1761-49477 | Registry Identifier | The National Medical Registry of Malaysia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microbial cell preparation [MCP] | Dietary Supplement | active microbial cell preparation |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in stool output frequency | numerical scale 0-100 used, 0= nil (worst), 100= good, medium score was used for data interpratation | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days |
| patients' perceptions of an improvement in their constipation-related symptoms 2 |
Not provided
Inclusion Criteria:
-clinical diagnosis of constipation
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| hayati Yaakup, MBBS | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiti Kebangsaan Malaysia Medical Faculty | Kuala Lumpur | Kuala Lumpur | 56000 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33244562 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2019 | Jul 24, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003248 | Constipation |
| C564969 | Minicore Myopathy with External Ophthalmoplegia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
The subjects received either the probiotics or a placebo.
Not provided
Not provided
Both investigators and patients were unaware of the assignment and were blinded to the labelling process performed by the sample supplier. The patients were randomly allocated to one of two groups; those who received sample labelled A or B. Emergency code break were kept at the manufacturing factory and no code break was needed throughout the trial duration. Both the MCP and placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets and labelled as A and B. Investigators have no contact with the manufacturing staffs at any point during the trial process. Following data analysis, unblinding was performed to complete the study process.
| placebo | Other | inactive ingredient |
|
sensation of incomplete evacuation: likert score of 0 to 10 was used, 0= total incomplete evacuation, 10=complete evacuation |
| 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 | 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 | 7 days |