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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04035616
Other study ID # FF-2016-417)
Secondary ID NMRR-19-1761-494
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 31, 2018

Study information

Verified date July 2019
Source Universiti Kebangsaan Malaysia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study of efficacy of probiotic in older patients with multiple co-morbidites and constipation


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

-clinical diagnosis of constipation

Exclusion Criteria:

- Parkinson's disease,

- spinal cord lesions

- post radiation strictures

- on calcium supplements of greater than 1,500 mg per day

- immune-deficiency

- critical illness

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
microbial cell preparation [MCP]
active microbial cell preparation
Other:
placebo
inactive ingredient

Locations

Country Name City State
Malaysia Universiti Kebangsaan Malaysia Medical Faculty Kuala lumpur Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in stool output frequency numerical scale 0-100 used, 0= nil (worst), 100= good, medium score was used for data interpratation 7 days
Primary 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
Secondary 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
Secondary 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 7 days
Secondary 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
Secondary 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
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