Probiotics in Elderly Patients With Medical Conditions

Aging Clinical Trial

— Probiotics  

Official title:

Evaluation of the Efficacy of Probiotics in Treating Constipation in Elderly Patients With Multiple Chronic Co-morbidities: a Randomized Control Trial

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
• 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
• 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

Related Conditions & MeSH terms

• Aging
• Constipation
• Multi-Core Disease

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