Probiotics in Elderly Patients With Medical Conditions (Probiotics)

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

Study Overview

• Status: Completed
• Conditions: Constipation; Aging; Multi-Core Disease
• Intervention / Treatment: Other: placebo; Dietary supplement: microbial cell preparation [MCP]

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
      • Universiti Kebangsaan Malaysia Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets with active comparator and labelled as A	Other: placebo; inactive ingredient
Active Comparator: Hexbio® 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.	Dietary supplement: microbial cell preparation [MCP]; active microbial cell preparation; Other Names: Hexbio®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: hayati Yaakup, MBBS, National University of Malaysia

Publications and helpful links

General Publications

• Ghafar MYA, Yaakup H, Ali RAR, Shah SA. Evaluation of the Efficacy of Probiotics (MCP® BCMC® 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: elderly; probiotics; microbial cell preparation; Hexbio®; chronic medical conditions; constipation,
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: FF-2016-417); NMRR-19-1761-49477 (Registry Identifier: The National Medical Registry of Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No