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Probiotics in Elderly Patients With Medical Conditions (Probiotics)

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ClinicalTrials.gov Identifier: NCT04035616
Recruitment Status : Completed
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

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

Condition or disease Intervention/treatment Phase
Aging Constipation Multi-Core Disease Dietary Supplement: microbial cell preparation [MCP] Other: placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The subjects received either the probiotics or a placebo.
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Probiotics in Treating Constipation in Elderly Patients With Multiple Chronic Co-morbidities: a Randomized Control Trial
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018


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 Name: Hexbio®




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. patients' perceptions of an improvement in their constipation-related symptoms 1 [ Time Frame: 7 days ]
    straining: likert score of 0 to 10 was used, 0=no straining, 10= worst straining

  2. patients' perceptions of an improvement in their constipation-related symptoms 2 [ Time Frame: 7 days ]
    sensation of incomplete evacuation: likert score of 0 to 10 was used, 0= total incomplete evacuation, 10=complete evacuation

  3. patients' perceptions of an improvement in their constipation-related symptoms 3 [ Time Frame: 7 days ]
    sensation of ano-rectal obstruction/blockage: likert score of 0 to 10 was used, 0=complete obstruction, 10= complete relieved

  4. patients' perceptions of an improvement in their constipation-related symptoms 4 [ Time Frame: 7 days ]
    Need of manual evacuation to aid defeacation: likert score of 0 to 10 was used, 0=no evacuation needed, 10=total evacuation needed



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035616


Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Faculty
Kuala lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Investigators
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Principal Investigator: hayati Yaakup, MBBS National University of Malaysia
  Study Documents (Full-Text)

Documents provided by Universiti Kebangsaan Malaysia Medical Centre:

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Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT04035616     History of Changes
Other Study ID Numbers: FF-2016-417)
NMRR-19-1761-49477 ( Registry Identifier: The National Medical Registry of Malaysia )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universiti Kebangsaan Malaysia Medical Centre:
microbial cell preparation
Hexbio®
probiotics
elderly
chronic medical conditions
constipation,
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms