NCT04035616

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 17, 2019

Last Update Submit

July 24, 2019

Conditions

AgingConstipationMulti-Core Disease

Keywords

microbial cell preparationHexbio®probioticselderlychronic medical conditionsconstipation,

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • patients' perceptions of an improvement in their constipation-related symptoms 1

    7 days

  • patients' perceptions of an improvement in their constipation-related symptoms 2

    7 days

  • patients' perceptions of an improvement in their constipation-related symptoms 3

    7 days

  • patients' perceptions of an improvement in their constipation-related symptoms 4

    7 days

Study Arms (2)

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

Other: placebo

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.

Dietary Supplement: microbial cell preparation [MCP]

Interventions

microbial cell preparation [MCP]DIETARY_SUPPLEMENT

active microbial cell preparation

Also known as: Hexbio®
Hexbio® MCP
placeboOTHER

inactive ingredient

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of constipation

You may not qualify if:

  • Parkinson's disease,
  • spinal cord lesions
  • post radiation strictures
  • on calcium supplements of greater than 1,500 mg per day
  • immune-deficiency
  • critical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Faculty

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 33244562DERIVED

MeSH Terms

Conditions

ConstipationMinicore Myopathy with External Ophthalmoplegia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • hayati Yaakup, MBBS

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The subjects received either the probiotics or a placebo.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 29, 2019

Study Start

September 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)