Probiotics in Elderly Patients With Medical Conditions

Brief Title

Probiotics in Elderly Patients With Medical Conditions

Official Title

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

Brief Summary

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

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


Primary Outcome

changes in stool output frequency

Secondary Outcome

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

Condition

Aging

Intervention

microbial cell preparation [MCP]

Study Arms / Comparison Groups

 Placebo
Description:  placebo were manufactured and supplied by B-Crobes Laboratory Sdn. Bhd. as powder in identical sachets with active comparator and labelled as A

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

100

Start Date

September 1, 2018

Completion Date

December 31, 2018

Primary Completion Date

December 31, 2018

Eligibility 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
      

Gender

All

Ages

60 Years - N/A

Accepts Healthy Volunteers

No

Contacts

hayati Yaakup, MBBS, , 

Location Countries

Malaysia

Location Countries

Malaysia

Administrative Informations


NCT ID

NCT04035616

Organization ID

FF-2016-417)

Secondary IDs

NMRR-19-1761-49477

Responsible Party

Sponsor

Study Sponsor

Universiti Kebangsaan Malaysia Medical Centre


Study Sponsor

hayati Yaakup, MBBS, Principal Investigator, National University of Malaysia


Verification Date

July 2019