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Completed

NCT Number: NCT04035616

Probiotics in Elderly Patients With Medical Conditions

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

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Key information

Conditions

Aging Constipation Minicore Myopathy with External Ophthalmoplegia Multi-Core Disease Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia Medical Faculty

Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microbial cell preparation [MCP]

Dietary Supplement

active microbial cell preparation

Other names: Hexbio®

Placebo

Other

inactive ingredient

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Acronym: Probiotics

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 29, 2019
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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