MedTrace Logo

Improving Bowel Habits of Elderly With Probiotics and Non-probiotics

NCT02949882 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2016-11-17

No results posted yet for this study

Summary

There is a relative high prevalence of constipation and antibiotic-associated diarrhoea (AAD) in the elderly residents of nursing homes, mainly due to high antibiotic and medication usage. Constipation and diarrhoea causes a substantial burden on lives of the frail elderly and significantly reduces the quality of life (QoL). In addition, these circumstances lead to a higher workload for healthcare workers and treatment of constipation and diarrhoea increase costs in healthcare. There are indications that the gastrointestinal microbiome is altered in conditions, such as constipation and AAD. Research indicates that probiotics show potential in the treatment of constipation, AAD and infectious diarrhoea. Probiotics can restore the aberrant gastrointestinal microbiome and thereby possibly treat/prevent constipation and diarrhoea in the frail elderly population. To illustrate, a previous pilot study of probiotic administration in elderly residents of a nursing home demonstrated a reduced prevalence of constipation and diarrhoea stool types and a higher prevalence of ideal stool types during the intervention compared to the baseline period. These promising results demand for a confirmatory study in this population.

Conditions

Interventions

DIETARY_SUPPLEMENT

Yakult

Containing at least 6,5\*10\^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS)

DIETARY_SUPPLEMENT

Dairy Peach Drink (AH Basic)

Commercially available dairy drink with peach flavour.

Sponsors & Collaborators

  • Yakult Europe BV

    collaborator INDUSTRY

  • Athena Institute, Netherlands

    lead OTHER

Principal Investigators

  • Eric Claassen, Prof. Dr. · Athena Institute, Free University of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2017-07-31
Completion
2017-08-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02949882 on ClinicalTrials.gov