Clinical trial NCT02949882: Improving Bowel Habits of Elderly With Probiotics and Non-probiotics
Official title: Comparing a Probiotic and Non-probiotic Intervention in Their Ability to Improve Bowel Habits of Residents in Nursing Homes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diarrhea
Constipation
Keywords: Diarrhea
Constipation
Elderly
Nursing Homes
Probiotics
Bowel Habits
Lead sponsor: Athena Institute, Netherlands
Sponsor class: OTHER
Collaborators: name: Yakult Europe BV
First posted: 2016-10-31
Enrollment: 260
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objective is to assess the effect of a probiotic intervention and a non-probiotic intervention on bowel habits of elderly (\>80 years on average) in several nursing homes in the Netherlands.

A randomized, double-blind, superiority, multicentre trial. In this trial a probiotic fermented milk drink will be compared to a non-probiotic drink on its potential to improve bowel habits. Both drinks are commercially available in the supermarket. After a run-in period of 2 weeks, 260 subjects will be randomized (1:1) into either the probiotic fermented milk arm (n=130) or the non-probiotic drink arm (n=130), both for a period of 10 weeks.

The study population consists of 260 frail elderly of relatively high age (\>80 years old on average) living in several nursing homes in The Netherlands. One arm receives daily one bottle (65 ml) of Yakult Original (YOR), a probiotic fermented milk drink containing at least 6,5\*10\^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS), for 10 consecutive weeks without changing the regular diet. The other arm will receive a dairy milk drink (AH Basic Dairy Peach Drink, 65 mL) for 10 consecutive weeks, also without changing the regular diet.

The change in bowel habits of the subjects will be measured according to two main study parameters; (a) Stool-quality according to the 7-point Bristol stool chart, and (b) defecation frequency, measured as number of stools per time unit.

Eligibility criteria: Inclusion Criteria:

* Resident of nursing home
* Age of ≥ 70 year

Exclusion Criteria:

* Participant is seriously ill
* Immune deficient
* Intensive medication
* Life expectancy of ≤ 6 months
* Lactose intolerance
* Cow milk allergy - Stoma
* Major gastro-intestinal surgery in the past (e.g. bowel resection, gastric bypass)
* IBD
* Currently using a probiotic product, and not willing to stop this 4 weeks prior to the start of the study

Primary outcomes:
measure: Stool Quality
timeFrame: 10 weeks
Secondary outcomes:
measure: Defecation Frequency
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Athena Institute, Free University of Amsterdam
name: Eric Claassen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: