Improving Bowel Habits of Elderly With Probiotics and Non-probiotics

Sponsor

Athena Institute, Netherlands (Other)

Overall Status

Unknown status

CT.gov ID

NCT02949882

Collaborator

Yakult Europe BV (Industry)

260

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea Constipation	Dietary Supplement: Yakult Dietary Supplement: Dairy Peach Drink (AH Basic)	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparing a Probiotic and Non-probiotic Intervention in Their Ability to Improve Bowel Habits of Residents in Nursing Homes

Study Start Date :

Apr 1, 2017

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic Intervention 130 Elderly participants receiving daily 65ml Yakult for 10 consecutive weeks.	Dietary Supplement: Yakult Containing at least 6,5*10^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS)
Active Comparator: Non-Probiotic Intervention 130 Elderly participants receiving daily 65 ml of Dairy Peach Drink (AH Basic) for 10 consecutive weeks.	Dietary Supplement: Dairy Peach Drink (AH Basic) Commercially available dairy drink with peach flavour.

Arm

Intervention/Treatment

Experimental: Probiotic Intervention

130 Elderly participants receiving daily 65ml Yakult for 10 consecutive weeks.

Dietary Supplement: Yakult

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

Active Comparator: Non-Probiotic Intervention

130 Elderly participants receiving daily 65 ml of Dairy Peach Drink (AH Basic) for 10 consecutive weeks.

Dietary Supplement: Dairy Peach Drink (AH Basic)

Commercially available dairy drink with peach flavour.

Outcome Measures

Primary Outcome Measures

Stool Quality [10 weeks]
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. Stool quality: will be monitored using the 7-point Bristol stool chart. Type 1 & 2 stools are associated with constipation, stool type 3 & 4 are characterized as ideal stools, type 5,6 & 7 stools are associated with diarrhoea. Bristol stool chart: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid

Secondary Outcome Measures

Defecation Frequency [10 weeks]
Defecation frequency: will be calculated from the number of stools per time-unit. The frequency of defecation will be related to the Rome III criteria. For functional constipation a patient must fulfill the following diagnostic criteria: Fewer than three defecations per week Loose stools are rarely present without the use of laxatives Insuﬃcient criteria for irritable bowel syndrome

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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