Improving Bowel Habits of Elderly With Probiotics and Non-probiotics

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02949882
• Other study ID #: 14NL-1-TLM-CON2
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 28, 2016
• Last updated: November 16, 2016
• Start date: April 2017
• Est. completion date: August 2017

Study information

• Verified date: November 2016
• Source: Athena Institute, Netherlands
• Contact: Joost Flach, MSc
• Phone: +(31) 6 40275130
• Email: joost.flach[@]cr2o.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Diarrhea

Intervention

Dietary Supplement:
• Yakult
Containing at least 6,5*10^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS)
• Dairy Peach Drink (AH Basic)
Commercially available dairy drink with peach flavour.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Athena Institute, Netherlands	Yakult Europe BV

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Quality	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	10 weeks	No
Secondary	Defecation Frequency	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; Insu?cient criteria for irritable bowel syndrome	10 weeks	No

External Links

•   Executive organisation (Clinical Research Rotterdam)