NCT02949882

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

October 28, 2016

Last Update Submit

November 16, 2016

Conditions

DiarrheaConstipation

Keywords

DiarrheaConstipationElderlyNursing HomesProbioticsBowel Habits

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Defecation Frequency

    10 weeks

Study Arms (2)

Probiotic Intervention

EXPERIMENTAL

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

Dietary Supplement: Yakult

Non-Probiotic Intervention

ACTIVE COMPARATOR

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

Dietary Supplement: Dairy Peach Drink (AH Basic)

Interventions

YakultDIETARY_SUPPLEMENT

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

Probiotic Intervention
Dairy Peach Drink (AH Basic)DIETARY_SUPPLEMENT

Commercially available dairy drink with peach flavour.

Non-Probiotic Intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Resident of nursing home
  • Age of ≥ 70 year

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

DiarrheaConstipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Claassen, Prof. Dr.

    Athena Institute, Free University of Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost Flach, MSc

CONTACT

+(31) 6 40275130joost.flach@cr2o.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 28, 2016

First Posted

October 31, 2016

Study Start

April 1, 2017

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

November 17, 2016

Record last verified: 2016-11