DiarrheaPhase 4NCT02949882
Improving Bowel Habits of Elderly With Probiotics and Non-probiotics
A Phase 4 study testing Yakult and Dairy Peach Drink (AH Basic) in people with Diarrhea and Constipation, run by Athena Institute, Netherlands.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Constipation
- What is being tested?
- Yakult and Dairy Peach Drink (AH Basic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Resident of nursing home
- Age of ≥ 70 year
Who cannot join
- Participant is seriously ill
- Immune deficient
- Intensive medication
- Life expectancy of ≤ 6 months
- Lactose intolerance
- Cow milk allergy - Stoma
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing a Probiotic and Non-probiotic Intervention in Their Ability to Improve Bowel Habits of Residents in Nursing Homes
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.
Read the 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.
- Conditions
- Diarrhea, Constipation
- Being tested
- Yakult, Dairy Peach Drink (AH Basic)
- Keywords
- Diarrhea, Constipation, Elderly, Nursing Homes, Probiotics, Bowel Habits
- Medical subject headings
- Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YakultDietary supplement
Containing at least 6,5*10^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS)
Dairy Peach Drink (AH Basic)Dietary supplement
Commercially available dairy drink with peach flavour.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Intervention | Experimental | 130 Elderly participants receiving daily 65ml Yakult for 10 consecutive weeks. Receives: 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. Receives: Dietary Supplement: Dairy Peach Drink (AH Basic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (1)
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
- Insufficient criteria for irritable bowel syndrome
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startApr 2017
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athena Institute, Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Europe BV
- Responsible party
- Principal investigator, Eric Claassen, Athena Institute, Netherlands
- Investigators
- Eric Claassen, Prof. Dr., Principal investigator, Athena Institute, Free University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949882
- Sponsor's protocol ID
- 14NL-1-TLM-CON2
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2016
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Probiotic and Non-probiotic Intervention in Their Ability to Improve Bowel Habits of Residents in Nursing Homes
- ClinicalTrials.gov ID
- NCT02949882
- Acronym / sponsor ID
- 14NL-1-TLM-CON2
- Conditions
- Diarrhea, Constipation
- Keywords
- Diarrhea, Constipation, Elderly, Nursing Homes, Probiotics, Bowel Habits
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Athena Institute, NetherlandsUniversity, hospital or other
- Collaborators
- Yakult Europe BV
- Study start
- Apr 2017
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Intervention | Experimental | Dietary Supplement: Yakult130 Elderly participants receiving daily 65ml Yakult for 10 consecutive weeks. |
| Non-Probiotic Intervention | Active comparator | Dietary Supplement: Dairy Peach Drink (AH Basic)130 Elderly participants receiving daily 65 ml of Dairy Peach Drink (AH Basic) for 10 consecutive weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Resident of nursing home
- Age of ≥ 70 year
Key exclusion criteria (9 listed)
- Participant is seriously ill
- Immune deficient
- Intensive medication
- Life expectancy of ≤ 6 months
- Lactose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YakultContaining at least 6,5*10^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS) | Dietary supplement | Probiotic Intervention |
| Dairy Peach Drink (AH Basic)Commercially available dairy drink with peach flavour. | Dietary supplement | Non-Probiotic Intervention |
Primary outcome
Stool Quality
Time frame: 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
1 secondary outcome
Defecation Frequency
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2016.
- Executive organisation (Clinical Research Rotterdam)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Claassen, Prof. Dr. principal investigator
Athena Institute, Free University of Amsterdam
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yakult and Dairy Peach Drink (AH Basic) in people with Diarrhea and Constipation, run by Athena Institute, Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joost Flach, MSc (+(31) 6 40275130, joost.flach@cr2o.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool Quality (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2016.