HealthyNCT03188302
Evaluation of New Method for Measuring Stool Consistency
A study testing Collection of stool samples in people with Healthy, run by Yakult Honsha European Research Center, ESV at 1 site in Belgium.
Trial summary
This study is designed to validate a new direct method for the measurement of stool consistency, using Texture Analyser. Forty healthy subjects are enrolled in this trial for collection of stool samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Collection of stool samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jun 2017to 6 Jul 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any study-related activities.
- Healthy female or male aged 18 years (inclusive) or older.
- Is willing and able to provide at least 3 stool samples during 2 collection periods of approximately 60 hours, to store the samples in appropriate conditions and to return the samples within the required timeframe.
- Is willing and able to complete a diary during the stool collection periods in order to collect information about form of the stools (based on the Bristol Stool Form Scale classification), bowel habit and sleep habit.
- Understands the Dutch or English language (reading, writing, speaking).
Who cannot join
- Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in this trial.
- Is treated (i.e., currently treated, treated within 1 month before inclusion) for constipation, diarrhoea or any other illness, by use of antibiotics or any other treatment with impact on defecation.
- Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant.
- Is unable to refrain from or anticipates the use of disallowed medications, e.g., antibiotics, laxatives, anti-diarrheal medication.
- Has any history of drug and/or alcohol abuse.
- Any clinically significant disease which in the Investigator's opinion could interfere with the safety of study participants or with the results of the study.
- Participation in another interventional clinical study or receipt of any investigational product within 1 month before visit 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New Method for Measuring Stool Consistency, Using a Texture Analyser (TA.XT Express Texture Analyser)
This study is designed to validate a new direct method for the measurement of stool consistency, using Texture Analyser. Forty healthy subjects are enrolled in this trial for collection of stool samples. Every stool produced during 2 collection periods of approximately 60 hours each is collected and subjected to the measurement of consistency using Texture Analyser. The stool consistency results are compared with the Bristol Stool Form Scale scores for each stool. The relationships of stool consistency with other stool parameters, bowel habit and sleeping habit are also evaluated.
Read the detailed description
It is now obvious that the proper functioning of the gastrointestinal tract has a positive effect on the quality of life. Normal bowel habits vary considerably from person to person with regard to frequency of bowel movements, and bulk and consistency of stools. Constipation is the common digestive complaint in European populations, and softening stool consistency can be regarded as beneficial for such population in terms of reducing incidence of hard or lumpy stools .
The Bristol Stool Form Scale (BS) is validated as a surrogate measure for gastrointestinal transit time, and has been also applied to an evaluation of stool consistency. Subjects compare their stool with the BS chart consisting of seven categories and choose one score which has a nearest analog form. The BS has been widely used in the studies to evaluate changes in stool consistency after dietary intervention using probiotics and/or prebiotics. However, there is a lack of evidence in the validity of BS to yield consistent and reproducible estimates of changes in stool consistency over time. In order to obtain a closer estimate of its change, it would be preferred to use a more directly observable and objective parameter or combination of parameters.
From the above mentioned backgrounds, this study is conducted to validate a new direct method for the measurement of stool consistency, using Texture Analyser: TA.XTExpress Texture Analyser (Stable Micro Systems Ltd.).
- Conditions
- Healthy
- Being tested
- Collection of stool samples
- Keywords
- Stool consistency, Texture Analyser, Bristol Stool Form Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of stool samplesOther
The subjects collect stool samples to be used for validation of a new direct measurement of stool consistency. Every stool sample produced during 2 collection periods of approximately 60 hours each have to be collected using the Commode Specimen Collection System (Medline Industries, Inc.). Each collection period starts preferably in the evening (20h00) and ends 3 days later in the morning (08h00). The collected samples must be stored at subject's home in a refrigerator provided by the sponsor until handover to the site staff.
| Study group | Role | What they receive |
|---|---|---|
| Specimen collection | Other | Collection of stool samples Receives: Other: Collection of stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency
Stool consistency is measured as force (g) during compression by Texture Analyser. A cylinder probe is put vertically into the object with a constant speed and the force is measured when reaching down to the target (5 mm down from the surface) as an outcome.
Measured: Two stool collection periods of approximately 60 hours each
Secondary outcomes (9)
Bristol Stool Form Scale score
Bristol Stool Form Scale (BS) is for classifying the form of stool into 7 categories scored from 1 to 7; (1) Separate hard lumps like nuts (difficult to pass); (2) Sausage-shaped but lumpy; (3) Like a sausage but with cracks on its surface; (4) Like a sausage or snake, smooth and soft; (5) Soft blobs with clear-cut edges (passed easily); (6) Fluffy pieces with ragged edges, a mushy stool; (7) Watery, no solid pieces, entirely liquid. Subjects choose one of the BS scores which has a nearest analog form with their stools at every defecation.
Measured: Two stool collection periods of approximately 60 hours each
Stool water content
Percentage of water in stool (weight/weight %)
Measured: Two stool collection periods of approximately 60 hours each
Stool mucin
Concentration of mucin in stool
Measured: Two stool collection periods of approximately 60 hours each
Stool pH
Degree of stool pH
Measured: Two stool collection periods of approximately 60 hours each
Stool metabolites
Concentrations of stool metabolites including organic acids
Measured: Two stool collection periods of approximately 60 hours each
Stool microbiota composition
Relative abundance of microbiota species (% of total) in stool
Measured: Two stool collection periods of approximately 60 hours each
Stool amount
Weight (g) of stool produced in each defecation
Measured: Two stool collection periods of approximately 60 hours each
Bowel habit
Presence or absence of straining during evacuation, presence or absence of sensation of remaining stool in the rectum after evacuation
Measured: Two stool collection periods of approximately 60 hours each
Sleep habit
Getting-up time, going-to-bed time and sleeping hours
Measured: Two stool collection periods of approximately 60 hours each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start2 Jun 2017
- Primary completion6 Jul 2017
- Study completion6 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yakult Honsha European Research Center, ESV
- Sponsor type
- University, hospital or other
- Collaborators
- Harmony Clinical Research BVBA
- Responsible party
- Sponsor
- Investigators
- Ignace Demeyer, Dr., Principal investigator, Onze-Lieve-Vrouw Hospital Aalst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188302
- Sponsor's protocol ID
- YHER16-TAXT
- Status last verified
- Nov 2017
- First submitted
- 8 Jun 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Method for Measuring Stool Consistency, Using a Texture Analyser (TA.XT Express Texture Analyser)
- ClinicalTrials.gov ID
- NCT03188302
- Acronym / sponsor ID
- YHER16-TAXT
- Conditions
- Healthy
- Keywords
- Stool consistency, Texture Analyser, Bristol Stool Form Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yakult Honsha European Research Center, ESVUniversity, hospital or other
- Collaborators
- Harmony Clinical Research BVBA
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 6 Jul 2017 (actual)
- First posted
- 15 Jun 2017 (actual)
- 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.
This study is designed to validate a new direct method for the measurement of stool consistency, using Texture Analyser. Forty healthy subjects are enrolled in this trial for collection of stool samples. Every stool produced during 2 collection periods of approximately 60 hours each is collected and subjected to the measurement of consistency using Texture Analyser. The stool consistency results are compared with the Bristol Stool Form Scale scores for each stool. The relationships of stool consistency with other stool parameters, bowel habit and sleeping habit are also evaluated.
Detailed description
It is now obvious that the proper functioning of the gastrointestinal tract has a positive effect on the quality of life. Normal bowel habits vary considerably from person to person with regard to frequency of bowel movements, and bulk and consistency of stools. Constipation is the common digestive complaint in European populations, and softening stool consistency can be regarded as beneficial for such population in terms of reducing incidence of hard or lumpy stools .
The Bristol Stool Form Scale (BS) is validated as a surrogate measure for gastrointestinal transit time, and has been also applied to an evaluation of stool consistency. Subjects compare their stool with the BS chart consisting of seven categories and choose one score which has a nearest analog form. The BS has been widely used in the studies to evaluate changes in stool consistency after dietary intervention using probiotics and/or prebiotics. However, there is a lack of evidence in the validity of BS to yield consistent and reproducible estimates of changes in stool consistency over time. In order to obtain a closer estimate of its change, it would be preferred to use a more directly observable and objective parameter or combination of parameters.
From the above mentioned backgrounds, this study is conducted to validate a new direct method for the measurement of stool consistency, using Texture Analyser: TA.XTExpress Texture Analyser (Stable Micro Systems Ltd.).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen collection | Other | Other: Collection of stool samplesCollection of stool samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities.
- Healthy female or male aged 18 years (inclusive) or older.
- Is willing and able to provide at least 3 stool samples during 2 collection periods of approximately 60 hours, to store the samples in appropriate conditions and to return the samples within the required timeframe.
- Is willing and able to complete a diary during the stool collection periods in order to collect information about form of the stools (based on the Bristol Stool Form Scale classification), bowel habit and sleep habit.
- Understands the Dutch or English language (reading, writing, speaking).
Key exclusion criteria (7 listed)
- Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in this trial.
- Is treated (i.e., currently treated, treated within 1 month before inclusion) for constipation, diarrhoea or any other illness, by use of antibiotics or any other treatment with impact on defecation.
- Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant.
- Is unable to refrain from or anticipates the use of disallowed medications, e.g., antibiotics, laxatives, anti-diarrheal medication.
- Has any history of drug and/or alcohol abuse.
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 |
|---|---|---|
| Collection of stool samplesThe subjects collect stool samples to be used for validation of a new direct measurement of stool consistency. Every stool sample produced during 2 collection periods of approximately 60 hours each have to be collected using the Commode Specimen Collection System (Medline Industries, Inc.). Each collection period starts preferably in the evening (20h00) and ends 3 days later in the morning (08h00). The collected samples must be stored at subject's home in a refrigerator provided by the sponsor until handover to the site staff. | Other | Specimen collection |
Primary outcome
Stool consistency
Time frame: Two stool collection periods of approximately 60 hours each
Stool consistency is measured as force (g) during compression by Texture Analyser. A cylinder probe is put vertically into the object with a constant speed and the force is measured when reaching down to the target (5 mm down from the surface) as an outcome.
9 secondary outcomes
Bristol Stool Form Scale score
Time frame: Two stool collection periods of approximately 60 hours each
Stool water content
Time frame: Two stool collection periods of approximately 60 hours each
Stool mucin
Time frame: Two stool collection periods of approximately 60 hours each
Stool pH
Time frame: Two stool collection periods of approximately 60 hours each
Stool metabolites
Time frame: Two stool collection periods of approximately 60 hours each
Stool microbiota composition
Time frame: Two stool collection periods of approximately 60 hours each
Stool amount
Time frame: Two stool collection periods of approximately 60 hours each
Bowel habit
Time frame: Two stool collection periods of approximately 60 hours each
Sleep habit
Time frame: Two stool collection periods of approximately 60 hours each
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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.
Ignace Demeyer, Dr. principal investigator
Onze-Lieve-Vrouw Hospital Aalst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of stool samples in people with Healthy, run by Yakult Honsha European Research Center, ESV at 1 site in Belgium.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool consistency (time frame: Two stool collection periods of approximately 60 hours each). 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 9 Nov 2017.