Validation of BITTSNCT03705689
Validation BITSS Brussels Infant Stool Scale
An observational study of Validation of BITTS, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
validation of stool scale in toddlers Read more about this study
- Who is it for?
- Ages 0 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation of BITTS
- What is being tested?
- validation of Bitts
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2018to 1 Nov 2019
- Phase
- Observational
- 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 0 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: all children who are non-toilet trained
Who may be able to join
None listed.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
validation of stool scale in toddlers
Read the detailed description
objective : the Bristol stool form scale (BSFS) is inadequate for non-toilet trained children.
The Brussels Infant and Toddler Stool Scale (BITTS) was developed, consisting of 7 photograps of diapers containing stools of infants and toddlers. We aimed to evaluate inter-observer reliability of stool consistency assessment among parents, nurses and medical doctors using the BITTS.
Method :
In this multicenter cross-sectional study (2016-2017), Bitts photograps were rated according to the BSFS. The reliability of the BITTS was evaluated using the overall proportion of perfect agreement and the linearly weighted K statistic.
What is known :
- reliable assessment of stool consistency is important for evaluating children's defecation pattern and diagnosing gastrointestinal disorders.
- the reliability of the Bristol Stool Form Scale, developed for adults, has been debated for young children who are non-toilet trained and wear diapers
To get validation of the BITTS :
- a non-toilet trained child makes stool in diaper
- caregiver scores the aspect of the stool according to the BITTS
- caregiver takes a picture of the diaper
- after 1 monts she rescores the picture according to the BITTS
- Conditions
- Validation of BITTS
- Being tested
- validation of Bitts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validation of BittsOther
No intervention, observation of photographs of stool
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the inter-observer reliability of stool consistency
stool of a non-toilet trained child wuk be scired by a caregiver according to the BITTS. Then the caregiver takes a picter of this diaper with stool. After 1 month she rescores the picter according to BITTS
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Nov 2018
- Primary completion30 Apr 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation of BITTSStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvan Vandenplas, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705689
- Sponsor's protocol ID
- 2018-365
- Status last verified
- Nov 2020
- First submitted
- 8 Oct 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation BITSS Brussels Infant Stool Scale
- ClinicalTrials.gov ID
- NCT03705689
- Acronym / sponsor ID
- 2018-365
- Conditions
- Validation of BITTS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 15 Oct 2018 (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.
validation of stool scale in toddlers
Detailed description
objective : the Bristol stool form scale (BSFS) is inadequate for non-toilet trained children.
The Brussels Infant and Toddler Stool Scale (BITTS) was developed, consisting of 7 photograps of diapers containing stools of infants and toddlers. We aimed to evaluate inter-observer reliability of stool consistency assessment among parents, nurses and medical doctors using the BITTS.
Method :
In this multicenter cross-sectional study (2016-2017), Bitts photograps were rated according to the BSFS. The reliability of the BITTS was evaluated using the overall proportion of perfect agreement and the linearly weighted K statistic.
What is known :
- reliable assessment of stool consistency is important for evaluating children's defecation pattern and diagnosing gastrointestinal disorders.
- the reliability of the Bristol Stool Form Scale, developed for adults, has been debated for young children who are non-toilet trained and wear diapers
To get validation of the BITTS :
- a non-toilet trained child makes stool in diaper
- caregiver scores the aspect of the stool according to the BITTS
- caregiver takes a picture of the diaper
- after 1 monts she rescores the picture according to the BITTS
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- all children who are non-toilet trained
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| validation of BittsNo intervention, observation of photographs of stool | Other | – |
Primary outcome
to evaluate the inter-observer reliability of stool consistency
Time frame: 6months
stool of a non-toilet trained child wuk be scired by a caregiver according to the BITTS. Then the caregiver takes a picter of this diaper with stool. After 1 month she rescores the picter according to BITTS
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 5 Nov 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation of BITTS, run by Universitair Ziekenhuis Brussel 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 0 inclusion and 1 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 5 Nov 2020. 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?
to evaluate the inter-observer reliability of stool consistency (time frame: 6months). 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 5 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.