Validation of Pediatric Stool ScaleNCT02913950
Pediatric Bristol Stool Scale
An observational study of Validation of Pediatric Stool Scale, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
There is a need to develop a stool scale for baby's and toddlers who are not potty-trained yet. The investigators try to get a uniform and approved Bristol stool scale for children who ware diapers. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Validation of Pediatric Stool Scale
- What is being tested?
- validation of pediatric stool scale
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Sep 2017to 29 May 2018
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data will be collected from a minimum of 50 parents, 25 nurses and 25 primary health care doctors by each participating colleague (listed above), to a maximum of 100
Who may be able to join
- all adults who had children with dapers
Who cannot join
- adults without children
Trial locations and contacts
1 site in 1 country.
About this study
There is a need to develop a stool scale for baby's and toddlers who are not potty-trained yet. The investigators try to get a uniform and approved Bristol stool scale for children who ware diapers.
Read the detailed description
Rationale and background
- There is a need to have an easy way to express the composition aspect of stools. It is known since many years that patients or parents of children just describing what they "see" is very subjective and not reliable for medical use. Because of that need, the Bristol Stool Scale was developed. This is a very easy and reliable way to provide information on stool composition. Seven drawings were made and each drawing corresponds to a precise stool-composition.
- However, this Bristol Stool Scale is developed for adults, or at least for toilet-trained children.
- The group from Amsterdam developed the "Amsterdam Stool Scale", providing additional information on color and volume of the defecations of non-toilet-trained children and infants. However, this scale involved 18 different images, and is too complicated for routine use by parents, nurses and primary health care physicians.
- Because there is "no better", the Bristol Stool Scale is worldwide used to describe the stools of infants and young children. Pediatricians continuously have repeated the idea that "something adapted for young children should be developed". This was recently expressed when a symptom score was developed as awareness tool for cow's milk allergy.
Method so far - what has been done
- The idea is to replace the drawings of adult stools used in the Bristol stool scale with real pictures of real stools of infants and/or young children, not toilet trained, thus wearing diapers.
- The principal investigator asked nurses to take pictures of stools of hospitalized infants and young children during several months. Pictures of hundreds of diapers which contained stools were taken. The principal investigator then selected 28 pictures, in collaboration with the nurses and staff members, best representing the 7 stools described in the Bristol scale.
- These 28 pictures were send out to first core-group (Hania Szajewska (Poland), Annamaria Staiano (Italy), Carmen Ribes-Konickx (Spain), Christophe Dupont (France), Raanan Shamir (Israel)), who selected the seven "best pictures" representing best the original descriptions of the Bristol Stool Scale. These seven pictures were selected with 100 % consensus.
- The principal investigator then mixed the order of the pictures, and send them in combination with the original descriptions of the Bristol Stool Scale to colleague key-opinion leaders, divided over the different parts of the world: Marc Benninga (The Netherlands), Christophe Faure (Canada), Robin Green (South Africa), Badriul Hegar (Indonesia), Roel Lemmens (Belgium), Seksit Osatakul (Thailand), Silvia Salvatore (Italy), Miguel Saps (USA), Mario Vieira (Brazil), Marc Verghote (Belgium), Ioannis Xinias (Greece). Each colleague was asked to put the "best picture" next to each Bristol stool scale descriptions. The result of this was incredibly positive since almost 100 % agreement was reached, if stools are grouped as done in the original Bristol scale: score 1 and 2: constipation score 3 and 4: normal score 5-7: loose stools score 6-7: diarrhea
Next step In a first step, the group of experts will be further enlarged with colleagues from South Africa, Abu Dhabi, Myanmar, Ethiopia and Egypt.
The next step is crucial to reach our goal: demonstrate that parents, nurses and primary health care do interpret the stool-pictures with a high degree of consensus, and this independent whether it is a parent or a health care provider. If the investigators can show that this is true worldwide, a reliable tool to describe the composition of non-toilet trained children has been developed. Since only the illustrations were changed, the investigators called it the "Pediatric Bristol Stool Scale".
Data will be collected from a minimum of 50 parents, 25 nurses and 25 primary health care doctors by each participating colleague (listed above), to a maximum of 100.
Important to realize is that this entire project runs independently from industry, without any funding or financial compensation.
In most countries, the Bristol stool scale is translated into local language since many years, as it used as "golden standard" to describe stool composition. In the rare case, this has not been done, the local investigator will take care of the translation Each investigator will then collect the minimal required number of data, with a maximum of 100. The original data will be collected by the principal investigator, who will do the appropriate statistical analysis.
The goal is to publish a consensus paper with all investigators fulfilling the minimal requirements as co-author and submit the work as an abstract to the next ESPGHAN meeting.
- Conditions
- Validation of Pediatric Stool Scale
- Being tested
- validation of pediatric stool scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validation of pediatric stool scaleOther
validation of pediatric stool scale
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of pediatric Bristol stool scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start6 Sep 2017
- Primary completion29 May 2018
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Validation of Pediatric Stool ScaleStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 100 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
- NCT02913950
- Sponsor's protocol ID
- 2016-281
- Status last verified
- Oct 2018
- First submitted
- 22 Sep 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Vandenplas Y, Szajewska H, Benninga M, Di Lorenzo C, Dupont C, Faure C, Miqdadi M, Osatakul S, Ribes-Konickx C, Saps M, Shamir R, Staiano A; BITSS Study Group. Development of the Brussels Infant and Toddler Stool Scale ('BITSS'): protocol of the study. BMJ Open. 2017 Mar 29;7(3):e014620. doi: 10.1136/bmjopen-2016-014620.
PubMed 28360250
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Bristol Stool Scale
- ClinicalTrials.gov ID
- NCT02913950
- Acronym / sponsor ID
- 2016-281
- Conditions
- Validation of Pediatric Stool Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 26 Sep 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 need to develop a stool scale for baby's and toddlers who are not potty-trained yet. The investigators try to get a uniform and approved Bristol stool scale for children who ware diapers.
Detailed description
Rationale and background
- There is a need to have an easy way to express the composition aspect of stools. It is known since many years that patients or parents of children just describing what they "see" is very subjective and not reliable for medical use. Because of that need, the Bristol Stool Scale was developed. This is a very easy and reliable way to provide information on stool composition. Seven drawings were made and each drawing corresponds to a precise stool-composition.
- However, this Bristol Stool Scale is developed for adults, or at least for toilet-trained children.
- The group from Amsterdam developed the "Amsterdam Stool Scale", providing additional information on color and volume of the defecations of non-toilet-trained children and infants. However, this scale involved 18 different images, and is too complicated for routine use by parents, nurses and primary health care physicians.
- Because there is "no better", the Bristol Stool Scale is worldwide used to describe the stools of infants and young children. Pediatricians continuously have repeated the idea that "something adapted for young children should be developed". This was recently expressed when a symptom score was developed as awareness tool for cow's milk allergy.
Method so far - what has been done
- The idea is to replace the drawings of adult stools used in the Bristol stool scale with real pictures of real stools of infants and/or young children, not toilet trained, thus wearing diapers.
- The principal investigator asked nurses to take pictures of stools of hospitalized infants and young children during several months. Pictures of hundreds of diapers which contained stools were taken. The principal investigator then selected 28 pictures, in collaboration with the nurses and staff members, best representing the 7 stools described in the Bristol scale.
- These 28 pictures were send out to first core-group (Hania Szajewska (Poland), Annamaria Staiano (Italy), Carmen Ribes-Konickx (Spain), Christophe Dupont (France), Raanan Shamir (Israel)), who selected the seven "best pictures" representing best the original descriptions of the Bristol Stool Scale. These seven pictures were selected with 100 % consensus.
- The principal investigator then mixed the order of the pictures, and send them in combination with the original descriptions of the Bristol Stool Scale to colleague key-opinion leaders, divided over the different parts of the world: Marc Benninga (The Netherlands), Christophe Faure (Canada), Robin Green (South Africa), Badriul Hegar (Indonesia), Roel Lemmens (Belgium), Seksit Osatakul (Thailand), Silvia Salvatore (Italy), Miguel Saps (USA), Mario Vieira (Brazil), Marc Verghote (Belgium), Ioannis Xinias (Greece). Each colleague was asked to put the "best picture" next to each Bristol stool scale descriptions. The result of this was incredibly positive since almost 100 % agreement was reached, if stools are grouped as done in the original Bristol scale: score 1 and 2: constipation score 3 and 4: normal score 5-7: loose stools score 6-7: diarrhea
Next step In a first step, the group of experts will be further enlarged with colleagues from South Africa, Abu Dhabi, Myanmar, Ethiopia and Egypt.
The next step is crucial to reach our goal: demonstrate that parents, nurses and primary health care do interpret the stool-pictures with a high degree of consensus, and this independent whether it is a parent or a health care provider. If the investigators can show that this is true worldwide, a reliable tool to describe the composition of non-toilet trained children has been developed. Since only the illustrations were changed, the investigators called it the "Pediatric Bristol Stool Scale".
Data will be collected from a minimum of 50 parents, 25 nurses and 25 primary health care doctors by each participating colleague (listed above), to a maximum of 100.
Important to realize is that this entire project runs independently from industry, without any funding or financial compensation.
In most countries, the Bristol stool scale is translated into local language since many years, as it used as "golden standard" to describe stool composition. In the rare case, this has not been done, the local investigator will take care of the translation Each investigator will then collect the minimal required number of data, with a maximum of 100. The original data will be collected by the principal investigator, who will do the appropriate statistical analysis.
The goal is to publish a consensus paper with all investigators fulfilling the minimal requirements as co-author and submit the work as an abstract to the next ESPGHAN meeting.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected from a minimum of 50 parents, 25 nurses and 25 primary health care doctors by each participating colleague (listed above), to a maximum of 100
Key inclusion criteria (1 listed)
- all adults who had children with dapers
Key exclusion criteria (1 listed)
- adults without children
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 pediatric stool scalevalidation of pediatric stool scale | Other | – |
Primary outcome
validation of pediatric Bristol stool scale
Time frame: 1 year
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 11 Oct 2018.
- Derived from this study: PubMed 28360250Vandenplas Y, Szajewska H, Benninga M, Di Lorenzo C, Dupont C, Faure C, Miqdadi M, Osatakul S, Ribes-Konickx C, Saps M, Shamir R, Staiano A; BITSS Study Group. Development of the Brussels Infant and Toddler Stool Scale ('BITSS'): protocol of the study. BMJ Open. 2017 Mar 29;7(3):e014620. doi: 10.1136/bmjopen-2016-014620.
- Individual participant dataSharing planned: Yes
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 Pediatric Stool Scale, 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 1 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 11 Oct 2018. 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?
validation of pediatric Bristol stool scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913950, which also lists 1 linked publication.
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 11 Oct 2018.