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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • UZ Brussel

    Brussels, 1090

Other trials in Belgium

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

  1. 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.
  2. However, this Bristol Stool Scale is developed for adults, or at least for toilet-trained children.
  3. 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.
  4. 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

  1. 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.
  2. 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.
  3. 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.
  4. 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.

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.

  1. 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.

  1. First posted26 Sep 2016 (estimated)
  2. Study start6 Sep 2017
  3. Primary completion29 May 2018
  4. Study completion29 May 2018

Resources

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)
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

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.

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