Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02913950 |
| Other study ID # |
2016-281 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 6, 2017 |
| Est. completion date |
May 29, 2018 |
Study information
| Verified date |
October 2018 |
| Source |
Universitair Ziekenhuis Brussel |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
