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CompletedNCT03705689Updated Nov 5, 2020

Validation BITSS Brussels Infant Stool Scale

An observational study in Validation of BITTS, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged 0 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Universitair Ziekenhuis Brussel · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
0 Years to 5 Years
Sex
All
01

Study summary

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
02

Conditions studied

  • Validation of BITTS
03

In context

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

all children who are non-toilet trained

Eligibility criteria

Inclusion Criteria:pictures of diapers with stool of all childeren who are non-toilet trained

-

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (actual)
Patient registry
No

Interventions

  • Othervalidation of Bitts

    No intervention, observation of photographs of stool

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6months

07

Study locations

1 site
  • UZ Brussel
    Brussels, 1090, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03705689
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Yvan Vandenplas (head of Clinic, Universitair Ziekenhuis Brussel) — Principal investigator
First posted
Oct 15, 2018
Start date
Nov 1, 2018
Primary completion
Apr 30, 2019
Completion
Nov 1, 2019
Last update
Nov 5, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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