Trial Outcomes & Findings for Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software (NCT NCT03402555)

NCT ID: NCT03402555

Last Updated: 2020-08-07

Results Overview

Creation of a database containing at least 1600 pictures of individual diapers: * 200 images of diapers with stool per each score (BITSS types 1 to 7) * 200 images of empty (no stool) disposable diapers

• Recruitment status: COMPLETED
• Target enrollment: 96 participants
• Primary outcome timeframe: At least 30 days
• Results posted on: 2020-08-07

Participant Flow

The mother was to complete an eQuestionnaire for eligibility confirmation and upload 3 separate test images of her infant/toddler's stool via ClaimIt within a window of 10 days. The mother and infant/toddler were enrolled if the test images were successfully uploaded and if they met all inclusion criteria and none of the exclusion criteria.

Participant milestones

Measure	Mother-infant/Toddler Pairs 96 mother-infant/toddler pairs were enrolled in the study
Overall Study STARTED	96
Overall Study COMPLETED	91
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Mother-infant/Toddler Pairs n=96 Participants 96 mother-infant/toddler pairs were enrolled in the study
Age, Continuous Infant/Toddler	13.3 months n=96 Participants
Age, Continuous	30.2 years n=96 Participants
Sex: Female, Male Female	50 Participants n=96 Participants
Sex: Female, Male Male	46 Participants n=96 Participants
Region of Enrollment United States	96 participants n=96 Participants

PRIMARY outcome

Timeframe: At least 30 days

Creation of a database containing at least 1600 pictures of individual diapers:

• 200 images of diapers with stool per each score (BITSS types 1 to 7)
• 200 images of empty (no stool) disposable diapers

Outcome measures

Measure	Mother-infant/Toddler Pairs n=96 Participants 96 mother-infant/toddler pairs were enrolled in the study
Total Number of Stool Images Collected	2731 images

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

A comparison of the stool consistency scores from the mothers on-study to re-scores from two mothers (not enrolled on study, Mother #1 and Mother #2) based only on the uploaded images

Outcome measures

Measure	Mother-infant/Toddler Pairs n=91 Participants 96 mother-infant/toddler pairs were enrolled in the study
A Comparison of the Stool Consistency Scores From the Mothers On-study to Re-scores From Mothers (Not Enrolled on Study) Based Only on the Uploaded Images Agreement with Mother #1	58.0 percentage of agreement
A Comparison of the Stool Consistency Scores From the Mothers On-study to Re-scores From Mothers (Not Enrolled on Study) Based Only on the Uploaded Images Agreement with Mother #2	48.5 percentage of agreement

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: 96 pairs enrolled, 91 completed study, 87 completed the study questionnaire

An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire

Outcome measures

Measure	Mother-infant/Toddler Pairs n=87 Participants 96 mother-infant/toddler pairs were enrolled in the study
An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App Difficult to score stool pictures: No	78 Participants
An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App Difficult to score stool pictures: Yes	9 Participants

Adverse Events

Mother-infant/Toddler Pairs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Digital Project Manager

Danone Asia Pacific Holdings

Phone: 82281172

Email: jill.wong@danone.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place