Poobao: Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software
Study Details
Study Description
Brief Summary
Collection of a panel of stool images from healthy infants/toddlers for the development of a software
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
To collect at least 200 images per Brussels Infant and Toddler Stool Scale (BITSS) score and at least 200 images of empty (no stool) disposable diapers from healthy infants/toddlers aged 0-24 months for the development of a software
Study Design
Outcome Measures
Primary Outcome Measures
- Total Number of Stool Images Collected [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
Other Outcome Measures
- 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 [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
- An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App [30 days]
An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy infants/toddlers (0-24 months of age at time of enrollment)
-
Informed consent from mother ≥21 years of age
-
In-home access to reliable internet connections; a mobile device suitable for electronic communication; and a device suitable for capturing and transmitting high-quality electronic images as per the PI's discretion
-
Infant/toddler consumes standard, age-appropriate food (breast milk; formula; commercial/homemade baby, table or finger food)
-
Based on the number of stools already acquired per relevant strata at time of enrollment, infant/toddler may or may not be required to regularly produce stools scored as a Score 1, 2, 6 or 7
Exclusion Criteria:
Mothers of Infants/Toddlers:
-
The use of cloth diapers (mothers must commit to using disposable diapers for the duration of the study)
-
Known to have a significant condition (including during pregnancy) that might interfere with the study compliance, as per PI's clinical judgment
-
Deemed likely to be non-compliant with the study protocol, as per PI's clinical judgment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ObvioHealth | Orlando | Florida | United States | 32826 |
| 2 | National University Hospital, Singapore | Singapore | Singapore | 119074 |
Sponsors and Collaborators
- Danone Asia Pacific Holdings Pte, Ltd.
- ObvioHealth
Investigators
- Principal Investigator: Parth Shah, MD, Obvio Health
- Principal Investigator: Seng Hock Quak, MD, National University Hospital, Singapore
Study Documents (Full-Text)
More Information
Publications
- EBB17GC16961
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Mother-infant/Toddler Pairs |
|---|---|
| Arm/Group Description | 96 mother-infant/toddler pairs were enrolled in the study |
| Period Title: Overall Study | |
| STARTED | 96 |
| COMPLETED | 91 |
| NOT COMPLETED | 5 |
Baseline Characteristics
| Arm/Group Title | Mother-infant/Toddler Pairs |
|---|---|
| Arm/Group Description | 96 mother-infant/toddler pairs were enrolled in the study |
| Overall Participants | 96 |
| Age (months) [Mean (Full Range) ] | |
| Infant/Toddler |
13.3
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
30.2
|
| Sex: Female, Male (Count of Participants) | |
| Female |
50
52.1%
|
| Male |
46
47.9%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (participants) [Number] | |
| United States |
96
100%
|
Outcome Measures
| Title | Total Number of Stool Images Collected |
|---|---|
| Description | 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 |
| Time Frame | At least 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mother-infant/Toddler Pairs |
|---|---|
| Arm/Group Description | 96 mother-infant/toddler pairs were enrolled in the study |
| Measure Participants | 96 |
| Number [images] |
2731
|
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Mother-infant/Toddler Pairs |
|---|---|
| Arm/Group Description | 96 mother-infant/toddler pairs were enrolled in the study |
| Measure Participants | 91 |
| Agreement with Mother #1 |
58.0
|
| Agreement with Mother #2 |
48.5
|
| Title | An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App |
|---|---|
| Description | An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| 96 pairs enrolled, 91 completed study, 87 completed the study questionnaire |
| Arm/Group Title | Mother-infant/Toddler Pairs |
|---|---|
| Arm/Group Description | 96 mother-infant/toddler pairs were enrolled in the study |
| Measure Participants | 87 |
| Difficult to score stool pictures: No |
78
81.3%
|
| Difficult to score stool pictures: Yes |
9
9.4%
|
Adverse Events
| Time Frame | no timeframe as no AE/SAE is collected | |
|---|---|---|
| Adverse Event Reporting Description | This is an observation study to collect stool images. no invasive procedures are involved. at risk of SAE/AE is not collected | |
| Arm/Group Title | Mother-infant/Toddler Pairs | |
| Arm/Group Description | 96 mother-infant/toddler pairs were enrolled in the study | |
All Cause Mortality |
||
| Mother-infant/Toddler Pairs | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Serious Adverse Events |
||
| Mother-infant/Toddler Pairs | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
| Mother-infant/Toddler Pairs | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Digital Project Manager |
|---|---|
| Organization | Danone Asia Pacific Holdings |
| Phone | 82281172 |
| jill.wong@danone.com |
- EBB17GC16961