HealthyPoobaoNCT03402555

Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software

An observational study of Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.

Completed

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

Trial summary

Collection of a panel of stool images from healthy infants/toddlers for the development of a software Read more about this study

Who is it for?: Ages Up to 24 monthsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Stool pattern
How many people: 96 participants
Where: 2 sitesin 2 countries
Study dates: 31 May 2018to 6 Mar 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 24 months
All sexes
Healthy volunteers accepted
Child

Study population: Healthy subjects aged 0-24 months

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

ObvioHealth
Orlando, Florida, 32826

Other trials in United States

Singapore1 site

National University Hospital, Singapore
Singapore, 119074

Other trials in Singapore

About this study

Official title: Observational Study: Image Collection of Infant/Toddler Stools for Danone Software Development

Collection of a panel of stool images from healthy infants/toddlers for the development of a software

Read the 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

Conditions: Healthy
Being tested: Stool pattern

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stool patternOther
Collection of stool images

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Number of Stool Images Collected
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
Measured: At least 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 20186 Mar 2019

First posted18 Jan 2018
Study start31 May 2018
Primary completion17 Dec 2018
Study completion6 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Cohort
Time perspective: Prospective
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03402555
Sponsor's protocol ID: EBB17GC16961
Acronym: Poobao
Status last verified: Aug 2020
First submitted: 11 Jan 2018
Last updated: 7 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study: Image Collection of Infant/Toddler Stools for Danone Software Development
ClinicalTrials.gov ID: NCT03402555
Acronym / sponsor ID: Poobao / EBB17GC16961
Conditions: Healthy
Study type: Observational
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
Collaborators: ObvioHealth
Study start: 31 May 2018 (actual)
Primary completion: 17 Dec 2018 (actual)
Study completion: 6 Mar 2019 (actual)
First posted: 18 Jan 2018 (actual)
Results: Posted 7 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Collection of a panel of stool images from healthy infants/toddlers for the development of a software

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: Up to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Healthy subjects aged 0-24 months

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stool patternCollection of stool images	Other	–

Primary outcome

Total Number of Stool Images Collected
Time frame: 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

Results and safety

Results posted to the registry on 7 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mother-infant/Toddler Pairs	96	91

Primary outcome: Total Number of Stool Images Collected

Time frame: At least 30 days. Number. Unit: images

Measure	Mother-infant/Toddler Pairs n = 96
Value	2731

Adverse events

Time frame: no timeframe as no AE/SAE is collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mother-infant/Toddler Pairs	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28360250Vandenplas 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Parth Shah, MD principal investigator

Obvio Health

Seng Hock Quak, MD principal investigator

National University Hospital, Singapore

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.

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 5 inclusion and 4 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 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Singapore. 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?

Yes. Results are posted in the registry (first posted 7 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Number of Stool Images Collected (time frame: At least 30 days). 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 NCT03402555, 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 7 Aug 2020.