Stool Color CardNCT07139717
Stool Card in Biliary Atresia
An observational study of Stool Color Card and Biliary Atresia, run by Assiut University.
Trial summary
To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilitating timely surgical intervention. Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Stool Color Card, Biliary Atresia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Study population: The study population will consist of newborn infants screened using the stool color card during the first six months of life. Participants will be recruited from pediatric outpatient clinics and neonatal follow-up units, as well as infants admitted with suspected liver disease at [Name of Hospital/Region]. Both healthy infants and those later diagnosed with biliary atresia will be included to evaluate the diagnostic accuracy of the stool color card.
Who may be able to join
- Neonates and infants aged 1-90 days old.
- Neonates and infants with direct (conjugated) hyperbilirubinemia (Conjugated hyperbilirubinemia is generally defined as a conjugated or direct bilirubin level greater than 1 mg/dL when the total bilirubin is less than 5 mg/dL or more than 20% of the total bilirubin if the total bilirubin is greater than 5 mg/dL) [12]
- No contraindication for liver biopsy as considered the gold standard for diagnosis of biliary atresia e.g. coagulopathy.
Who cannot join
- 1 - Infants diagnosed with biliary atresia or other cholestatic liver diseases prior to enrollment.
- 2-Infants aged more than 90 days 3-Neonates and infants with indirect hyperbilirubinemia. 4-Those with contraindication to do liver biopsy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effectiveness of Stool Color Card in the Early Detection of Biliary Atresia: A Prospective Study.
To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilitating timely surgical intervention.
Read the detailed description
Biliary atresia (BA) is a rare but life-threatening liver disorder that affects infants, characterized by the progressive inflammation and fibrosis of the bile ducts, leading to biliary obstruction [1].
Early diagnosis and intervention are crucial - ideally before 60 days of age - as BA is a leading cause of liver transplantation in children if not diagnosed and treated promptly [2]. The traditional method of diagnosis involves the identification of clinical signs like jaundice and abnormal liver function tests, but this approach can delay the diagnosis, leading to irreversible liver damage. As a result, early detection is essential to improve outcomes and prevent the need for a liver transplant [3].
The stool color card (SCC) is a diagnostic tool that has gained significant attention in recent years as a non-invasive method for the early detection of biliary atresia [4]. Newborns with biliary atresia typically exhibit pale stools due to a lack of bile secretion [5].
The stool color card provides a simple way for parents or healthcare professionals to monitor changes in the stool color in newborns, providing an early indicator of potential biliary atresia [6,7]. The card features a range of colors that correspond to the different stages of stool color, allowing for easy comparison and identification of abnormal stool [8-11].
Despite the availability of SCCs, their effectiveness in routine screening programs remains understudied. There is a need to evaluate the utility of SCCs in improving early diagnosis rates of BA.
- Conditions
- Stool Color Card, Biliary Atresia
- Medical subject headings
- Biliary Atresia
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Stool Color Card in Early Detection of Biliary Atresia
Diagnostic accuracy of the stool color card for early detection of biliary atresia (BA). Accuracy will be evaluated by sensitivity (proportion of BA cases detected), specificity (proportion of healthy infants correctly identified as not having BA), positive predictive value (PPV), and negative predictive value (NPV), compared to the reference standard of final diagnosis confirmed by imaging or surgery.
Measured: First 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stool Color CardStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Hamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139717
- Sponsor's protocol ID
- Stool card in biliary atresia
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gu YH, Yokoyama K, Mizuta K, Tsuchioka T, Kudo T, Sasaki H, Nio M, Tang J, Ohkubo T, Matsui A. Stool color card screening for early detection of biliary atresia and long-term native liver survival: a 19-year cohort study in Japan. J Pediatr. 2015 Apr;166(4):897-902.e1. doi: 10.1016/j.jpeds.2014.12.063. Epub 2015 Feb 11.
PubMed 25681196Feldman AG, Sokol RJ. Neonatal Cholestasis. Neoreviews. 2013 Feb 1;14(2):10.1542/neo.14-2-e63. doi: 10.1542/neo.14-2-e63.
PubMed 24244109Madadi-Sanjani O, Kuebler JF, Uecker M, Pfister ED, Baumann U, Kunze-Hullmann B, Blaser J, Buck T, Petersen C. Province-Wide Stool Color Card Screening for Biliary Atresia in Lower-Saxony: Experiences with Passive Distribution Strategies and Results. Int J Neonatal Screen. 2021 Nov 4;7(4):75. doi: 10.3390/ijns7040075.
PubMed 34842600Alam R, Nahid KL, Faruk MO, Rasna EH, Rukunuzzaman M. Use of stool color card as screening tool for biliary atresia in resource-constraint country. Gastroenterol Hepatol Bed Bench. 2024;17(2):146-150. doi: 10.22037/ghfbb.v17i2.2931.
PubMed 38994513El-Shabrawi MH, Baroudy SR, Hassanin FS, Farag AE. A pilot study of the value of a stool color card as a diagnostic tool for extrahepatic biliary atresia at a single tertiary referral center in a low/middle income country. Arab J Gastroenterol. 2021 Mar;22(1):61-65. doi: 10.1016/j.ajg.2020.12.004. Epub 2021 Mar 2.
PubMed 33664005Schreiber RA, Harpavat S, Hulscher JBF, Wildhaber BE. Biliary Atresia in 2021: Epidemiology, Screening and Public Policy. J Clin Med. 2022 Feb 14;11(4):999. doi: 10.3390/jcm11040999.
PubMed 35207269Rabbani T, Guthery SL, Himes R, Shneider BL, Harpavat S. Newborn Screening for Biliary Atresia: a Review of Current Methods. Curr Gastroenterol Rep. 2021 Nov 24;23(12):28. doi: 10.1007/s11894-021-00825-2.
PubMed 34817690
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Stool Color Card in the Early Detection of Biliary Atresia: A Prospective Study.
- ClinicalTrials.gov ID
- NCT07139717
- Acronym / sponsor ID
- Stool card in biliary atresia
- Conditions
- Stool Color Card, Biliary Atresia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effectiveness of using a stool color card as a non-invasive screening tool for the early detection of biliary atresia, with the objective of improving early diagnosis rates and facilitating timely surgical intervention.
Detailed description
Biliary atresia (BA) is a rare but life-threatening liver disorder that affects infants, characterized by the progressive inflammation and fibrosis of the bile ducts, leading to biliary obstruction [1].
Early diagnosis and intervention are crucial - ideally before 60 days of age - as BA is a leading cause of liver transplantation in children if not diagnosed and treated promptly [2]. The traditional method of diagnosis involves the identification of clinical signs like jaundice and abnormal liver function tests, but this approach can delay the diagnosis, leading to irreversible liver damage. As a result, early detection is essential to improve outcomes and prevent the need for a liver transplant [3].
The stool color card (SCC) is a diagnostic tool that has gained significant attention in recent years as a non-invasive method for the early detection of biliary atresia [4]. Newborns with biliary atresia typically exhibit pale stools due to a lack of bile secretion [5].
The stool color card provides a simple way for parents or healthcare professionals to monitor changes in the stool color in newborns, providing an early indicator of potential biliary atresia [6,7]. The card features a range of colors that correspond to the different stages of stool color, allowing for easy comparison and identification of abnormal stool [8-11].
Despite the availability of SCCs, their effectiveness in routine screening programs remains understudied. There is a need to evaluate the utility of SCCs in improving early diagnosis rates of BA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will consist of newborn infants screened using the stool color card during the first six months of life. Participants will be recruited from pediatric outpatient clinics and neonatal follow-up units, as well as infants admitted with suspected liver disease at [Name of Hospital/Region]. Both healthy infants and those later diagnosed with biliary atresia will be included to evaluate the diagnostic accuracy of the stool color card.
Key inclusion criteria (3 listed)
- Neonates and infants aged 1-90 days old.
- Neonates and infants with direct (conjugated) hyperbilirubinemia (Conjugated hyperbilirubinemia is generally defined as a conjugated or direct bilirubin level greater than 1 mg/dL when the total bilirubin is less than 5 mg/dL or more than 20% of the total bilirubin if the total bilirubin is greater than 5 mg/dL) [12]
- No contraindication for liver biopsy as considered the gold standard for diagnosis of biliary atresia e.g. coagulopathy.
Key exclusion criteria (2 listed)
- 1 - Infants diagnosed with biliary atresia or other cholestatic liver diseases prior to enrollment.
- 2-Infants aged more than 90 days 3-Neonates and infants with indirect hyperbilirubinemia. 4-Those with contraindication to do liver biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of Stool Color Card in Early Detection of Biliary Atresia
Time frame: First 3 months
Diagnostic accuracy of the stool color card for early detection of biliary atresia (BA). Accuracy will be evaluated by sensitivity (proportion of BA cases detected), specificity (proportion of healthy infants correctly identified as not having BA), positive predictive value (PPV), and negative predictive value (NPV), compared to the reference standard of final diagnosis confirmed by imaging or surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Results publication: PubMed 25681196Gu YH, Yokoyama K, Mizuta K, Tsuchioka T, Kudo T, Sasaki H, Nio M, Tang J, Ohkubo T, Matsui A. Stool color card screening for early detection of biliary atresia and long-term native liver survival: a 19-year cohort study in Japan. J Pediatr. 2015 Apr;166(4):897-902.e1. doi: 10.1016/j.jpeds.2014.12.063. Epub 2015 Feb 11.
- Results publication: PubMed 24244109Feldman AG, Sokol RJ. Neonatal Cholestasis. Neoreviews. 2013 Feb 1;14(2):10.1542/neo.14-2-e63. doi: 10.1542/neo.14-2-e63.
- Results publication: PubMed 34842600Madadi-Sanjani O, Kuebler JF, Uecker M, Pfister ED, Baumann U, Kunze-Hullmann B, Blaser J, Buck T, Petersen C. Province-Wide Stool Color Card Screening for Biliary Atresia in Lower-Saxony: Experiences with Passive Distribution Strategies and Results. Int J Neonatal Screen. 2021 Nov 4;7(4):75. doi: 10.3390/ijns7040075.
- Results publication: PubMed 38994513Alam R, Nahid KL, Faruk MO, Rasna EH, Rukunuzzaman M. Use of stool color card as screening tool for biliary atresia in resource-constraint country. Gastroenterol Hepatol Bed Bench. 2024;17(2):146-150. doi: 10.22037/ghfbb.v17i2.2931.
- Results publication: PubMed 33664005El-Shabrawi MH, Baroudy SR, Hassanin FS, Farag AE. A pilot study of the value of a stool color card as a diagnostic tool for extrahepatic biliary atresia at a single tertiary referral center in a low/middle income country. Arab J Gastroenterol. 2021 Mar;22(1):61-65. doi: 10.1016/j.ajg.2020.12.004. Epub 2021 Mar 2.
- Results publication: PubMed 35207269Schreiber RA, Harpavat S, Hulscher JBF, Wildhaber BE. Biliary Atresia in 2021: Epidemiology, Screening and Public Policy. J Clin Med. 2022 Feb 14;11(4):999. doi: 10.3390/jcm11040999.
- Results publication: PubMed 34817690Rabbani T, Guthery SL, Himes R, Shneider BL, Harpavat S. Newborn Screening for Biliary Atresia: a Review of Current Methods. Curr Gastroenterol Rep. 2021 Nov 24;23(12):28. doi: 10.1007/s11894-021-00825-2.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stool Color Card and Biliary Atresia, run by Assiut University.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hassan Hamed, Principal Investigator (+201123046138, Ahmed.17289840@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Stool Color Card in Early Detection of Biliary Atresia (time frame: First 3 months). 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 NCT07139717, which also lists 7 linked publications.
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 24 Aug 2025.