Stool Card in Biliary Atresia

NCT07139717 | Not Yet Recruiting

• 1 other identifier: Stool card in biliary atresia
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stool Color Card; Biliary Atresia

Outcome Measures

Primary Outcomes (1)

• 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.

  First 3 months

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Infants diagnosed with biliary atresia or other cholestatic liver diseases prior to enrollment.
• Infants aged more than 90 days 3-Neonates and infants with indirect hyperbilirubinemia. 4-Those with contraindication to do liver biopsy

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 25681196 BACKGROUND

• Feldman AG, Sokol RJ. Neonatal Cholestasis. Neoreviews. 2013 Feb 1;14(2):10.1542/neo.14-2-e63. doi: 10.1542/neo.14-2-e63.

  PMID: 24244109 BACKGROUND

• Madadi-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.

  PMID: 34842600 BACKGROUND

• Alam 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.

  PMID: 38994513 BACKGROUND

• El-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.

  PMID: 33664005 BACKGROUND

• Schreiber 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.

  PMID: 35207269 BACKGROUND

• Rabbani 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.

  PMID: 34817690 BACKGROUND

MeSH Terms

Conditions

Biliary Atresia

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ahmed Hassan Hamed, Principal Investigator

CONTACT

+201123046138; Ahmed.17289840@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08