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NCT Number: NCT07139717

Stool Card in Biliary Atresia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Hassan Hamed, Principal Investigator

CONTACT

[email protected]

+201123046138

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Evaluation of the Effectiveness of Stool Color Card in the Early Detection of Biliary Atresia: A Prospective Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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