Calprotectin and Gut Disease Study

NCT07112794 | Not Yet Recruiting

• 1 other identifier: 23SH34
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Necrotising enterocolitis (NEC) is a serious gut disease that can develop in infants born with cardiac defects. It causes inflammation and injury to the gut mucosa and may be life-threatening.1 The aetiology of NEC in cardiac infants is multifactorial, associated with poor cardiac outflow and poorly oxygenated systemic circulation, resulting in suboptimal blood flow to the intestines.2 Making an accurate and timely diagnosis of NEC is a significant clinical challenge.3 The clinical presentation of NEC is difficult to identify correctly in the early stages of the disease. Of concern, infants who are diagnosed with NEC at a later stage have worse disease.4 Due to the potentially life-threatening effects of NEC, clinicians who suspect a baby has NEC but are unable to confirm it, temporarily manage infants as if they have NEC as a precautionary measure. This leads to infants without NEC having their milk feeds stopped for several days and being given unnecessary antibiotics. Compared to infants with confirmed NEC, the care of infants with suspected NEC is widely variable in terms of antibiotic regimen chosen, length of antibiotic treatment, and length of time nil-by-mouth - all these variabilities may adversely contribute to the length of hospital stay.5 We want to study a method to improve the accuracy of diagnosing NEC. We want to measure a protein marker found in babies' stools that, if combined with currently available tests (clinical features, lab tests and abdominal X-rays), 6,7 may improve the timeliness and accuracy of making a NEC diagnosis, crucially at an early stage of gut disease. The protein marker is called calprotectin and monitoring levels in a baby's stools before and after heart surgery may help us to understand its relationship to NEC. Calprotectin is a biomarker that is released by white blood cells and is present in the gut when it is inflamed and can be measured in stool.8 The amount of calprotectin in the stool may indicate the level of gut inflammation and the presence of NEC in infants with heart defects.9 The addition of calprotectin measurement to the current routine parameters (clinical features, lab tests and abdominal X-rays) may improve the timeliness and accuracy of diagnosing NEC in infants with cardiac defects, hence improving their care pathway and outcomes.

Conditions

Congenital Heart Disease

Keywords

necrotising enterocolitis; Faecal Calprotectin

Outcome Measures

Primary Outcomes (1)

• Faecal calprotectin

  Sensitivity and specificity of faecal calprotectin as a biomarker to detect true NEC cases in the study population based on gold standard evaluation

  2 years

Study Arms (1)

cardiac

Infants aged from birth up to 3 months old, of any gestational age who require admission to a specialist cardiac centre for treatment of major congenital heart disease.

Eligibility Criteria

• Age: 0 Months - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants with congenital heart disease Specialist children's hospitals undertaking cardiac surgery in England: 1. Great Ormond Street Children's Hospital 2. Alder Hey 3. Birmingham 4. Southampton hospitals

You may qualify if:

• Infants aged from birth up to 3 months old, of any gestational age who require admission to a specialist cardiac centre for treatment of major congenital heart disease.
• Included patients are those who are judged as likely to require early cardiac surgery or interventional catheterisation, including babies who are treated with invasive medical therapies of respiratory support or intravenous vasoactive medications and their pathway will include a cardiac intervention of any type.

You may not qualify if:

• Patients will be excluded if they are older than 3 months, do not have major heart disease and do have any gastrointestinal abnormality, including gastroschisis or imperforate anus.
• Also, patients with neutropenia will be excluded since calprotectin is not activated when there is neutropenia.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• University Hospital Southampton NHS Foundation Trust: collaborator
• Birmingham Children's Hospital: collaborator
• Alder Hey Children's NHS Foundation Trust: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples will be collected and stored in plastic test tube containers and directly sent to the hospital clinical laboratory. The calprotectin will be measured using the commercially available enzyme-linked immunosorbent assay (ELISA) kit of Bühlmann Laboratories AG (Switzerland) according to the manufacturer's instructions. In brief, monoclonal capture antibodies highly specific to the calprotectin heterodimeric and polymeric complex are coated on the microliter plate when calprotectin was assayed in a single measurement using DS2 automated ELISA processing system (extended range 30-1,800 μg/g).

MeSH Terms

Conditions

Heart Defects, Congenital; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Graeme O'Connor, PHD

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graeme O'Connor, PhD

CONTACT

+447958543828; graeme.o'connor@gosh.nhs.uk

katherine Brown, MD PHD

CONTACT

+44204059200; Katherine.Brown@gosh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share