Evaluating causes of isolated rectal bleeding in newborns
Official title: Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
Run by Centre Hospitalier Universitaire de Nice · NCT06088537 · Data updated 2026-11-12
This study is trying to find out how often cow's milk protein allergies cause rectal bleeding in newborns who are hospitalized for this issue.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 28 Days |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes-Mritimes) |
| Status | Recruiting |
| Started | January 24, 2024 |
| Main results expected | July 24, 2027 |
| Study ends | July 24, 2027 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT06088537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are newborns hospitalized with isolated rectal bleeding who are less than 28 days old or 44 weeks corrected age.
✕Probably not a fit
Patients with severe underlying conditions such as ulcerative enterocolitis or congenital digestive malformations will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational pilot study aims to assess the frequency of cow's milk protein allergic proctocolitis in newborns who are hospitalized with isolated rectal bleeding at the University Hospital of Nice. It includes all newborns up to 28 days corrected age or 44 weeks corrected age who present with this condition, ensuring that they do not exhibit any severe symptoms. Data will be collected during hospitalization, including clinical examinations and follow-up assessments to determine the underlying causes of rectal bleeding. The study is non-interventional, focusing solely on current practices and outcomes.
Why it matters
Potential benefit: If successful, this study could improve the understanding and management of allergic proctocolitis in newborns, leading to better treatment strategies.
How similar studies have gone: While this study focuses on a specific population, similar observational studies have shown promise in identifying causes of gastrointestinal issues in newborns.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia; 2. Affiliated to social security ; 3. Presenting isolated rectorrhagia defined as rectorrhagia without hematemesis/ repeated vomiting/ tense or distended abdomen/ apathy/ apnea/ bradycardia or signs of severity (tachycardia, desaturation, poor coloration); 4. After obtaining the biological mother's non-objection; Exclusion Criteria: 1. All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery; 2. Opposition to participation in research involving the human person.
Where it's running
-
CHU Nice - Hôpital Archet 2
Nice, Alpes-Mritimes, France Recruiting
Study contacts
- Study coordinator: Bérengère FRANCOIS-GARRET, Doctor
- Email: francois-garret.b@chu-nice.fr
- Phone: 492036365
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.