Isolated Rectal BleedingsCOLONNCT06088537
Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
An observational study of Isolated Rectal Bleedings, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Isolated Rectal Bleedings
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2024to 24 Jul 2027
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia.
Who may be able to join
- All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia;
- Affiliated to social security ;
- 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);
- After obtaining the biological mother's non-objection;
Who cannot join
- All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
- Opposition to participation in research involving the human person.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emma LAISSAC contact
France1 site, 1 recruiting
- Recruiting
CHU Nice - Hôpital Archet 2
Nice, Alpes-Mritimes, 06000
Bérengère FRANCOIS-GARRET, MD, 0492036365 ext. +33, francois-garret.b@chu-nice.fr
Emma LAISSAC, mailto:laissac.emma@gmail.com
About this study
Prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding.
Read the detailed description
Inclusion of all newborns in the neonatal medicine department at Nice University Hospital with isolated rectal bleeding.
A note of information and non-opposition will be presented and given to the biological mother. She has the right to object to this study, on her own initiative, at any time.
Collection of data relating to the newborn during hospitalization, the results of the clinical examination and the systematic check-up carried out in accordance with standard practice, and data at discharge.
Follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cow's milk proteins.
Prospective observational study of current practices without any intervention.
- Conditions
- Isolated Rectal Bleedings
- Keywords
- allergic proctocolitis, neonatal colitis transient, cow's milk protein allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia.
The main objective of this study is to determine the number of newborns presenting real allergic proctocolitis to cow's milk protein among all newborns hospitalised in neonatal medicine who presented with isolated rectal bleeding in order to determine the frequency of this pathology.
If rectal bleeding disappears when cow's milk proteins are eliminated and reappears when cow's milk proteins are reintroduced, the diagnosis of allergic proctocolitis to cow's milk proteins will be confirmed.
In other cases, newborns will be considered to have had transient neonatal colitis.
Then this study will determine the frequency of these two diseases in the population study.
Measured: 3 years
Secondary outcomes (1)
Identify risk factors for developing transient neonatal colitis.
To determine these risk factors, the study will compare the characteristics of newborns with allergic protocolitis to cow's milk proteins with those of newborns with transient neonatal colitis.
The parameters compared between the two groups will be as follows: gestational age at birth, route of delivery, antibiotic therapy prior to rectal bleeding, type of diet (mother's milk or artificial milk) family history of allergy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start24 Jan 2024
- Primary completion24 Jul 2027 (estimated)
- Study completion24 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Rectal BleedingsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088537
- Sponsor's protocol ID
- 23-PP-05
- Acronym
- COLON
- Status last verified
- Jan 2026
- First submitted
- 5 Oct 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
- ClinicalTrials.gov ID
- NCT06088537
- Acronym / sponsor ID
- COLON / 23-PP-05
- Conditions
- Isolated Rectal Bleedings
- Keywords
- allergic proctocolitis, neonatal colitis transient, cow's milk protein allergic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 24 Jul 2027 (estimated)
- Study completion
- 24 Jul 2027 (estimated)
- First posted
- 18 Oct 2023 (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.
Prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding.
Detailed description
Inclusion of all newborns in the neonatal medicine department at Nice University Hospital with isolated rectal bleeding.
A note of information and non-opposition will be presented and given to the biological mother. She has the right to object to this study, on her own initiative, at any time.
Collection of data relating to the newborn during hospitalization, the results of the clinical examination and the systematic check-up carried out in accordance with standard practice, and data at discharge.
Follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cow's milk proteins.
Prospective observational study of current practices without any intervention.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia.
Key inclusion criteria (4 listed)
- All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia;
- Affiliated to social security ;
- 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);
- After obtaining the biological mother's non-objection;
Key exclusion criteria (2 listed)
- All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
- Opposition to participation in research involving the human person.
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
Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia.
Time frame: 3 years
The main objective of this study is to determine the number of newborns presenting real allergic proctocolitis to cow's milk protein among all newborns hospitalised in neonatal medicine who presented with isolated rectal bleeding in order to determine the frequency of this pathology. If rectal bleeding disappears when cow's milk proteins are eliminated and reappears when cow's milk proteins are reintroduced, the diagnosis of allergic proctocolitis to cow's milk proteins will be confirmed. In other cases, newborns will be considered to have had transient neonatal colitis. Then this study will determine the frequency of these two diseases in the population study.
1 secondary outcome
Identify risk factors for developing transient neonatal colitis.
Time frame: 3 years
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 23 Jan 2026.
- Individual participant dataSharing planned: No
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.
Emma LAISSAC contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolated Rectal Bleedings, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 4 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Bérengère FRANCOIS-GARRET, Doctor (492036365 ext. +33, francois-garret.b@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.