Enteropathy, Necrotizing EnterocolitisCALPROPREMANCT02010268
Use of Faecal Calprotectin to Predict Enteropathy of the Preterm Neonates
A study testing Collection of stool samples in people with Enteropathy, Necrotizing Enterocolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates. Read more about this study
- Who is it for?
- Ages Up to 33 months
- Conditions the study is for
- Enteropathy, Necrotizing Enterocolitis
- What is being tested?
- Collection of stool samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2013to 22 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 33 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants prematurely born at a gestational age of 33 weeks or less (or before the 7th month of pregnancy).
- Patient whose parents or holders of parental authority signed an informed consent.
Who cannot join
- Patient with a malformation.
- Lack of signature of the consent by parents or holders of parental authority.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.
This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.
Read the detailed description
Enteropathy and necrotizing enterocolitis (NEC) are digestive emergencies in premature neonates which represent a major concern for the vital prognosis. It is therefore important to propose a tool for early diagnosis of these intestinal complications in order to avoid extended interruptions of enteral feeding at a period of life where growth (and digestive maturation) is in the foreground. Currently, the diagnosis of digestive impairment is based on classical clinical, biological (CRP, procalcitonin, fecal calprotectin, NFS) and radiological (abdomen without preparation) approaches, which induce on one hand a prolonged interruption of enteral feeding sometimes useless and even harmful for the intestinal maturation and, secondly, the establishment of a parenteral nutrition which is not risk-free. The study propose to dose the fecal calprotectin, a non-invasive marker of digestive inflammation, in order to validate the threshold decision proposed in a pilot study (350 µg/g of feces). Measurement of fecal calprotectin levels will be used as an integrated tool to build a powerful screening score combined to the usual parameters used in routine care for the diagnosis of and enteropathy and necrotizing enterocolitis (NEC) in premature neonates. A cohort of preterm infants born at a gestational age of 33 weeks or less will be included from birth. A stool sample will be collected from the diaper once a week, from birth until discharge from the hospital, and every day during gastrointestinal events (interruption of enteral feeding over 48 hours). The study will evaluate the performance of the rapid assay of fecal calprotectin by quantitative immunochromatography compared to the reference method by enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Enteropathy, Necrotizing Enterocolitis
- Being tested
- Collection of stool samples
- Keywords
- Faecal calprotectin, Feces, Preterm neonates, Enterocolitis, Enteropathy, Necrotizing
- Medical subject headings
- Intestinal Diseases, Enterocolitis, Necrotizing, Enterocolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of stool samplesOther
A stool sample will be collected once a week from birth until discharge from the hospital, and every day during digestive episodes, that is to say during an interruption of enteral nutrition for more than 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| preterm neonates | Experimental | Preterm neonates (birth before 33 weeks of gestation) Receives: Other: Collection of stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal calprotectin level
Quantification of fecal calprotectin in stool samples collected every week and the first 3 days during an interruption over 48 hours of enteral feeding
Measured: From birth to hospital discharge (3 months maximum).
Secondary outcomes (1)
Evaluation of the performance of fecal calprotectin rapid assay.
The measurement results of fecal calprotectin obtained by the rapid quantitative immunochromatography method, will be compared with those obtained by conventional reference method (ELISA).
Measured: from birth to hospital discharge (3 months maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study start30 Sep 2013
- Primary completion22 Feb 2015
- Study completion22 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteropathy, Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Florence Campeotto, MD, PhD, Principal investigator, Necker Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010268
- Sponsor's protocol ID
- P111104
- Acronym
- CALPROPREMA
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2013
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Campeotto F, Elie C, Rousseau C, Giuseppi A, Hachem T, Gobalakichenane P, Le Touzey M, de Stefano M, Butel MJ, Kapel N. Faecal calprotectin and gut microbiota do not predict enteropathy in very preterm infants. Acta Paediatr. 2021 Jan;110(1):109-116. doi: 10.1111/apa.15354. Epub 2020 Sep 1.
PubMed 32418251
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.
- ClinicalTrials.gov ID
- NCT02010268
- Acronym / sponsor ID
- CALPROPREMA / P111104
- Conditions
- Enteropathy, Necrotizing Enterocolitis
- Keywords
- Faecal calprotectin, Feces, Preterm neonates, Enterocolitis, Enteropathy, Necrotizing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 22 Feb 2015 (actual)
- Study completion
- 22 Feb 2015 (actual)
- First posted
- 12 Dec 2013 (estimated)
- 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.
This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.
Detailed description
Enteropathy and necrotizing enterocolitis (NEC) are digestive emergencies in premature neonates which represent a major concern for the vital prognosis. It is therefore important to propose a tool for early diagnosis of these intestinal complications in order to avoid extended interruptions of enteral feeding at a period of life where growth (and digestive maturation) is in the foreground. Currently, the diagnosis of digestive impairment is based on classical clinical, biological (CRP, procalcitonin, fecal calprotectin, NFS) and radiological (abdomen without preparation) approaches, which induce on one hand a prolonged interruption of enteral feeding sometimes useless and even harmful for the intestinal maturation and, secondly, the establishment of a parenteral nutrition which is not risk-free. The study propose to dose the fecal calprotectin, a non-invasive marker of digestive inflammation, in order to validate the threshold decision proposed in a pilot study (350 µg/g of feces). Measurement of fecal calprotectin levels will be used as an integrated tool to build a powerful screening score combined to the usual parameters used in routine care for the diagnosis of and enteropathy and necrotizing enterocolitis (NEC) in premature neonates. A cohort of preterm infants born at a gestational age of 33 weeks or less will be included from birth. A stool sample will be collected from the diaper once a week, from birth until discharge from the hospital, and every day during gastrointestinal events (interruption of enteral feeding over 48 hours). The study will evaluate the performance of the rapid assay of fecal calprotectin by quantitative immunochromatography compared to the reference method by enzyme-linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preterm neonates | Experimental | Other: Collection of stool samplesPreterm neonates (birth before 33 weeks of gestation) |
Who may qualify
- Ages
- Up to 33 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants prematurely born at a gestational age of 33 weeks or less (or before the 7th month of pregnancy).
- Patient whose parents or holders of parental authority signed an informed consent.
Key exclusion criteria (2 listed)
- Patient with a malformation.
- Lack of signature of the consent by parents or holders of parental authority.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of stool samplesA stool sample will be collected once a week from birth until discharge from the hospital, and every day during digestive episodes, that is to say during an interruption of enteral nutrition for more than 48 hours. | Other | preterm neonates |
Primary outcome
fecal calprotectin level
Time frame: From birth to hospital discharge (3 months maximum).
Quantification of fecal calprotectin in stool samples collected every week and the first 3 days during an interruption over 48 hours of enteral feeding
1 secondary outcome
Evaluation of the performance of fecal calprotectin rapid assay.
Time frame: from birth to hospital discharge (3 months maximum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Results publication: PubMed 32418251Campeotto F, Elie C, Rousseau C, Giuseppi A, Hachem T, Gobalakichenane P, Le Touzey M, de Stefano M, Butel MJ, Kapel N. Faecal calprotectin and gut microbiota do not predict enteropathy in very preterm infants. Acta Paediatr. 2021 Jan;110(1):109-116. doi: 10.1111/apa.15354. Epub 2020 Sep 1.
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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. This study is not recruiting at the moment.
Florence Campeotto, MD, PhD principal investigator
Necker Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of stool samples in people with Enteropathy, Necrotizing Enterocolitis, run by Assistance Publique - Hôpitaux de Paris 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 2 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: finished, as of the sponsor's last update on 8 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal calprotectin level (time frame: From birth to hospital discharge (3 months maximum).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02010268, which also lists 1 linked publication.
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 8 Sep 2025.