AzTrials
AzTrials

Ulcerative ColitisABRICONCT06228352

Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis

An observational study of Ulcerative Colitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis). Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Feces collection
How many people
80 participants
Where
1 siteFrance
Study dates
9 Jun 2026to Jun 2029
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 Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric patients consulting or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital, with ulcerative colitis (UC) in flare-up with and without Clostridioides difficile infection (CDI), patients UC in remission and healthy controls.

Who may be able to join

  • Pediatric patients (<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.
  • Information and consent of parents and the patient
  • Patient with UC, whatever the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.
  • UC in flare defined by a PUCAI score of between 35 and 65.
  • Non-inclusion criteria:
  • Patient with IBD unclassified or Crohn's disease.
Show all 22Show fewer
  • Patient with isolated proctitis (<5 cm).
  • Colectomized patients.
  • Patients with sclerosing cholangitis associated with their UC or liver disease.
  • Group 2: Patients in UC remission
  • Patient with UC, whatever the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.
  • UC in remission defined by a PUCAI score <10.
  • Non-inclusion criteria:
  • Patient with IBD unclassified or Crohn's disease.
  • Patient with isolated proctitis (<5 cm).
  • Colectomized patients.
  • Patients with sclerosing cholangitis associated with their UC or liver disease.
  • Group 3: Healthy control subjects
  • Patients hospitalized for an endoscopic assessment to control for abdominal pain, gastroesophageal reflux or polyposis.
  • Non-inclusion criteria:
  • Patient with chronic liver disease.
  • Patient with chronic digestive disease (celiac disease, IBD, chronic chronic).

Who cannot join

  • Patient who received antibiotic or antifungal treatment in the 4 weeks prior to inclusion.
  • Patients colonized by C. difficile.
  • Pregnant or breastfeeding young girl.
  • Refusal of the protocol by parents or patient.
  • For group 1: Patients with active UC

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Hôpital Necker-Enfants Malades

    Paris, 75015

    Bénédicte Pigneur, MD, 1 44 49 25 60 ext. +33, benedicte.pigneur@aphp.fr

    Antonin Lamazière

    Recruiting

Other trials in France

About this study

Official title: Is Clostridioides Difficile Infection Associated With Changes in Bile Acid Profiles in Children With Ulcerative Colitis

Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis).

Ulcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection.

The main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.

Read the detailed description

Ulcerative Colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by chronic inflammation of the colon. Clinical symptoms include bloody diarrhea associated with abdominal pain, fecal incontinence, urgency, and tenesmus. Approximately 15-20% of patients develop UC during childhood or adolescence, with a sustained worldwide rise of the incidence of IBD, particularly pediatric forms. While there are many similarities between adult- and childhood-onset UC, pediatric-onset UC appears to be more severe and extensive with more rapid spread of the disease leading to high morbidity, more severe acute flares and more frequent use of intravenous corticosteroids. To date, there is no medical treatment that can cure the disease but only treatments that shorten the duration of relapses or prevent them.

An imbalance in the composition of the intestinal microbiota named "dysbiosis" has been demonstrated in IBD. This dysbiosis is characterized by a strong instability of the microbiota over time, and a reduction of diversity and particularly a reduction in bacteria belonging to the Firmicutes and Bacteroidetes phyla with an increase in Proteobacteria and Actinobacteria. More recently, a UC-specific dysbiosis has been described including a decrease in butyrate-producing bacteria, in particular Faecalibacterium prausnitzii, and Roseburia hominis.

It has also been shown that if adult patients with UC in flare-up and remission have similar total fecal bile acids, they have a lower proportion of fecal secondary acids compared to healthy control subjects.

Patients with UC have an increased risk of Clostridioides difficile infection (CDI) and complications from the CDI (coletomy, deaths) as well as a higher risk of CDI recurrences. Clostridioides difficile is a strict anaerobic bacteria, which represents the main cause of post-antibiotic diarrhea.

The hypothesis of the project is that gut microbiota dysbiosis in patients with UC alters the bile acid profile and metabolite profile and could promote C difficile infection in these patients without any other risk factors such as antibiotics. To confirm this hypothesis, the investigating team proposes to study the microbiota, bile acid profiles and microbial metabolites in the stools of 40 pediatric-onset UC patients with a flare-up of their disease with (n=20) or without (n=20) a concomitant CDI and to compare them to healthy children (n=20) and UC children with clinical remission (n=20). Bile acids will be determined by high performance liquid chromatography coupled with tandem mass spectrometry detection, the short chain fatty acids and tryptophan derivatives derived from TRP and AGCC will be determined by GC-MS or LC-MS and the microbiota by the MiSeq technique.

The investigating team hopes to identify bile acid profiles predisposing for CDI and to correlate them with microbiota abnormalities. This will allow to better understand the factors associated with CDI but also to identify biomarkers of infection and maybe protective bacterial strains. In the long term, the investigating team hopes to find new therapeutic perspectives by providing bacteria of interest to transform bile acids and to protect against Clostridioides difficile.

Being tested
Feces collection
Keywords
Ulcerative colitis, Clostridioides difficile infection, Intestinal dysbiosis, Bile acid profiles
Medical subject headings
Colitis, Ulcerative, Clostridium Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feces collectionOther

    A single stool sample will be taken (a specific kit will be given to the patient for this) during a consultation for follow-up or hospitalization.

    Stool samples will be used to study the composition of the intestinal microbiota and to measure faecal biomarkers.

Study groups in NCT06228352
Study groupRoleWhat they receive
Ulcerative colitis flare-upPatient with ulcerative colitis, whatever the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months, presenting with a flare of UC defined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score between 35 and 65.
Receives: Other: Feces collection
Ulcerative colitis remissionPatient with ulcerative colitis, whatever the extent, except isolated proctitis (<5 cm), diagnosed for more than 3 months and in clinical remission defined by a Pediatric Ulcerative Colitis Activity Index (PUCAI) score under 10.
Receives: Other: Feces collection
ControlsPaediatric patients (<18 years) without chronic liver disease or chronic digestive disease (celiac disease, inflammatory bowel disease, chronic diarrhea) and hospitalized for an endoscopic examination to investigate abdominal pain, gastroesophageal reflux or polyposis.
Receives: Other: Feces collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composition of bile acids

    Description of the composition of primary and secondary bile acids. Fecal bile acids will be assayed by high performance liquid chromatography coupled with detection by tandem mass spectrometry and the quantification of each bile acid will be expressed as a percentage of total bile acids.

    The bile acid profile of the patients will be compared between the 3 groups: patients followed for ulcerative colitis (UC) in flare with or without a concomitant C difficile infection, patients with UC in clinical remission and healthy subjects without UC.

    Measured: Day 0

Secondary outcomes (4)
  1. Faecal microbiota

    The composition of the patients' faecal microbiota will be measured by targeted metagenomics (high-throughput sequencing of DNA coding for 16S RNA targeting the V3-V4 region). The analysis of the diversity of the microbiota will be carried out by calculating the Shannon index. This index will be compared between the groups with and without CDI.

    Measured: Day 0

  2. Short-chain fatty acids

    Analysis of fecal biomarkers. Short-chain fatty acids (SCFAs; acetate, propionate, butyrate and branched short-chain fatty acids) and metabolites of the tryptophan pathway will be determined by gas or liquid chromatography methods, coupled with mass spectrometric detection. The results will be compared between the 3 groups.

    Measured: Day 0

  3. Metabolic pathway of tryptophan

    Analysis of fecal biomarkers. Metabolites of tryptophan pathway will be determined by gas or liquid chromatography methods, coupled with mass spectrometric detection The results will be compared between the 3 groups.

    Measured: Day 0

  4. Fecal calprotectin

    Analysis of fecal biomarkers. Fecal calprotectin assay will be done by chemiluminescence assay. The results will be compared between the 3 groups.

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start9 Jun 2026
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228352
Sponsor's protocol ID
APHP221179
Other IDs
2022-A01579-34
Acronym
ABRICO
Status last verified
Jun 2026
First submitted
18 Jan 2024
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, 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 22 inclusion and 5 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 24 Jun 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 Bénédicte Pigneur, MD (1 44 49 25 16 ext. +33, benedicte.pigneur@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composition of bile acids (time frame: Day 0). 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 24 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in