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

NCT06228352 | Not Yet Recruiting

• 2 other identifiers: APHP2211792022-A01579-34
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Clostridioides difficile infection; Intestinal dysbiosis; Bile acid profiles

Outcome Measures

Primary Outcomes (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.

  Day 0

Secondary Outcomes (4)

• Faecal microbiota

  Day 0

• Short-chain fatty acids

  Day 0

• Metabolic pathway of tryptophan

  Day 0

• Fecal calprotectin

  Day 0

Study Arms (3)

Ulcerative colitis flare-up

Patient 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.

Other: Feces collection

Ulcerative colitis remission

Patient 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.

Other: Feces collection

Controls

Paediatric 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.

Other: Feces collection

Interventions

Feces collection OTHER

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.

Controls; Ulcerative colitis flare-up; Ulcerative colitis remission

Eligibility Criteria

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

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.

You may qualify if:

• Pediatric patients (\<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.
• Information and consent of parents and the patient

You may not qualify if:

• 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
• 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.
• 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 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.
• Patient with IBD unclassified or Crohn's disease.
• Patient with isolated proctitis (\<5 cm).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces

MeSH Terms

Conditions

Colitis, Ulcerative; Clostridium Infections

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bénédicte Pigneur, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Frédéric Barbut, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Central Study Contacts

Bénédicte Pigneur, MD

CONTACT

1 44 49 25 16; benedicte.pigneur@aphp.fr

Hélène Morel

CONTACT

1 71 19 63 46; helene.morel@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)