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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients (<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.

Information and consent of parents and the patient

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Feces collection

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Ulcerative colitis flare-up1 intervention
Group B: Ulcerative colitis remission1 intervention
Group C: Controls1 intervention

Trial outcomes

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.

Time frame
Day 0

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator