Fecal Microbiota Alterations in Steroid Refractory Active Colitis Ulcerosa

NCT03460847 | Completed

• 1 other identifier: 29-316 ex 16/17
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Alterations in the intestinal microbiota have been associated to disease pathogenesis in ulcerative colitis. Refractory disease to standard medical therapy as corticosteroids often leads to an unfavourable course in patients suffering from this disorder. This study proposal aims at investigating changes in the intestinal microbiota that can predict a therapy refractory course of ulcerative colitis (UC) and may be used to identify high risk patients in an early phase of their disease.

Conditions

Colitis, Ulcerative

Outcome Measures

Primary Outcomes (1)

• Microbiota alterations

  To assess if alterations of the fecal microbiota are associated with a failure to respond to steroid therapy within 28 days in patients with ulcerative colitis. The microbiota will be assessed by 16s RNA analysis.

  28 days

Interventions

Steroids DRUG

Patients with active colitis ulcerosa who need steroids because of their disease course. 1mg/kg bodyweight for one week, followed by a tapping periode.

Also known as: Aprednisolon, Prednisolut

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from an active colitis ulcerosa and requiring steroids as therapy.

You may qualify if:

• Active ulcerative colitis with a Lichtiger score ≥4
• Written informed consent
• Established or suspected diagnosis of ulcerative colitis or indeterminate colitis

You may not qualify if:

• No follow up possible
• Bacterial intestinal infections (C. difficile, Salmonella, EHEC, Campylobacter, Shigella, Yersinia), parasitic or viral infection causing acute infectious diarrhea at baseline.
• Diagnosis of Crohn´s disease
• Planned initiation or discontinuation of probiotic therapy between baseline and follow up visit

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

LKH Graz

Graz, Styria, 8036, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Steroids

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Christoph Hoegenauer, Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 9, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Locations

AU (1)