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Compositional changes in gut microbiota following induction therapy in patients with active ulcerative colitis

Compositional changes in gut microbiota following induction therapy in patients with active ulcerative colitis - Changes in gut microbiota following induction therapy in active UC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45052
Enrollment
16
Registered
2014-04-02
Start date
2014-08-22
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis and inflammatory bowel disease

Interventions

None listed

Sponsors

Maag-darm-leverziekten
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age 18 - 60 years established diagnosis of ulcerative colitis (confirmed by clinical, endoscopic and histological features) moderate or severe disease activity (defined as a Mayo score >6 for patients with UC) indication for endoscopy (according to the Dutch CBO guidelines for diagnosis and treatment of IBD in adults) indication for induction therapy with oral prednisone (according to the Dutch CBO guidelines for diagnosis and treatment of IBD in adults) disease activity confirmed by endoscopy with at least ulcerative lesions present at baseline (ileo)colonoscopy signed informed consent

Exclusion criteria

Exclusion criteria: Concomitant gastrointestinal disorder Previous surgery for IBD Severe disease possibly requiring surgical treatment Isolated proctitis Systemic antibiotic, antiviral, or antifungal treatment during the last 2 months before participation Use of probiotics during the last 3 weeks before participation Use of antidiarrheal medications during the last week before participation Parenteral nutrition, vegetarianism, veganism, use of dietary supplements Alcohol misuse in the last year before participation (more than 3-4 units or 2-3 units per day for men and women respectively) Drug misuse in the last year before participation Pregnancy/lactation Obesity (defined as a body mass index > 30 kg/m2) Medical treatment for diabetes mellitus Serious comorbidities (precluding participation in the study in the opinion of the treating physician) Use of rectal or systemic steroid therapy, biological agents or methotrexate during the last 2 months before participation

Design outcomes

Primary

MeasureTime frame
Microbial composition of both FAM and MAM using a phylogenetic microarray (Human Intestinal Tract (HIT) Chip) and next generation sequencing.

Secondary

MeasureTime frame
Clinical disease activity indices Biochemical parameters (faecal calprotectin level, C-reactive protein level, full blood count, albumin level)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)