Pragmatic randomised controlled study to assess the effectiveness of two patient management strategies in mild-to-moderate Ulcerative Colitis

Completed

• Conditions: irritatable bowel disease (IBD); proctocolitis; 10017969

• Registration Number: NL-OMON52790
• Lead Sponsor: Ferring

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1) Adult Patients ( >= 18 years old at Baseline)
2) Active Mild-to-moderate Ulcerative Colitis patients defined with:
a. Rectal bleeding (RB) subscore >= 1 at Baseline, and
b. Mayo endoscopic subscore >= 1, and
c. Total of [RB + SF + Mayo endoscopic subscore] between 2 and 6.
3) Patients who were on 5-ASA <= 2.4 g/day, or no Treatment regimen at Baseline
(prior
escalating the therapy)
4) Patients who are willing to use Faecal Calprotectin Home Test
5) Patients with internet access and smartphone with camera
6) Patients who have received adequate information regarding the study, and are
able to
understand and voluntarily sign the Informed Consent Form before any
study-related
procedures.

Exclusion Criteria

1) Patients with contra-indications to 5-ASA and/or 2nd generation
corticosteroids as per
SmPC
2) Patients currently on Nonsteroidal anti-inflammatory drug (NSAID) and
Proton-pump
inhibitor (PPI) treatment as they affect FC levels
3) Patients exposed to immunosuppressants and/or biologics within 6 months
prior to
Baseline
4) Patients with positive stool culture up to 2-weeks prior Baseline (bacterial
pathogens -
SSYC, Clostridium Difficile, toxinC, ova and parasites) having received no
specific
treatment to treat infection
5) Patients not willing to perform FC self-monitoring at home
6) Patients not willing to undergo a flexible sigmoidoscopy/colonoscopy at the
end of study
7) Patients currently enrolled in another interventional study
8) Pregnant/breastfeeding woman
9) Known mental incapacity or language barriers precluding adequate
understanding of the
Informed Consent information and the study activities
10) Inability by the judgement of the investigator to participate in the study
for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified