NCT05194007CompletedPhase 2/3
Investigating the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease
A Pilot Randomized, Double-blind, Placebo-controlled Trial to Investigate the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
This is a pilot, prospective, double-blinded, two-arm, randomized controlled trial of the efficacy of Frondanol in comparison to placebo in decreasing bowel inflammation in patients with a clinical diagnosis of inflammatory bowel disease who are in remission and on standard of care treatment.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 18 Nov 2021
- Start date
- 19 Feb 2022
- Primary completion date
- 19 Nov 2024
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05194007
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 13
- From 19 Feb 2022 to the primary completion date, 19 Nov 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Pregnancy, breastfeeding, allergy to seafood or marine products
Lab values
- Severe medical illness such as uncontrolled diabetes (HbA1C\>10), significant or unstable cardiovascular or pulmonary disease, impaired renal function (Cr\>2.0mg/dL), current or recent (\<1 year) malignancy, or other significant medical illness that in the view of the investigators may impair participation in the study.
Other
- Patients with severe IBD (defined by a Partial Mayo score of 7-9 and a total Mayo score of 11-12, with active symptoms) will not be eligible to participate in the study.
Who the study is looking for
- A confirmed clinical diagnosis of IBD of any duration, age 18 years or older, with mild to moderate disease and on standard therapy.
- The diagnostic criteria for IBD include the presence of chronic diarrhea for more than four weeks, and evidence of active inflammation on endoscopy and chronic changes on biopsy.
- Patients with stable mild to moderate IBD will be eligible for the study.
- Stable IBD is defined as having stable symptoms over a period of several weeks, diagnostic evaluation has been completed and the patient has been on consistent medication.
- Mild to moderate IBD is indicated by a Partial Mayo score (Mayo Clinic Score/Disease Activity Index for Colitis) of between 1-6, and a total of Mayo score of 1-10.
- For patients with Crohn's disease, only those with Crohn's colitis will be included (patients with small bowel disease are eligible to enter the trial as long as they also have large bowel inflammation).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mediclinic City Hospital Coordinator of this site? Confirm its status | Dubai | United Arab Emirates | Unknown status |
| Mediclinic Parkview Hospital Coordinator of this site? Confirm its status | Dubai | United Arab Emirates | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.