Ulcerative Colitis Chronic Moderate Clinical Trial
Official title:
A Pilot Randomized, Double-blind, Placebo-controlled Trial to Investigate the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease
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 | Recruiting |
Enrollment | 100 |
Est. completion date | January 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - 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). Exclusion criteria: - Pregnancy, breastfeeding, allergy to seafood or marine products - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | Mediclinic City Hospital | Dubai | |
United Arab Emirates | Mediclinic Parkview Hospital | Dubai |
Lead Sponsor | Collaborator |
---|---|
Mohammed Bin Rashid University of Medicine and Health Sciences | Dubai Health Authority, Mediclinic Middle East, Rashid Hospital |
United Arab Emirates,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the change in plasma levels of cytokines between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | Cytokines will be measured in plasma samples. | Baseline and after 6 months | |
Primary | To assess the change in plasma levels of marker of inflammation between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | Marker of inflammation will be measured in plasma samples. | Baseline and after 6 months | |
Primary | To assess the change in biopsy mRNA levels between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | The mRNA levels of transcription factors involved in inflammation will be measured in tissue biopsy samples | Baseline and after 6 months | |
Primary | To assess the change in the biopsy mRNA levels between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | The mRNA levels of cytokines involved in inflammation will be measured in tissue biopsy samples | Baseline and after 6 months | |
Primary | To assess the change in the biopsy mRNA levels between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | The mRNA levels of markers involved in inflammation will be measured in tissue biopsy samples | Baseline and after 6 months | |
Primary | To assess the change in the proteins expression between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | The proteins expression of transcription factors involved in inflammation will be measured in tissue biopsy samples | Baseline and after 6 months | |
Primary | To assess the change in the proteins expression between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | The proteins expression cytokines involved in inflammation will be measured in tissue biopsy samples | Baseline and after 6 months | |
Primary | To assess the change in the proteins expression between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment | The proteins expression of markers involved in inflammation will be measured in tissue biopsy samples | Baseline and after 6 months | |
Secondary | To assess the change in routine clinical parameters between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment: | Mayo score, which are based on ratings of frequency and severity of clinical symptoms and endoscopic activity will be measured. | Baseline and after 2 months and after 4 months and after 6 months | |
Secondary | To assess the change in routine clinical parameters between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment: | Complete blood count will be measured | Baseline and after 2 months and after 4 months and after 6 months | |
Secondary | To assess the change in routine clinical parameters between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment: | Erythrocyte sedimentation rate will be measured | Baseline and after 2 months and after 4 months and after 6 months | |
Secondary | To assess the change in routine clinical parameters between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment: | Serum C-reactive protein will be measured | Baseline and after 2 months and after 4 months and after 6 months | |
Secondary | To assess the change in routine clinical parameters between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment: | Serum albumin will be measured | Baseline and after 2 months and after 4 months and after 6 months | |
Secondary | To assess the change in routine clinical parameters between IBD patients treated with Frondanol and those treated with placebo at baseline and after six months of treatment: | Fecal calprotectin will be measured | Baseline and after 2 months and after 4 months and after 6 months |
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