Ulcerative Colitis Chronic MildPhase 2/3NCT05194007
Investigating the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease
A Phase 2/3 study testing Frondanol in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 2 sites in United Arab Emirates.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate, Crohn Colitis
- What is being tested?
- Frondanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 19 Feb 2022to 19 Nov 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
Mediclinic City Hospital
Dubai
Mediclinic Parkview Hospital
Dubai
About this study
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.
Read the detailed description
Inflammatory bowel disease (IBD), consisting of Crohn's disease and ulcerative colitis, is a debilitating condition, particularly during active periods (flares) of the disease and can sometimes lead to life-threatening complications. IBD is characterized by chronic gut inflammation resulting in symptoms such as severe diarrhea, abdominal pain, blood in stool, fatigue and unintended weight loss, which significantly affect the quality of life of patients. Although the exact mechanism underlying the chronic gut inflammation is not fully understood, several cytokine networks are thought to be involved. Currently, treatment of IBD relies on minimizing symptoms and improving quality of life through the control of disease progression and complications; however, these drugs have significant systemic side effects that reduce their tolerability. Moreover, up to 40% of patients still exhibit non-response to therapy, and these treatment-refractory patients would require alternative therapeutic approaches. Frondanol, a widely available nutraceutical extract of the edible sea cucumber, Cucumaria frondosa, has been reported to possess potent anti-inflammatory effects in both animals and humans, whilst showing no signs of toxicity. The potent anti-inflammatory effects of Frondanol in a mouse model of IBD provide encouragement for investigating its effects in human IBD patients. The proposed study is a pilot, double-blinded, placebo-controlled trial of Frondanol in patients with IBD (Crohn's disease or ulcerative colitis) who are currently in remission and are on standard therapy. One hundred patients will be randomized (1:1) to receive Frondanol or placebo as an adjunct to their standard therapy for the period of six months. Blood and tissue samples from colon biopsies obtained during routine visits and endoscopies at baseline and six months later will be collected. The levels of inflammatory markers such as myeloperoxidase, tumor necrosis factor (TNF)-α, interleukin (IL)1β, IL6, IL17A, IL22, interferon gamma (IFN-γ) and several other inflammatory markers will be compared between patients treated with Frondanol and those treated with placebo, and the findings will be correlated with clinical and histological parameters. Over the past 25 years, it is estimated that more than 3 million Frondanol capsules have been consumed on the human market with no reported side effects. An even larger amount has been consumed on the veterinary market without a single reported incident. If proven beneficial, Frondanol, will be a useful supplement in treating the underlying chronic gut inflammation in IBD patients, increasing the likelihood of patients remaining in remission and potentially providing an effective, natural and safe treatment for treatment naive patients in the future.
- Being tested
- Frondanol, Placebo
- Keywords
- inflammatory bowel disease, Crohn disease, ulcerative colitis, frondanol, randomized controlled trial, placebo-controlled, chronic bowel inflammation
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FrondanolDrug
Frondanol capsule (1000 mg) will be administered orally (Twice daily) in the double blind settings
PlaceboDrug
Placebo (corn starch) capsule will be administered orally (Twice daily) in the double blind settings
| Study group | Role | What they receive |
|---|---|---|
| Experimental -Frondanol | Experimental | Eligible participants will receive Frondanol capsule orally (1000 mg capsule twice daily) for 6 months Receives: Drug: Frondanol |
| Placebo | Placebo comparator | Eligible participants will receive placebo capsule (twice daily) for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 6 months
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.
Measured: Baseline and after 6 months
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
Measured: Baseline and after 6 months
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
Measured: Baseline and after 6 months
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
Measured: Baseline and after 6 months
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
Measured: Baseline and after 6 months
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
Measured: Baseline and after 6 months
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
Measured: Baseline and after 6 months
Secondary outcomes (6)
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.
Measured: Baseline and after 2 months and after 4 months and after 6 months
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
Measured: Baseline and after 2 months and after 4 months and after 6 months
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
Measured: Baseline and after 2 months and after 4 months and after 6 months
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
Measured: Baseline and after 2 months and after 4 months and after 6 months
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
Measured: Baseline and after 2 months and after 4 months and after 6 months
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
Measured: Baseline and after 2 months and after 4 months and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start19 Feb 2022
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis Chronic MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel group, randomized, double-blind, placebo-controlled pilot trial where participants will be randomized to receive either Frondanol 1000mg twice daily or placebo twice daily for 6 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mediclinic Middle East, Rashid Hospital, Dubai Health Authority
- Responsible party
- Principal investigator, Reem Jan, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194007
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaser A, Zeissig S, Blumberg RS. Inflammatory bowel disease. Annu Rev Immunol. 2010;28:573-621. doi: 10.1146/annurev-immunol-030409-101225.
PubMed 20192811Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
PubMed 22001864Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
PubMed 29050646Friedrich M, Pohin M, Powrie F. Cytokine Networks in the Pathophysiology of Inflammatory Bowel Disease. Immunity. 2019 Apr 16;50(4):992-1006. doi: 10.1016/j.immuni.2019.03.017.
PubMed 30995511Kuhn KA, Schulz HM, Regner EH, Severs EL, Hendrickson JD, Mehta G, Whitney AK, Ir D, Ohri N, Robertson CE, Frank DN, Campbell EL, Colgan SP. Bacteroidales recruit IL-6-producing intraepithelial lymphocytes in the colon to promote barrier integrity. Mucosal Immunol. 2018 Mar;11(2):357-368. doi: 10.1038/mi.2017.55. Epub 2017 Aug 16.
PubMed 28812548Lee JS, Tato CM, Joyce-Shaikh B, Gulen MF, Cayatte C, Chen Y, Blumenschein WM, Judo M, Ayanoglu G, McClanahan TK, Li X, Cua DJ. Interleukin-23-Independent IL-17 Production Regulates Intestinal Epithelial Permeability. Immunity. 2015 Oct 20;43(4):727-38. doi: 10.1016/j.immuni.2015.09.003. Epub 2015 Sep 29.
PubMed 26431948Sairenji T, Collins KL, Evans DV. An Update on Inflammatory Bowel Disease. Prim Care. 2017 Dec;44(4):673-692. doi: 10.1016/j.pop.2017.07.010. Epub 2017 Oct 5.
PubMed 29132528Ben-Horin S, Chowers Y. Tailoring anti-TNF therapy in IBD: drug levels and disease activity. Nat Rev Gastroenterol Hepatol. 2014 Apr;11(4):243-55. doi: 10.1038/nrgastro.2013.253. Epub 2014 Jan 7.
PubMed 24393836Guerra I, Bermejo F. Management of inflammatory bowel disease in poor responders to infliximab. Clin Exp Gastroenterol. 2014 Sep 18;7:359-67. doi: 10.2147/CEG.S45297. eCollection 2014.
PubMed 25258548Kelly MS. Echinoderms: their culture and bioactive compounds. Prog Mol Subcell Biol. 2005;39:139-65.
PubMed 17152697Janakiram NB, Mohammed A, Bryant T, Lightfoot S, Collin PD, Steele VE, Rao CV. Improved innate immune responses by Frondanol A5, a sea cucumber extract, prevent intestinal tumorigenesis. Cancer Prev Res (Phila). 2015 Apr;8(4):327-37. doi: 10.1158/1940-6207.CAPR-14-0380. Epub 2015 Feb 5.
PubMed 25657017Janakiram NB, Mohammed A, Zhang Y, Choi CI, Woodward C, Collin P, Steele VE, Rao CV. Chemopreventive effects of Frondanol A5, a Cucumaria frondosa extract, against rat colon carcinogenesis and inhibition of human colon cancer cell growth. Cancer Prev Res (Phila). 2010 Jan;3(1):82-91. doi: 10.1158/1940-6207.CAPR-09-0112.
PubMed 20051375Subramanya SB, Chandran S, Almarzooqi S, Raj V, Al Zahmi AS, Al Katheeri RA, Al Zadjali SA, Collin PD, Adrian TE. Frondanol, a Nutraceutical Extract from Cucumaria frondosa, Attenuates Colonic Inflammation in a DSS-Induced Colitis Model in Mice. Mar Drugs. 2018 Apr 30;16(5):148. doi: 10.3390/md16050148.
PubMed 29710854Ghelani H, Adrian TE, Ho SB, Akhras J, Azar AJ, Jan RK. Study protocol for a pilot randomized, double-blind, placebo-controlled trial to investigate the anti-inflammatory effects of Frondanol in adults with inflammatory bowel disease. Contemp Clin Trials Commun. 2022 Dec 1;31:101046. doi: 10.1016/j.conctc.2022.101046. eCollection 2023 Feb.
PubMed 36544548
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Double-blind, Placebo-controlled Trial to Investigate the Anti-inflammatory Effects of Frondanol in Adults With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05194007
- Acronym / sponsor ID
- 1
- Keywords
- inflammatory bowel disease, Crohn disease, ulcerative colitis, frondanol, randomized controlled trial, placebo-controlled, chronic bowel inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Collaborators
- Mediclinic Middle East, Rashid Hospital, Dubai Health Authority
- Study start
- 19 Feb 2022 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inflammatory bowel disease (IBD), consisting of Crohn's disease and ulcerative colitis, is a debilitating condition, particularly during active periods (flares) of the disease and can sometimes lead to life-threatening complications. IBD is characterized by chronic gut inflammation resulting in symptoms such as severe diarrhea, abdominal pain, blood in stool, fatigue and unintended weight loss, which significantly affect the quality of life of patients. Although the exact mechanism underlying the chronic gut inflammation is not fully understood, several cytokine networks are thought to be involved. Currently, treatment of IBD relies on minimizing symptoms and improving quality of life through the control of disease progression and complications; however, these drugs have significant systemic side effects that reduce their tolerability. Moreover, up to 40% of patients still exhibit non-response to therapy, and these treatment-refractory patients would require alternative therapeutic approaches. Frondanol, a widely available nutraceutical extract of the edible sea cucumber, Cucumaria frondosa, has been reported to possess potent anti-inflammatory effects in both animals and humans, whilst showing no signs of toxicity. The potent anti-inflammatory effects of Frondanol in a mouse model of IBD provide encouragement for investigating its effects in human IBD patients. The proposed study is a pilot, double-blinded, placebo-controlled trial of Frondanol in patients with IBD (Crohn's disease or ulcerative colitis) who are currently in remission and are on standard therapy. One hundred patients will be randomized (1:1) to receive Frondanol or placebo as an adjunct to their standard therapy for the period of six months. Blood and tissue samples from colon biopsies obtained during routine visits and endoscopies at baseline and six months later will be collected. The levels of inflammatory markers such as myeloperoxidase, tumor necrosis factor (TNF)-α, interleukin (IL)1β, IL6, IL17A, IL22, interferon gamma (IFN-γ) and several other inflammatory markers will be compared between patients treated with Frondanol and those treated with placebo, and the findings will be correlated with clinical and histological parameters. Over the past 25 years, it is estimated that more than 3 million Frondanol capsules have been consumed on the human market with no reported side effects. An even larger amount has been consumed on the veterinary market without a single reported incident. If proven beneficial, Frondanol, will be a useful supplement in treating the underlying chronic gut inflammation in IBD patients, increasing the likelihood of patients remaining in remission and potentially providing an effective, natural and safe treatment for treatment naive patients in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel group, randomized, double-blind, placebo-controlled pilot trial where participants will be randomized to receive either Frondanol 1000mg twice daily or placebo twice daily for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Experimental -Frondanol | Experimental | Drug: FrondanolEligible participants will receive Frondanol capsule orally (1000 mg capsule twice daily) for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboEligible participants will receive placebo capsule (twice daily) for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FrondanolFrondanol capsule (1000 mg) will be administered orally (Twice daily) in the double blind settings | Drug | Experimental -Frondanol |
| PlaceboPlacebo (corn starch) capsule will be administered orally (Twice daily) in the double blind settings | Drug | Placebo |
Primary outcome
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
Time frame: Baseline and after 6 months
Cytokines will be measured in plasma samples.
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
Time frame: Baseline and after 6 months
Marker of inflammation will be measured in plasma samples.
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
Time frame: Baseline and after 6 months
The mRNA levels of transcription factors involved in inflammation will be measured in tissue biopsy samples
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
Time frame: Baseline and after 6 months
The mRNA levels of cytokines involved in inflammation will be measured in tissue biopsy samples
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
Time frame: Baseline and after 6 months
The mRNA levels of markers involved in inflammation will be measured in tissue biopsy samples
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
Time frame: Baseline and after 6 months
The proteins expression of transcription factors involved in inflammation will be measured in tissue biopsy samples
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
Time frame: Baseline and after 6 months
The proteins expression cytokines involved in inflammation will be measured in tissue biopsy samples
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
Time frame: Baseline and after 6 months
The proteins expression of markers involved in inflammation will be measured in tissue biopsy samples
6 secondary outcomes
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:
Time frame: Baseline and after 2 months and after 4 months and after 6 months
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:
Time frame: Baseline and after 2 months and after 4 months and after 6 months
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:
Time frame: Baseline and after 2 months and after 4 months and after 6 months
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:
Time frame: Baseline and after 2 months and after 4 months and after 6 months
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:
Time frame: Baseline and after 2 months and after 4 months and after 6 months
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:
Time frame: Baseline and after 2 months and after 4 months and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 20192811Kaser A, Zeissig S, Blumberg RS. Inflammatory bowel disease. Annu Rev Immunol. 2010;28:573-621. doi: 10.1146/annurev-immunol-030409-101225.
- Background: PubMed 22001864Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
- Background: PubMed 29050646Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
- Background: PubMed 30995511Friedrich M, Pohin M, Powrie F. Cytokine Networks in the Pathophysiology of Inflammatory Bowel Disease. Immunity. 2019 Apr 16;50(4):992-1006. doi: 10.1016/j.immuni.2019.03.017.
- Background: PubMed 28812548Kuhn KA, Schulz HM, Regner EH, Severs EL, Hendrickson JD, Mehta G, Whitney AK, Ir D, Ohri N, Robertson CE, Frank DN, Campbell EL, Colgan SP. Bacteroidales recruit IL-6-producing intraepithelial lymphocytes in the colon to promote barrier integrity. Mucosal Immunol. 2018 Mar;11(2):357-368. doi: 10.1038/mi.2017.55. Epub 2017 Aug 16.
- Background: PubMed 26431948Lee JS, Tato CM, Joyce-Shaikh B, Gulen MF, Cayatte C, Chen Y, Blumenschein WM, Judo M, Ayanoglu G, McClanahan TK, Li X, Cua DJ. Interleukin-23-Independent IL-17 Production Regulates Intestinal Epithelial Permeability. Immunity. 2015 Oct 20;43(4):727-38. doi: 10.1016/j.immuni.2015.09.003. Epub 2015 Sep 29.
- Background: PubMed 29132528Sairenji T, Collins KL, Evans DV. An Update on Inflammatory Bowel Disease. Prim Care. 2017 Dec;44(4):673-692. doi: 10.1016/j.pop.2017.07.010. Epub 2017 Oct 5.
- Background: PubMed 24393836Ben-Horin S, Chowers Y. Tailoring anti-TNF therapy in IBD: drug levels and disease activity. Nat Rev Gastroenterol Hepatol. 2014 Apr;11(4):243-55. doi: 10.1038/nrgastro.2013.253. Epub 2014 Jan 7.
- Background: PubMed 25258548Guerra I, Bermejo F. Management of inflammatory bowel disease in poor responders to infliximab. Clin Exp Gastroenterol. 2014 Sep 18;7:359-67. doi: 10.2147/CEG.S45297. eCollection 2014.
- Background: PubMed 17152697Kelly MS. Echinoderms: their culture and bioactive compounds. Prog Mol Subcell Biol. 2005;39:139-65.
- Background: PubMed 25657017Janakiram NB, Mohammed A, Bryant T, Lightfoot S, Collin PD, Steele VE, Rao CV. Improved innate immune responses by Frondanol A5, a sea cucumber extract, prevent intestinal tumorigenesis. Cancer Prev Res (Phila). 2015 Apr;8(4):327-37. doi: 10.1158/1940-6207.CAPR-14-0380. Epub 2015 Feb 5.
- Background: PubMed 20051375Janakiram NB, Mohammed A, Zhang Y, Choi CI, Woodward C, Collin P, Steele VE, Rao CV. Chemopreventive effects of Frondanol A5, a Cucumaria frondosa extract, against rat colon carcinogenesis and inhibition of human colon cancer cell growth. Cancer Prev Res (Phila). 2010 Jan;3(1):82-91. doi: 10.1158/1940-6207.CAPR-09-0112.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Frondanol in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 2 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline and after 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194007, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.