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
INTRODUCTION: Inflammatory bowel disease (IBD), consisting of Crohn's disease and ulcerative colitis, is a debilitating condition with a rising incidence globally over recent years. Frondanol, a widely available nutraceutical extract of the edible sea cucumber Cucumaria frondosa has been report...
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ftpubmed:oai:pubmedcentral.nih.gov:9760652 2023-05-15T15:59:39+02:00 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 Ghelani, Hardik Adrian, Thomas Edward Ho, Samuel B. Akhras, Jamil Azar, Aida J. Jan, Reem Kais 2022-12-01 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9760652/ http://www.ncbi.nlm.nih.gov/pubmed/36544548 https://doi.org/10.1016/j.conctc.2022.101046 en eng Elsevier http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9760652/ http://www.ncbi.nlm.nih.gov/pubmed/36544548 http://dx.doi.org/10.1016/j.conctc.2022.101046 © 2022 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). CC-BY-NC-ND Contemp Clin Trials Commun Article Text 2022 ftpubmed https://doi.org/10.1016/j.conctc.2022.101046 2022-12-25T01:44:12Z INTRODUCTION: Inflammatory bowel disease (IBD), consisting of Crohn's disease and ulcerative colitis, is a debilitating condition with a rising incidence globally over recent years. Frondanol, a widely available nutraceutical extract of the edible sea cucumber Cucumaria frondosa has been reported to possess potent anti-inflammatory effects, likely mediated by the inhibition of 5-lipoxygenase and 12-lipoxygenase pathways, 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. Here we describe the study protocol of a pilot randomized, double-blinded, placebo-controlled trial of Frondanol in patients with mild to moderate IBD who are on standard therapy. MATERIAL AND METHODS: 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 stool samples will be obtained during routine visits at baseline, and after three months and six months of treatment, and tissue samples from colon biopsies will be obtained during clinically indicated colonoscopies at baseline and after six months of treatment. The levels of inflammatory markers will be compared in serum and tissue samples between patients treated with Frondanol and those treated with placebo, and findings will be correlated with clinical and histological parameters. DISCUSSION: If proven beneficial, treatment with Frondanol may increase the likelihood of patients remaining in remission and potentially provide an effective, natural and safe addition/alternative for treatment-naive patients in the future. (Clinical trial registration number: NCT05194007). Text Cucumaria frondosa PubMed Central (PMC) Contemporary Clinical Trials Communications 31 101046 |
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Article Ghelani, Hardik Adrian, Thomas Edward Ho, Samuel B. Akhras, Jamil Azar, Aida J. Jan, Reem Kais 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 |
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Article |
description |
INTRODUCTION: Inflammatory bowel disease (IBD), consisting of Crohn's disease and ulcerative colitis, is a debilitating condition with a rising incidence globally over recent years. Frondanol, a widely available nutraceutical extract of the edible sea cucumber Cucumaria frondosa has been reported to possess potent anti-inflammatory effects, likely mediated by the inhibition of 5-lipoxygenase and 12-lipoxygenase pathways, 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. Here we describe the study protocol of a pilot randomized, double-blinded, placebo-controlled trial of Frondanol in patients with mild to moderate IBD who are on standard therapy. MATERIAL AND METHODS: 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 stool samples will be obtained during routine visits at baseline, and after three months and six months of treatment, and tissue samples from colon biopsies will be obtained during clinically indicated colonoscopies at baseline and after six months of treatment. The levels of inflammatory markers will be compared in serum and tissue samples between patients treated with Frondanol and those treated with placebo, and findings will be correlated with clinical and histological parameters. DISCUSSION: If proven beneficial, treatment with Frondanol may increase the likelihood of patients remaining in remission and potentially provide an effective, natural and safe addition/alternative for treatment-naive patients in the future. (Clinical trial registration number: NCT05194007). |
format |
Text |
author |
Ghelani, Hardik Adrian, Thomas Edward Ho, Samuel B. Akhras, Jamil Azar, Aida J. Jan, Reem Kais |
author_facet |
Ghelani, Hardik Adrian, Thomas Edward Ho, Samuel B. Akhras, Jamil Azar, Aida J. Jan, Reem Kais |
author_sort |
Ghelani, Hardik |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Elsevier |
publishDate |
2022 |
url |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9760652/ http://www.ncbi.nlm.nih.gov/pubmed/36544548 https://doi.org/10.1016/j.conctc.2022.101046 |
genre |
Cucumaria frondosa |
genre_facet |
Cucumaria frondosa |
op_source |
Contemp Clin Trials Commun |
op_relation |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9760652/ http://www.ncbi.nlm.nih.gov/pubmed/36544548 http://dx.doi.org/10.1016/j.conctc.2022.101046 |
op_rights |
© 2022 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
op_rightsnorm |
CC-BY-NC-ND |
op_doi |
https://doi.org/10.1016/j.conctc.2022.101046 |
container_title |
Contemporary Clinical Trials Communications |
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31 |
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101046 |
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1766395576135450624 |