Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515210
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Profiling of Anti-inflammatory Fibre Supplements in Patients with Ulcerative Colitis Towards Personalized Complementary Strategies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAIF-UC
Brief Summary:
The goal of this clinical trial is to determine the clinical effects of two different dietary fibre supplements acacia gum AG and microcrystalline cellulose MCC in patients with ulcerative colitis The main question it aims to answer is Can the fibre supplements reduce gut inflammation fecal calprotectin
Researchers will compare AG and MCC to a placebo a look-alike substance that contains no fibre to see if the fibre supplements improve inflammation in ulcerative colitis
Participants will add their assigned fibre supplement or placebo to their usual diet daily for 6 weeks They will visit the clinic at baseline week 3 and week 6 to provide samples stool blood and complete various questionnaires
Researchers will compare AG and MCC to a placebo a look-alike substance that contains no fibre to see if the fibre supplements improve inflammation in ulcerative colitis
Participants will add their assigned fibre supplement or placebo to their usual diet daily for 6 weeks They will visit the clinic at baseline week 3 and week 6 to provide samples stool blood and complete various questionnaires
Detailed Description:
Prevalence and incidence of inflammatory bowel diseases IBD including ulcerative colitis UC is rising rapidly in Canada and the rates are amongst the highest globally Crohns and Colitis Canada 2023 UC is a chronic disease characterized by colonic inflammation often inadequately managed in the long-term with immunosuppressive medications that can increase risk of infections and malignancies Kayal Shah 2019 Alternative complementary strategies are therefore necessary to improve patient outcomes
A potential target for such strategies may be the gut microbiome which can predict failure of standard therapy in pediatric UC Michail et al 2012 Putative pro-inflammatory microbes are enriched in patients with IBD compared to healthy controls and disease phenotypes can be transferred via microbiome transplantation into germ-free mice Nagao-Kitamoto et al 2016 Birtton et al 2019 suggesting a causal role of the gut microbiome in IBD Fibre-based treatments for UC have been proposed and tested for UC but results are mixed quite modest in many cases and many gaps remain in defining the most appropriate clinical approach Di Rosa et al 2022 Limketkai et al 2020
Dietary fibre has great potential as a safe complementary microbiome-targeted treatment strategy to reduce inflammation in UC Food supplementation with fermentable fibres alters microbiome composition So et al 2018 and increases microbial production of bioactive metabolites like short-chain fatty acids SCFAs that can attenuate inflammation Parada Venegas et al 2019 Levine et al 2018 Provision of growth substrates in the form of fibre also enhances gut barrier function by decreasing mucus degradation thus reducing bacterial encroachment and immune activation that may drive inflammation Desai et al 2016 Earle et al 2015 However specific fibre structures elicit distinct health effects due to differences in physicochemical properties Gill et al 2020 Therefore important open questions remain such as which fibres and physicochemical properties are most beneficial in the context of UC and are their effects microbiome-dependent
Hypothesis Acacia gum AG soluble and fermentable fibre and microcrystalline cellulose MCC insoluble and non-fermentable fibre will decrease gut inflammation in patients with UC but through different mechanisms given their differences in fermentability
The overall goal of this study is to determine the clinical effects of AG and MCC in patients with UC using normalization of FCP as the primary outcome
Voluntary trial extension Participants in whom the primary outcome has been achieved at week 6 will be invited to participate in an optional completely voluntary extension of the trial and continue their assigned treatment for an additional six weeks This will allow for exploratory assessment of longer-term efficacy of the fibres primary and secondary outcomes assessed again at week 12 Apart from the planned study if a clinical decision is made by the patient and physician to perform sigmoidoscopy or colonoscopy which is justified in many cases bio samples and data from these procedures will be collected if patients agree The procedure will not be a research procedure but the patients will be approached and consented for bio sample collection The optional extension will advantageously provide further biological insights into the effects of the fibres and can inform future intervention studies
A potential target for such strategies may be the gut microbiome which can predict failure of standard therapy in pediatric UC Michail et al 2012 Putative pro-inflammatory microbes are enriched in patients with IBD compared to healthy controls and disease phenotypes can be transferred via microbiome transplantation into germ-free mice Nagao-Kitamoto et al 2016 Birtton et al 2019 suggesting a causal role of the gut microbiome in IBD Fibre-based treatments for UC have been proposed and tested for UC but results are mixed quite modest in many cases and many gaps remain in defining the most appropriate clinical approach Di Rosa et al 2022 Limketkai et al 2020
Dietary fibre has great potential as a safe complementary microbiome-targeted treatment strategy to reduce inflammation in UC Food supplementation with fermentable fibres alters microbiome composition So et al 2018 and increases microbial production of bioactive metabolites like short-chain fatty acids SCFAs that can attenuate inflammation Parada Venegas et al 2019 Levine et al 2018 Provision of growth substrates in the form of fibre also enhances gut barrier function by decreasing mucus degradation thus reducing bacterial encroachment and immune activation that may drive inflammation Desai et al 2016 Earle et al 2015 However specific fibre structures elicit distinct health effects due to differences in physicochemical properties Gill et al 2020 Therefore important open questions remain such as which fibres and physicochemical properties are most beneficial in the context of UC and are their effects microbiome-dependent
Hypothesis Acacia gum AG soluble and fermentable fibre and microcrystalline cellulose MCC insoluble and non-fermentable fibre will decrease gut inflammation in patients with UC but through different mechanisms given their differences in fermentability
The overall goal of this study is to determine the clinical effects of AG and MCC in patients with UC using normalization of FCP as the primary outcome
Voluntary trial extension Participants in whom the primary outcome has been achieved at week 6 will be invited to participate in an optional completely voluntary extension of the trial and continue their assigned treatment for an additional six weeks This will allow for exploratory assessment of longer-term efficacy of the fibres primary and secondary outcomes assessed again at week 12 Apart from the planned study if a clinical decision is made by the patient and physician to perform sigmoidoscopy or colonoscopy which is justified in many cases bio samples and data from these procedures will be collected if patients agree The procedure will not be a research procedure but the patients will be approached and consented for bio sample collection The optional extension will advantageously provide further biological insights into the effects of the fibres and can inform future intervention studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None