Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603519
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Impact of Dietary Intervention on Inflammation and Microbiome Composition Post-Colonoscopy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determining the Impact of Dietary Intervention on Inflammation and Microbiome Composition in Patients with Recurrent Polyps Post-Colonoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This study aims to investigate the impact of various healthy diets specifically a modified plant-based Mediterranean diet on the gut microbiome and overall well-being post-colonoscopy The investigators hypothesize that certain diets can positively influence gut bacteria reducing inflammation and enhancing metabolic signals
To explore this they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms Additionally they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome immune function and overall metabolism
To explore this they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms Additionally they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome immune function and overall metabolism
Detailed Description:
An altered intestinal gut microbiota ie dysbiosis has been associated with the development of intestinal diseases including inflammatory bowel disease colorectal cancer CRC and metabolic diseases such as obesity type 2 diabetes mellitus T2DM and cardiovascular disease Metagenomic analyses have revealed microbial biomarkers and ecological signatures in the fecal microbiome of CRC patients correlating with chronic inflammation and gut dysbiosis These factors have demonstrated prognostic relevance for CRC akin to other precursors including conventional adenoma and serrated polyps
Bowel lavage a standard practice for facilitating colonoscopies may affect the interaction between gut microbes and intestinal phenotypes Standard bowel preparations have immediate impacts on gut microbiota composition with alterations typically lasting around 14 days before a partial return to baseline These changes in gut microbial diversity likely contribute to minor colonoscopy complications such as abdominal discomfort bloating diarrhea and constipation during the recovery period
Post-bowel lavage dietary intervention could potentially minimize lavage-associated side effects by promoting microbial diversity restoration and systemic inflammation reduction In a previous mouse study the investigators discovered that the Standard American Diet SAD led to the proliferation of opportunistic pathogens following surgical lavage This change in microbial composition was linked to increased systemic inflammation and a higher incidence of surgical complications Additionally they observed that a high-fiber low-saturated-fat diet-like a whole food plant-based WFPB MedDASH diet and modified Mediterranean diet-can reverse this inflammatory phenotype
However there is a lack of interventional trials investigating the health benefits of specific dietary interventions following bowel lavage Therefore the investigators propose a human intervention study to assess if daily consumption of a high-fiber diet after colonoscopy will alter the intestinal microbiota decrease inflammation and improve digestive health
This will be a controlled intervention study involving 30 subjects who will be enrolled on a rolling basis as they are identified during the recruitment period The study begins with an initial visit at Week 1 where blood is collected for immune profiling and metabolomics and participants start weekly stool collection using the S-Wipe method At Week 2 a GutLab device is installed in participants homes for daily stool collection The colonoscopy occurs at Week 4 followed by a 2-week high-fiber diet provided by Thistle Throughout the study blood draws 6 mL are performed at Weeks 1 4 6 and 8 while stool samples are collected weekly via S-Wipe and daily via GutLab Participants log their food intake with a dietitian three times per week during Weeks 3 5 and 7 and body composition measurements are taken before the colonoscopy and at the final visit The study aims to quantify how dietary intervention affects post-lavage microbiome metabolome and immune response through analysis of blood and stool samples Optional follow-ups at 1 3 and 5 years will assess polyp recurrence This design enables a comprehensive assessment of a high-fiber diets impact on intestinal microbiota inflammation and digestive health in individuals with a history of polyps undergoing colonoscopy
Bowel lavage a standard practice for facilitating colonoscopies may affect the interaction between gut microbes and intestinal phenotypes Standard bowel preparations have immediate impacts on gut microbiota composition with alterations typically lasting around 14 days before a partial return to baseline These changes in gut microbial diversity likely contribute to minor colonoscopy complications such as abdominal discomfort bloating diarrhea and constipation during the recovery period
Post-bowel lavage dietary intervention could potentially minimize lavage-associated side effects by promoting microbial diversity restoration and systemic inflammation reduction In a previous mouse study the investigators discovered that the Standard American Diet SAD led to the proliferation of opportunistic pathogens following surgical lavage This change in microbial composition was linked to increased systemic inflammation and a higher incidence of surgical complications Additionally they observed that a high-fiber low-saturated-fat diet-like a whole food plant-based WFPB MedDASH diet and modified Mediterranean diet-can reverse this inflammatory phenotype
However there is a lack of interventional trials investigating the health benefits of specific dietary interventions following bowel lavage Therefore the investigators propose a human intervention study to assess if daily consumption of a high-fiber diet after colonoscopy will alter the intestinal microbiota decrease inflammation and improve digestive health
This will be a controlled intervention study involving 30 subjects who will be enrolled on a rolling basis as they are identified during the recruitment period The study begins with an initial visit at Week 1 where blood is collected for immune profiling and metabolomics and participants start weekly stool collection using the S-Wipe method At Week 2 a GutLab device is installed in participants homes for daily stool collection The colonoscopy occurs at Week 4 followed by a 2-week high-fiber diet provided by Thistle Throughout the study blood draws 6 mL are performed at Weeks 1 4 6 and 8 while stool samples are collected weekly via S-Wipe and daily via GutLab Participants log their food intake with a dietitian three times per week during Weeks 3 5 and 7 and body composition measurements are taken before the colonoscopy and at the final visit The study aims to quantify how dietary intervention affects post-lavage microbiome metabolome and immune response through analysis of blood and stool samples Optional follow-ups at 1 3 and 5 years will assess polyp recurrence This design enables a comprehensive assessment of a high-fiber diets impact on intestinal microbiota inflammation and digestive health in individuals with a history of polyps undergoing colonoscopy
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