Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172647
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Brief Title:
Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer
Sponsor:
Hospital Mutua de Terrassa
Organization:
Hospital Mutua de Terrassa
Study Overview
Official Title:
Intestinal Microbiome Adherent to the Mucosa in Microscopic Colitis in Comparison With Patients With Advanced Colon Adenomas
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMBACT
Brief Summary:
Microscopic colitis MC is an inflammatory bowel disease characterized by chronic non-bloody watery diarrhoea and a macroscopically normal colonic mucosa upon endoscopic exploration colonoscopy The diagnosis is performed by microscopic examination of mucosal biopsies that reveal specific histopathological change Between 4-20 of patients with chronic non-bloody diarrhoea who undergo colonoscopy with serial biopsies are diagnosed with MC
It has long been hypothesized that the microbiome plays a key role in the pathogenesis of MC In patients with collagenous colitis faecal stream diversion results in inflammation and histological remission followed by disease relapse after intestinal transit is reconstructed Moreover studies carried out with faecal samples obtained after colonoscopy have demonstrated microbiome changes reduced alpha diversity and higher microbial dysbiosis index in patients with active MC To avoid potential bias due to the effect of colonic lavage prior to colonoscopy in microbiota composition the researchers of the present study previously evaluated the microbiome in faecal samples obtained before the diagnostic colonoscopy in patients with active MC The results confirmed a reduced alpha diversity in diarrhoea groups however there were no differences between MC bile-acid diarrhoea and functional diarrhoea The microbial dysbiosis index was significantly higher in MC compared to the other diarrheal groups but no bacterial species showed a significantly different relative abundance On the other hand the risk of colorectal cancer CRC or adenoma seems to be reduced in MC compared to controls Growing evidence suggests microbial dysbiosis is a crucial environmental factor in the initiation of precancerous lesions of CRC such as adenomas
The objective of the current multicentric prospective study is to assess the differences in the mucosa adherent intestinal microbiome between patients with MC non-MC chronic diarrhoea healthy controls and patients with advanced colon adenomas In addition to the study of the microbiome sociodemographic variables history of drug usage diets and specific characteristics of diarrhoea will be collected
The hypothesis of the present study is that CM presents a specific mucosa adherent intestinal bacterial profile that may be relevant in the pathogenesis of the disease and that additionally may also play a protective role against the development of CRC and adenomas
It has long been hypothesized that the microbiome plays a key role in the pathogenesis of MC In patients with collagenous colitis faecal stream diversion results in inflammation and histological remission followed by disease relapse after intestinal transit is reconstructed Moreover studies carried out with faecal samples obtained after colonoscopy have demonstrated microbiome changes reduced alpha diversity and higher microbial dysbiosis index in patients with active MC To avoid potential bias due to the effect of colonic lavage prior to colonoscopy in microbiota composition the researchers of the present study previously evaluated the microbiome in faecal samples obtained before the diagnostic colonoscopy in patients with active MC The results confirmed a reduced alpha diversity in diarrhoea groups however there were no differences between MC bile-acid diarrhoea and functional diarrhoea The microbial dysbiosis index was significantly higher in MC compared to the other diarrheal groups but no bacterial species showed a significantly different relative abundance On the other hand the risk of colorectal cancer CRC or adenoma seems to be reduced in MC compared to controls Growing evidence suggests microbial dysbiosis is a crucial environmental factor in the initiation of precancerous lesions of CRC such as adenomas
The objective of the current multicentric prospective study is to assess the differences in the mucosa adherent intestinal microbiome between patients with MC non-MC chronic diarrhoea healthy controls and patients with advanced colon adenomas In addition to the study of the microbiome sociodemographic variables history of drug usage diets and specific characteristics of diarrhoea will be collected
The hypothesis of the present study is that CM presents a specific mucosa adherent intestinal bacterial profile that may be relevant in the pathogenesis of the disease and that additionally may also play a protective role against the development of CRC and adenomas
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None