Investigating the intestinal microbiome in patients with microscopic colitis and colorectal cancer
Intestinal Microbiome Adherent to the Mucosa in Microscopic Colitis in Comparison With Patients With Advanced Colon Adenomas
This study is trying to see how the bacteria in the gut might be linked to microscopic colitis and colorectal cancer in people who have these conditions, as well as in healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Hospital Mutua de Terrassa Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Terrassa, Barcelona) |
| Trial ID | NCT06172647 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of the mucosa adherent intestinal microbiome in patients diagnosed with microscopic colitis, colorectal cancer, and advanced colon adenomas. It will involve patients undergoing colonoscopy, where biopsies will be taken to analyze the microbiome composition and its potential link to disease pathogenesis. The study will include patients with chronic watery diarrhea, advanced adenomas, and healthy controls to compare microbiome profiles. The findings may provide insights into the relationship between dysbiosis and these gastrointestinal conditions.
Who should consider this trial
Good fit: Ideal candidates include women aged 45 and older or men aged 60 and older with chronic watery diarrhea or patients aged 50 to 70 with advanced colon adenomas.
Not a fit: Patients with conditions unrelated to microscopic colitis or colorectal cancer, or those outside the specified age ranges, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the microbiome's role in gastrointestinal diseases, potentially leading to improved diagnostic and therapeutic strategies.
How similar studies have performed: Previous studies have indicated changes in the microbiome associated with gastrointestinal diseases, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: MC and Chronic watery diarrhea patients 1. Women ≥ 45 years old / Men ≥ 60 years old. 2. Patient with chronic watery diarrhea without blood with ≥2 liquid stools per day for minimum 3 times a week and lasting at least 1 month. 3. Blood analysis values within normality, with negative celiac disease serology and absence of acute phase reactants (normal C-reactive protein) and normal thyroid hormones. Calprotectin values may be elevated. 4. Signing of the informed consent. Patients with Advanced Colon Adenomas 1. Age between 50 and 70 years. 2. Population screening participants with polyps with a crypt pattern of adenomatous appearance and polyp size of ≥10mm, or patients referred for endoscopic treatment of advanced adenomas. 3. Signing of the informed consent. Healthy controls 1. Age between 50 and 70 years. 2. Participants in the population screening with normal colonoscopy (without endoscopic alterations except presence of \< 5 polyps (all less than 10mm) and/or colonic diverticulosis (except multiple diverticula in the sigma)). 3. Signing of the informed consent. Exclusion Criteria: 1. Pregnancy or breastfeeding. 2. Patients who have received antibiotic, probiotic or prebiotic treatment in the 3 months prior to the study. 3. Patients who have traveled to developing or underdeveloped countries in the 3 months prior to the start of the study. 4. Patients who have received immunosuppressants and corticosteroids in the 3 months prior to the start of the study. 5. Patients who have received radiotherapy and/or chemotherapy in the 6 months prior to the start of the study. 6. Consumption of herbal products. 7. Bacterial or parasitic intestinal infection (including Blastocystis hominis). 8. History of inflammatory bowel disease or celiac disease. 9. Previous gastrointestinal surgery (excluding appendectomy or inguinal hernia repair). 10. Incomplete colonoscopy or lack of biopsies of the right, transverse and left colon. 11. Unsatisfactory preparation for a complete examination (Boston scale \<6, any segment \<2). 12. Inability to understand the instructions involved in participating in this study
Where this trial is running
Terrassa, Barcelona
- Hospital Universitari MútuaTerrassa — Terrassa, Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.