Investigating the intestinal microbiome in patients with microscopic colitis and colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Universitari MútuaTerrassa
  Terrassa, Barcelona, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.