Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer

Launched by HOSPITAL MUTUA DE TERRASSA · Dec 7, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the role of the intestinal microbiome—tiny organisms living in our intestines—in patients with microscopic colitis (MC), a condition that causes chronic watery diarrhea, and those with advanced colon adenomas, which are growths that can lead to colorectal cancer. Researchers want to understand how the bacteria that stick to the gut's surface differ between people with MC, those with other types of chronic diarrhea, healthy individuals, and patients with colon adenomas. They will also collect information about participants' demographics, medication history, diet, and diarrhea characteristics to see if these factors influence the microbiome.

To be eligible for the study, you need to be at least 45 years old for women and 60 for men, have chronic watery diarrhea without blood for at least a month, and have normal blood test results. Alternatively, if you're between 50 and 70 years old and have advanced colon adenomas or are healthy with no significant colon issues, you might qualify too. Participants can expect to provide stool samples and undergo a colonoscopy, which is a procedure to examine the colon. This study is important because it may reveal specific bacterial patterns related to both microscopic colitis and colorectal cancer risk, helping doctors better understand and potentially treat these conditions.

Gender

ALL

Eligibility 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