Last updated: December 7, 2023
Sponsor: Hospital Mutua de Terrassa
Overall Status: Active - Recruiting
Phase
N/A
Condition
Colorectal Cancer
Inflammatory Bowel Disease
Rectal Cancer
Treatment
Colonoscopy
Clinical Study ID
NCT06172647
P/22-066
Ages > 45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: MC and Chronic watery diarrhea patients
- Women ≥ 45 years old / Men ≥ 60 years old.
- Patient with chronic watery diarrhea without blood with ≥2 liquid stools per day forminimum 3 times a week and lasting at least 1 month.
- Blood analysis values within normality, with negative celiac disease serology andabsence of acute phase reactants (normal C-reactive protein) and normal thyroidhormones. Calprotectin values may be elevated.
- Signing of the informed consent. Patients with Advanced Colon Adenomas
- Age between 50 and 70 years.
- Population screening participants with polyps with a crypt pattern of adenomatousappearance and polyp size of ≥10mm, or patients referred for endoscopic treatment ofadvanced adenomas.
- Signing of the informed consent. Healthy controls
- Age between 50 and 70 years. 2. Participants in the population screening with normalcolonoscopy (without endoscopic alterations except presence of < 5 polyps (all less than 10mm) and/or colonic diverticulosis (except multiple diverticula in the sigma)). 3. Signingof the informed consent.
Exclusion
Exclusion Criteria:
- Pregnancy or breastfeeding.
- Patients who have received antibiotic, probiotic or prebiotic treatment in the 3months prior to the study. 3. Patients who have traveled to developing orunderdeveloped countries in the 3 months prior to the start of the study.
- Patients who have received immunosuppressants and corticosteroids in the 3 months priorto the start of the study.
- Patients who have received radiotherapy and/or chemotherapy in the 6 months prior to thestart of the study.
- Consumption of herbal products. 7. Bacterial or parasitic intestinal infection (including Blastocystis hominis).
- History of inflammatory bowel disease or celiac disease. 9. Previous gastrointestinalsurgery (excluding appendectomy or inguinal hernia repair).
- Incomplete colonoscopy or lack of biopsies of the right, transverse and left colon.
- Unsatisfactory preparation for a complete examination (Boston scale <6, any segment <2).
- Inability to understand the instructions involved in participating in this study
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Colonoscopy
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
June 30, 2025
Connect with a study center
Hospital Universitari MútuaTerrassa
Terrassa, Barcelona 08221
SpainActive - Recruiting
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