Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer

NCT ID: NCT06172647

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microscopic Colitis Colorectal Cancer Colon Adenoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intestinal microbiome mucosal adherent bacteria dysbiosis precancerous lesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Microscopic Colitis (MC) patients

Colonoscopy

Intervention Type DIAGNOSTIC_TEST

Endoscopic exploration of the colon (colonoscopy) for standard clinical practice (study of chronic watery diarrhoea, treatment of colon adenomas or population screening with a positive faecal occult blood test)

Chronic watery diarrhoea patients

Colonoscopy

Intervention Type DIAGNOSTIC_TEST

Endoscopic exploration of the colon (colonoscopy) for standard clinical practice (study of chronic watery diarrhoea, treatment of colon adenomas or population screening with a positive faecal occult blood test)

Patients with Advanced Colon Adenomas

Colonoscopy

Intervention Type DIAGNOSTIC_TEST

Endoscopic exploration of the colon (colonoscopy) for standard clinical practice (study of chronic watery diarrhoea, treatment of colon adenomas or population screening with a positive faecal occult blood test)

Healthy controls

Colonoscopy

Intervention Type DIAGNOSTIC_TEST

Endoscopic exploration of the colon (colonoscopy) for standard clinical practice (study of chronic watery diarrhoea, treatment of colon adenomas or population screening with a positive faecal occult blood test)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colonoscopy

Endoscopic exploration of the colon (colonoscopy) for standard clinical practice (study of chronic watery diarrhoea, treatment of colon adenomas or population screening with a positive faecal occult blood test)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Mutua de Terrassa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitari MútuaTerrassa

Terrassa, Barcelona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yamile Zabana, MD, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Miehlke S, Guagnozzi D, Zabana Y, Tontini GE, Kanstrup Fiehn AM, Wildt S, Bohr J, Bonderup O, Bouma G, D'Amato M, Heiberg Engel PJ, Fernandez-Banares F, Macaigne G, Hjortswang H, Hultgren-Hornquist E, Koulaouzidis A, Kupcinskas J, Landolfi S, Latella G, Lucendo A, Lyutakov I, Madisch A, Magro F, Marlicz W, Mihaly E, Munck LK, Ostvik AE, Patai AV, Penchev P, Skonieczna-Zydecka K, Verhaegh B, Munch A. European guidelines on microscopic colitis: United European Gastroenterology and European Microscopic Colitis Group statements and recommendations. United European Gastroenterol J. 2021 Feb 22;9(1):13-37. doi: 10.1177/2050640620951905. Online ahead of print.

Reference Type BACKGROUND
PMID: 33619914 (View on PubMed)

Jarnerot G, Tysk C, Bohr J, Eriksson S. Collagenous colitis and fecal stream diversion. Gastroenterology. 1995 Aug;109(2):449-55. doi: 10.1016/0016-5085(95)90332-1.

Reference Type BACKGROUND
PMID: 7615194 (View on PubMed)

Rindom Krogsgaard L, Kristian Munck L, Bytzer P, Wildt S. An altered composition of the microbiome in microscopic colitis is driven towards the composition in healthy controls by treatment with budesonide. Scand J Gastroenterol. 2019 Apr;54(4):446-452. doi: 10.1080/00365521.2019.1599064. Epub 2019 Apr 22.

Reference Type BACKGROUND
PMID: 31009268 (View on PubMed)

Morgan DM, Cao Y, Miller K, McGoldrick J, Bellavance D, Chin SM, Halvorsen S, Maxner B, Richter JM, Sassi S, Burke KE, Yarze JC, Ludvigsson JF, Staller K, Chung DC, Khalili H. Microscopic Colitis Is Characterized by Intestinal Dysbiosis. Clin Gastroenterol Hepatol. 2020 Apr;18(4):984-986. doi: 10.1016/j.cgh.2019.06.035. Epub 2019 Jun 27.

Reference Type BACKGROUND
PMID: 31254673 (View on PubMed)

Shobar RM, Velineni S, Keshavarzian A, Swanson G, DeMeo MT, Melson JE, Losurdo J, Engen PA, Sun Y, Koenig L, Mutlu EA. The Effects of Bowel Preparation on Microbiota-Related Metrics Differ in Health and in Inflammatory Bowel Disease and for the Mucosal and Luminal Microbiota Compartments. Clin Transl Gastroenterol. 2016 Feb 11;7(2):e143. doi: 10.1038/ctg.2015.54.

Reference Type BACKGROUND
PMID: 26866392 (View on PubMed)

Drago L, Valentina C, Fabio P. Gut microbiota, dysbiosis and colon lavage. Dig Liver Dis. 2019 Sep;51(9):1209-1213. doi: 10.1016/j.dld.2019.06.012. Epub 2019 Jul 27.

Reference Type BACKGROUND
PMID: 31358483 (View on PubMed)

Batista L, Robles V, Manichanh C, Ruiz L, Guagnozzi D, Pinsach F, Guarner F, Fernandez-Banares F. Colonic bacterial diversity and dysbiosis in active microscopic colitis as compared to chronic diarrhoea and healthy controls: effect of polyethylene glycol after bowel lavage for colonoscopy. BMC Gastroenterol. 2022 Jun 28;22(1):320. doi: 10.1186/s12876-022-02392-w.

Reference Type BACKGROUND
PMID: 35764931 (View on PubMed)

Aprile F, Bruno G, Palma R, Mascellino MT, Panetta C, Scalese G, Oliva A, Severi C, Pontone S. Microbiota Alterations in Precancerous Colon Lesions: A Systematic Review. Cancers (Basel). 2021 Jun 19;13(12):3061. doi: 10.3390/cancers13123061.

Reference Type BACKGROUND
PMID: 34205378 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P/22-066

Identifier Type: -

Identifier Source: org_study_id