Microscopic ColitisCMBACTNCT06172647
Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer
An observational study of Microscopic Colitis and Colorectal Cancer, run by Hospital Mutua de Terrassa at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microscopic Colitis, Colorectal Cancer, Colon Adenoma
- What is being tested?
- Colonoscopy
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from participating centers that require a colonoscopy for standard clinical practice (study of chronic watery diarrhoea, treatment of colon adenomas or population screening with a positive faecal occult blood test)
Who may be able to join
- 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 for minimum 3 times a week and lasting at least 1 month.
- 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.
- Signing of the informed consent.
- Patients with Advanced Colon Adenomas
Show all 11Show fewer
- Age between 50 and 70 years.
- 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.
- 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.
Who cannot join
- Pregnancy or breastfeeding.
- 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).
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari MútuaTerrassa
Terrassa, Barcelona, 08221
Yamile Zabana, MD, PhD, yzabana@gmail.com
About this study
Official title: Intestinal Microbiome Adherent to the Mucosa in Microscopic Colitis in Comparison With Patients With Advanced Colon Adenomas
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.
Read more
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.
- Conditions
- Microscopic Colitis, Colorectal Cancer, Colon Adenoma
- Being tested
- Colonoscopy
- Keywords
- intestinal microbiome, mucosal adherent bacteria, dysbiosis, precancerous lesion
- Medical subject headings
- Colitis, Microscopic, Colorectal Neoplasms, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Active Microscopic Colitis (MC) patients | Not described Receives: Diagnostic Test: Colonoscopy | |
| Chronic watery diarrhoea patients | Not described Receives: Diagnostic Test: Colonoscopy | |
| Patients with Advanced Colon Adenomas | Not described Receives: Diagnostic Test: Colonoscopy | |
| Healthy controls | Not described Receives: Diagnostic Test: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion and abundance of bacterial taxa (defined as total percentage of bacterial DNA sequences)
Measured: at inclusion (colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jun 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Microscopic ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172647
- Sponsor's protocol ID
- P/22-066
- Acronym
- CMBACT
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33619914Jarnerot 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.
PubMed 7615194Rindom 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.
PubMed 31009268Morgan 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.
PubMed 31254673Shobar 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.
PubMed 26866392Drago 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.
PubMed 31358483Batista 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.
PubMed 35764931Aprile 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.
PubMed 34205378
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiome Adherent to the Mucosa in Microscopic Colitis in Comparison With Patients With Advanced Colon Adenomas
- ClinicalTrials.gov ID
- NCT06172647
- Acronym / sponsor ID
- CMBACT / P/22-066
- Conditions
- Microscopic Colitis, Colorectal Cancer, Colon Adenoma
- Keywords
- intestinal microbiome, mucosal adherent bacteria, dysbiosis, precancerous lesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Microscopic Colitis (MC) patients | – | Diagnostic Test: Colonoscopy |
| Chronic watery diarrhoea patients | – | Diagnostic Test: Colonoscopy |
| Patients with Advanced Colon Adenomas | – | Diagnostic Test: Colonoscopy |
| Healthy controls | – | Diagnostic Test: Colonoscopy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from participating centers that require a colonoscopy for standard clinical practice (study of chronic watery diarrhoea, treatment of colon adenomas or population screening with a positive faecal occult blood test)
Key inclusion criteria (11 listed)
- 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 for minimum 3 times a week and lasting at least 1 month.
- 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.
- Signing of the informed consent.
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColonoscopyEndoscopic 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) | Diagnostic test | Active Microscopic Colitis (MC) patients, Chronic watery diarrhoea patients, Healthy controls, Patients with Advanced Colon Adenomas |
Primary outcome
Proportion and abundance of bacterial taxa (defined as total percentage of bacterial DNA sequences)
Time frame: at inclusion (colonoscopy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 33619914Miehlke 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.
- Background: PubMed 7615194Jarnerot 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.
- Background: PubMed 31009268Rindom 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.
- Background: PubMed 31254673Morgan 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.
- Background: PubMed 26866392Shobar 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.
- Background: PubMed 31358483Drago 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.
- Background: PubMed 35764931Batista 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.
- Background: PubMed 34205378Aprile 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microscopic Colitis and Colorectal Cancer, run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion and abundance of bacterial taxa (defined as total percentage of bacterial DNA sequences) (time frame: at inclusion (colonoscopy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172647, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.