Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT05891756
Status:
RECRUITING
Last Update Posted:
2023-06-22
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mesenteric Bacterial Translocation in Evolved Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Mesenteric fat, ileal tissue and whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-19', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in the proportions and abundance of bacterial taxa (defined as total percentage of bacterial DNA sequences) between the mesentery, ileal tissue and blood between CD patients with and without early post-surgical disease recurrence', 'timeFrame': 'at inclusion (surgery)'}, {'measure': 'Differences in the function of the bacterial profile (defined as the metagenome function analysis) between the mesentery, ileal tissue and blood between CD patients with and without early post-surgical disease recurrence', 'timeFrame': 'at inclusion (surgery)'}], 'secondaryOutcomes': [{'measure': 'Association analysis of genetic variants related to innate immunity and the bacterial microbiome profile of CD patients', 'timeFrame': 'at inclusion (surgery)', 'description': 'DNA polymorphisms detection in blood: ATG16L1 (rs2241880, rs3792109, rs3828309); NOD2 / CARD15 (rs2066844, rs2066845) and IRGM (rs13361189, rs4958847, rs1336119, rs10065172, rs7714584).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Crohn Disease', 'Mesenteric fat', 'Bacterial translocation', 'Innate immunity', 'Genetic polymorphisms'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '20434953', 'type': 'BACKGROUND', 'citation': 'Schaffler A, Scholmerich J. Innate immunity and adipose tissue biology. Trends Immunol. 2010 Jun;31(6):228-35. doi: 10.1016/j.it.2010.03.001.'}, {'pmid': '22569302', 'type': 'BACKGROUND', 'citation': 'Batra A, Heimesaat MM, Bereswill S, Fischer A, Glauben R, Kunkel D, Scheffold A, Erben U, Kuhl A, Loddenkemper C, Lehr HA, Schumann M, Schulzke JD, Zeitz M, Siegmund B. Mesenteric fat - control site for bacterial translocation in colitis? Mucosal Immunol. 2012 Sep;5(5):580-91. doi: 10.1038/mi.2012.33. Epub 2012 May 9.'}, {'pmid': '20625283', 'type': 'BACKGROUND', 'citation': "Bertin B, Desreumaux P, Dubuquoy L. Obesity, visceral fat and Crohn's disease. Curr Opin Clin Nutr Metab Care. 2010 Sep;13(5):574-80. doi: 10.1097/MCO.0b013e32833cf0f4."}, {'pmid': '2222015', 'type': 'BACKGROUND', 'citation': 'Alexander JW, Boyce ST, Babcock GF, Gianotti L, Peck MD, Dunn DL, Pyles T, Childress CP, Ash SK. The process of microbial translocation. Ann Surg. 1990 Oct;212(4):496-510; discussion 511-2. doi: 10.1097/00000658-199010000-00012.'}, {'pmid': '1478405', 'type': 'BACKGROUND', 'citation': 'Laffineur G, Lescut D, Vincent P, Quandalle P, Wurtz A, Colombel JF. [Bacterial translocation in Crohn disease]. Gastroenterol Clin Biol. 1992;16(10):777-81. French.'}, {'pmid': '21930728', 'type': 'BACKGROUND', 'citation': "Zulian A, Cancello R, Micheletto G, Gentilini D, Gilardini L, Danelli P, Invitti C. Visceral adipocytes: old actors in obesity and new protagonists in Crohn's disease? Gut. 2012 Jan;61(1):86-94. doi: 10.1136/gutjnl-2011-300391. Epub 2011 Sep 19."}, {'pmid': '17053832', 'type': 'BACKGROUND', 'citation': 'Shi H, Kokoeva MV, Inouye K, Tzameli I, Yin H, Flier JS. TLR4 links innate immunity and fatty acid-induced insulin resistance. J Clin Invest. 2006 Nov;116(11):3015-25. doi: 10.1172/JCI28898. Epub 2006 Oct 19.'}, {'pmid': '22068165', 'type': 'BACKGROUND', 'citation': "Siegmund B. Mesenteric fat in Crohn's disease: the hot spot of inflammation? Gut. 2012 Jan;61(1):3-5. doi: 10.1136/gutjnl-2011-301354. Epub 2011 Nov 7. No abstract available."}, {'pmid': '31142586', 'type': 'BACKGROUND', 'citation': "Sokol H, Brot L, Stefanescu C, Auzolle C, Barnich N, Buisson A, Fumery M, Pariente B, Le Bourhis L, Treton X, Nancey S, Allez M, Seksik P; REMIND Study Group Investigators. Prominence of ileal mucosa-associated microbiota to predict postoperative endoscopic recurrence in Crohn's disease. Gut. 2020 Mar;69(3):462-472. doi: 10.1136/gutjnl-2019-318719. Epub 2019 May 29."}, {'pmid': '18183602', 'type': 'BACKGROUND', 'citation': "Domenech E, Manosa M, Bernal I, Garcia-Planella E, Cabre E, Pinol M, Lorenzo-Zuniga V, Boix J, Gassull MA. Impact of azathioprine on the prevention of postoperative Crohn's disease recurrence: results of a prospective, observational, long-term follow-up study. Inflamm Bowel Dis. 2008 Apr;14(4):508-13. doi: 10.1002/ibd.20359."}, {'pmid': '23376290', 'type': 'BACKGROUND', 'citation': "Gutierrez A, Scharl M, Sempere L, Holler E, Zapater P, Almenta I, Gonzalez-Navajas JM, Such J, Wiest R, Rogler G, Frances R. Genetic susceptibility to increased bacterial translocation influences the response to biological therapy in patients with Crohn's disease. Gut. 2014 Feb;63(2):272-80. doi: 10.1136/gutjnl-2012-303557. Epub 2013 Feb 1."}, {'pmid': '25555386', 'type': 'BACKGROUND', 'citation': "Li Y, Zuo L, Zhu W, Gong J, Zhang W, Gu L, Guo Z, Li N, Li J. The impact of bacterial DNA translocation on early postoperative outcomes in Crohn's patients undergoing abdominal surgery. J Crohns Colitis. 2015 Mar;9(3):259-65. doi: 10.1093/ecco-jcc/jju029. Epub 2015 Jan 2."}, {'pmid': '12473892', 'type': 'BACKGROUND', 'citation': "Takesue Y, Ohge H, Uemura K, Imamura Y, Murakami Y, Yokoyama T, Kakehashi M, Sueda T. Bacterial translocation in patients with Crohn's disease undergoing surgery. Dis Colon Rectum. 2002 Dec;45(12):1665-71. doi: 10.1007/s10350-004-7256-z."}, {'pmid': '20232407', 'type': 'BACKGROUND', 'citation': "Kosovac K, Brenmoehl J, Holler E, Falk W, Schoelmerich J, Hausmann M, Rogler G. Association of the NOD2 genotype with bacterial translocation via altered cell-cell contacts in Crohn's disease patients. Inflamm Bowel Dis. 2010 Aug;16(8):1311-21. doi: 10.1002/ibd.21223."}, {'pmid': '30239655', 'type': 'BACKGROUND', 'citation': "Kiernan MG, Coffey JC, McDermott K, Cotter PD, Cabrera-Rubio R, Kiely PA, Dunne CP. The Human Mesenteric Lymph Node Microbiome Differentiates Between Crohn's Disease and Ulcerative Colitis. J Crohns Colitis. 2019 Jan 1;13(1):58-66. doi: 10.1093/ecco-jcc/jjy136."}]}, 'descriptionModule': {'briefSummary': "Mesenteric fat can be invaded by gut bacteria through a process called bacterial translocation, which is the invasion of viable bacteria from the gastrointestinal tract to extraintestinal sites (mesenteric lymph nodes, liver, spleen, kidney, bloodstream, etc.). In Crohn's disease (CD), bacterial translocation could increase the disproportionate inflammatory response already present and contribute to disease progression by stimulating the production of pro-inflammatory cytokines and immune-cell infiltration in the mesentery. Several mechanisms may promote bacterial translocation, such as bacterial overgrowth, disruption of the intestinal mucosal barrier and alterations in the immune system.\n\nIleocecal surgical resection is required in some patients with complicated or refractory CD. Unfortunately, post-surgical disease recurrence happens in up to 40% of cases, probably defining a subgroup of CD patients with a particular aggressive form of the disease. The complete microbiome (in gastrointestinal and extraintestinal sites) in CD patients that develop early post-surgical recurrence, as well as the association to innate immunity alterations, has not yet been studied.\n\nThe primary aim of the study is to explore the bacterial microbiome of CD patients and its association with early post-surgical recurrence and clinical or genetic variables related to innate immunity. To achieve this, the bacterial DNA present in mesenteric fat and ileal tissue (inflamed and non-inflamed) from surgical resection samples as well as blood samples from CD patients will be studied. Genetic polymorphisms, relevant clinical data and disease recurrence will also be evaluated.\n\nThe investigators hypothesize that bacterial translocation to the mesentery fat near the inflamed intestine is one of the mechanisms for perpetuation and chronicity of inflammation and therefore post-surgical recurrence in CD. The investigators expect to find a distinctive bacterial profile (in quantity and quality) in the mesenteric fat of patients with early post-surgical recurrence and/or with genetic variants that cause alterations in innate immunity.\n\nThe study of the microbiome in CD could help to identify the patients with a more aggressive disease form that will probably present early post-surgical recurrence, and could raise the possibility of microbial modulation as therapy for CD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the Hospital Universitari MútuaTerrassa', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (18 years or older)\n* Informed consent signed\n* To require an ileocecal resection as part of the treatment of Crohn's Disease\n* In the case of controls: not having Inflammatory Bowel Disease and requiring an ileocecal resection for another reason\n\nExclusion Criteria:\n\n* To require an ileocecal resection with definitive or transient ileostomy\n* In the case of controls: existence of a family history of Inflammatory Bowel Disease."}, 'identificationModule': {'nctId': 'NCT05891756', 'acronym': 'MESENCROHN', 'briefTitle': "Mesenteric Bacterial Translocation in Evolved Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Hospital Mutua de Terrassa'}, 'officialTitle': "Mesenteric Bacterial Translocation in Evolved Crohn's Disease", 'orgStudyIdInfo': {'id': 'MESENCROHN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CD patients requiring surgical treatment (ileocecal resection)'}, {'label': 'Control group', 'description': 'Patients requiring an ileocecal resection for a cause other than CD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari MútuaTerrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'centralContacts': [{'name': 'Yamile Zabana, MD, PhD', 'role': 'CONTACT', 'email': 'yzabana@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Mutua de Terrassa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}