Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-22 @ 3:02 AM
Study NCT ID:
NCT02857257
Status:
UNKNOWN
Last Update Posted:
2018-08-08
First Post:
2016-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2016-07-26', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom relief according to irritable bowel syndrome-symptom severity scale (IBS-SSS)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Differential bacterial species population as defined by 16S RNA', 'timeFrame': '4 weeks', 'description': 'Description of different bacterial species harboring in fecal samples before and after treatment with ACHIM. Exploratory outcome measure.'}, {'measure': 'Normalization of stool consistency as determined by the Bristol stool scale', 'timeFrame': '4 weeks', 'description': 'Normalization as determined by the Bristol stool scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS', 'Microbiota'], 'conditions': ['Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '9146781', 'type': 'RESULT', 'citation': 'Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.'}, {'pmid': '9299672', 'type': 'RESULT', 'citation': 'Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.'}, {'pmid': '24018052', 'type': 'RESULT', 'citation': 'Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.'}, {'pmid': '31594647', 'type': 'DERIVED', 'citation': 'Benno P, Norin E, Midtvedt T, Hellstrom PM. Therapeutic potential of an anaerobic cultured human intestinal microbiota, ACHIM, for treatment of IBS. Best Pract Res Clin Gastroenterol. 2019 Jun-Aug;40-41:101607. doi: 10.1016/j.bpg.2019.03.003. Epub 2019 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'Patients with irritable bowel syndrome (IBS) are treated with microbiota from a human intestinal anaerobic sample cultured for decades. Patients are recruited consecutively with symptoms of IBS and serve as their own controls. After an observation time of 4 weeks, patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by the duodenal route via gastroscopy. Two treatments are given within a 1-week interval. Assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks). Additionally, fecal samples are collected for bacterial 16S ribosomal ribonucleic acid (rRNA) analysis and bacterial functional parameters (microflora-associated characteristics).', 'detailedDescription': "Diarrhea-dominated irritable bowel syndrome (IBS-D) is studied in subjects by treatment with an anaerobic human intestinal microbiota cultured for 15 years and quality controlled with a specified content of bacterial species regularly over the years. Inclusion criteria is: Diarrheal disease since at least 4 weeks, 18-80 years of age, previously unsuccessful treatment with no symptomatic relief of antidiarrheals or resins, and signed informed consent.\n\nPrimary outcome was irritable bowel syndrome-symptom severity scale (IBS-SSS). Secondary outcome was Bristol stool scale (BSS).\n\nSecondary outcome: Changes in fecal microflora distribution and multiplicity as shown by the 16S ribosomal ribonucleic acid (rRNA) analysis of feces.\n\nOnce eligible for the study, patients were monitored for a run-in period of one week with the IBS-SSS and the BSS plus fecal samples for analysis of bacterial species using the bacterial specific 16S rRNA differentiation.\n\nThen, the anaerobic cultured human intestinal microflora (ACHIM) was given twice with an interval of 1 week. Thereafter, patients were further monitored over 4 weeks as regards IBS-SSS and BSS. Another feces sample was also collected for bacterial 16S rRNA analysis to evaluate the microbiota diversity.\n\nThe study will be evaluated using eligible subjects as their own controls by means of Wilcoxon's matched-pairs test, alternatively t-test for matched pairs.\n\nPower analysis show that 40 subjects are needed to study in order to achieve a power of 80%."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBS according to the Rome III criteria\n\nExclusion Criteria:\n\n* Pregnancy\n* Antibiotic and probiotics within 8 weeks before inclusion\n* Unable to give informed consent\n* Immunodeficiency (drug- och disease-related)'}, 'identificationModule': {'nctId': 'NCT02857257', 'acronym': 'ACHIM2', 'briefTitle': 'Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'ACHIM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Only one treatment arm. Patients are allocated under disease condition and later treated with ACHIM. The post-treatment disease progression is monitored.', 'interventionNames': ['Biological: ACHIM']}], 'interventions': [{'name': 'ACHIM', 'type': 'BIOLOGICAL', 'otherNames': ['Anaerobic cultured human intestinal microbiota'], 'description': 'After an observation period of 4 weeks patients with IBS-D will be treated with ACHIM', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11157', 'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Peter Benno, MD, PhD', 'role': 'CONTACT', 'email': 'Peter.Benno@endoskopienheten.se', 'phone': '+46 7055795554'}, {'name': 'Per Hellström, MD; PhD', 'role': 'CONTACT', 'email': 'Per.Hellstrom@medsci.uu.se', 'phone': '+46 70 3727423'}], 'facility': 'Mag-tarm/endoskopienheten Hötorget', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Peter Benno, MD, PhD', 'role': 'CONTACT', 'email': 'Peter.Benno@endoskopienheten.se', 'phone': '+46 705795554'}, {'name': 'Per Hellström, MD, PhD', 'role': 'CONTACT', 'email': 'Per.Hellstrom@medsci.uu.se', 'phone': '+46 70 3727423'}], 'overallOfficials': [{'name': 'Per Hellström, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uppsala University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Per Hellström', 'investigatorAffiliation': 'Uppsala University'}}}}