Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-18 @ 12:48 PM
Study NCT ID:
NCT05076656
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epigenetic and Microbiota Modifications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in HOMA-IR', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)'}], 'secondaryOutcomes': [{'measure': 'Changes in gut microbiota', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change from baseline in 16S rRNA amplicons after 3 months'}, {'measure': 'Changes in glucose metabolism', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change from baseline in oral glucose tolerance test (OGTT)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes type2', 'FMT', 'Probiotics', 'Microbiota'], 'conditions': ['Diabetes type2', 'Obesity']}, 'descriptionModule': {'briefSummary': 'In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type2 diabetes in treatment with metformin\n* 30 kg/m2≤IMC≤40 kg/m2\n* 30-70 years old\n* HOMA-IR \\>6\n* Informed consent\n\nExclusion Criteria:\n\n* psychopathologic alterations that do not permit the adherence to the trial.\n* Diabetes medication different from metformin.\n* History of cholecystectomy.\n* Use of Probiotics, and/or antibiotics in the last 3 months'}, 'identificationModule': {'nctId': 'NCT05076656', 'acronym': 'EPI-MICROBIO', 'briefTitle': 'Epigenetic and Microbiota Modifications', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud'}, 'officialTitle': 'Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction', 'orgStudyIdInfo': {'id': 'EPIGEN-MICROBIOTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics arm', 'description': 'Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)', 'interventionNames': ['Dietary Supplement: Lactobacillus fermentum D3']}, {'type': 'EXPERIMENTAL', 'label': 'FMT arm', 'description': 'Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.', 'interventionNames': ['Biological: Fecal microbiota transplant (FMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'Individuals who receive a probiotics pill daily of placebo (milk powder)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lactobacillus fermentum D3', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['PCT/EP 2012058214'], 'description': 'Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.', 'armGroupLabels': ['Probiotics arm']}, {'name': 'Fecal microbiota transplant (FMT)', 'type': 'BIOLOGICAL', 'description': 'Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.', 'armGroupLabels': ['FMT arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo in a white, gelatin capsule (orally), with powder milk', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Francisco J Tinahones, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Investigacion Biomedica de Malaga'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}