Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04696718
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2020-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determination of the Biological Activity of Serum From Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'single blind'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover Assignment patient may receive 3 products in 3 interventions sequentially during the protocol'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of biological activity of serum between day 0 to day 28', 'timeFrame': 'Day 0 and Day 28', 'description': 'Ex vivo quantification of the formation of osteoclast multi-nucleated cells following culture in the presence of metabolites from the serum of patients between day 0 and day 28'}], 'secondaryOutcomes': [{'measure': 'Change of Disease Activity Score (DAS28) day 0 to day 28', 'timeFrame': 'Day 0 and Day 28', 'description': "The Disease Activity Score (DAS) is a combined index to measure the disease activity in patients with rheumatoid arthritis (RA).\n\nEvaluation of a patient's response to treatment can be made much easier and more objective using the DAS28. (Twenty-eight tender and swollen joint scores include the same joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and the knees.) Simply assess the number of swollen and tender joints and measure the ESR. The DAS will provide you with a number between 0 and 10, indicating the activity rate of the rheumatoid arthritis is at that particular moment."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'probiotics'], 'conditions': ['Women', 'Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to determine the influence of patient sera before and after probiotic intervention on the behavior of bone cells (osteoblasts and osteoclasts).\n\nThe secondary objectives are to assess the activity of bone cells and the course of rheumatoid arthritis before and after the consomption of probiotics.', 'detailedDescription': 'The written consent of the subjects will be obtained after full information of the aims, nature and possible risks of the study.\n\nBefore inclusion, subjects will undergo a medical check-up including an interview on personal and family history and drug treatments taken as well as a standard medical examination including weight, height and blood pressure measurement. . Their compliance with the inclusion / exclusion criteria will be verified during this review. An interview with personnel involved in the research (a dietician / study Research clinic assistant, etc.) will also be carried out as well as a biological selection assessment.\n\nAs part of this study, the subjects will come a total of 7 times to the Emile ROUX hospital in Le Puy en Velay.\n\nThe probiotic treatment will begin between 1 and 3 weeks after the inclusion visit. The volunteers / patients recruited will have a volume of blood sampled and a stool collected before the start of the probiotic treatment (T = 0) and at the end of the treatment (T = 4 weeks). The study consists of three periods of probiotic treatment of 4 weeks each interspersed with a wash-out period of 3 weeks in accordance with the recovery period necessary between two blood samples.\n\nThe sera thus obtained will then be analyzed to determine their biological activity with regard to the induction of changes in the behavior of bone cell models: osteoformin cells (osteoblasts) and osteo-resorbent cells (osteoclasts).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'higher prevalency of RA in women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen\n\n* 30-75 years\n* Non-menopausal or menopausal for more than 2 years because the tissue osteoarticular is under the influence of steroid hormones. Peri-menopause is accompanied by strong hormonal variations.\n* With rheumatoid arthritis (DAS28 threshold specified below)\n* Clinical arthritis score ≥ 2.6 (DAS28). Pathology needs to be characterized even if the score remains low\n* Person with good venous condition\n\nExclusion Criteria:\n\nVaccination in the last two months\n\n* Alcohol abuse with regard to WHO standards\n* Smoking (\\>5 cigarettes/day)\n\n -\\> 5 hours of intense sport per week\n* Food allergy and others\n* Antibiotic treatment in the month preceding inclusion\n* Persons under guardianship, curators, deprived of liberties, safeguard of justice\n* Refusal to sign the information and consent form'}, 'identificationModule': {'nctId': 'NCT04696718', 'acronym': 'nutricell3', 'briefTitle': 'Determination of the Biological Activity of Serum From Patients', 'organization': {'class': 'OTHER', 'fullName': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}, 'officialTitle': 'Determination of the Biological Activity of Serum From Patients With Rheumatoid Arthritis After Consumption of Three Different Probiotics Strains (Lactobacillus Salivarius, Rhamnosus, Bifidobacterium Lactis)', 'orgStudyIdInfo': {'id': '2018-A00303-52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Traitement 1', 'description': 'Lactobacillus salivarius', 'interventionNames': ['Dietary Supplement: daily supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Traitement 2', 'description': 'Lactobacillus Rhamnosus GG', 'interventionNames': ['Dietary Supplement: daily supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Traitement 3', 'description': 'Bifidobacterium lactis', 'interventionNames': ['Dietary Supplement: daily supplementation']}], 'interventions': [{'name': 'daily supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the patients will consume 1 pill of probiotic each day for 28 days per treatments each treatment is separated by a wash out period of 21 days', 'armGroupLabels': ['Traitement 1', 'Traitement 2', 'Traitement 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43000', 'city': 'Le Puy-en-Velay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'emile gadea, PhD', 'role': 'CONTACT', 'email': 'responsable.rechercheclinique@ch-lepuy.fr'}], 'facility': 'Centre Hospitalier Emile Roux', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}], 'centralContacts': [{'name': 'yohann wittrant, PhD', 'role': 'CONTACT', 'email': 'yohann.wittrant@inrae.fr', 'phone': '+33682297271'}, {'name': 'emilie gadea, PhD', 'role': 'CONTACT', 'email': 'responsable.rechercheclinique@ch-lepuy.fr'}], 'overallOfficials': [{'name': 'benjamin castagne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Emile Roux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adeline BLOT', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Emile Roux', 'class': 'OTHER'}, {'name': "Centre de Recherche en Nutrition Humaine d'Auvergne", 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Associate', 'investigatorFullName': 'Adeline BLOT', 'investigatorAffiliation': "Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement"}}}}