Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT06997133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sucralose as a Way to Enhance Regulatory T Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C026285', 'term': 'trichlorosucrose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regulatory T cells', 'timeFrame': 'After 4 weeks on sucralose and placebo.', 'description': 'Change in % regulatory T cells on total CD4+ T cells compared to baseline'}], 'secondaryOutcomes': [{'measure': 'T cell cytokine production (TNFa, IFNy, IL2)', 'timeFrame': '4 weeks compared to baseline on either placebo or sucralose', 'description': '% cytokine production o CD4+ and CD8+ T cells'}, {'measure': 'Frequency of immune populations in the blood (CD4+, CD8+, NK, B cells, CD11b myeloid cells)', 'timeFrame': '4 weeks compared to baseline on either sucralose or placebo', 'description': '% of CD45+ cells (total immune marker)'}, {'measure': 'Frequency of CD4+ T cells lineages', 'timeFrame': '4 weeks compared to baseline on sucralose or placebo', 'description': '% RORyt, T-bet, GATA3 on CD4+ T cells'}, {'measure': 'Frequency of naive, central and effector memory or terminally differentiated CD4+ and CD8+ T cells', 'timeFrame': '4 weeks compared to baseline on both sucralose or placebo', 'description': '% of CD62L+CD45RA+CD45RO- (naive), CD62L+CD45RO+CD44+CD45RA- (central memory), CD62L-CD45RA-CD45RO+CD44+ (effector memory) and CD62L-CD45RA+CD45RO (terminally differentiated cells) on both CD4+ and CD8+ T cells'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sucralose', 'immune system', 'regulatory T cells', 'metabolomic'], 'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': "Title: Taking the SWEET approach to protect the transplanted kidney.\n\nBackground: Kidneys are essential organs in our body. When they do not work, patients require machines to help them or receive a new kidney from a donor (transplantation) to survive. Thus far, transplantation is the best treatment. However, the immune system will recognize the new kidney as foreign and try to destroy it, which is called kidney rejection. To prevent rejection, patients with kidney transplants depend on drugs to suppress the immune system. However, these drugs have many side effects, including the risk of infection, cancer, and diabetes.\n\nThe immune system is made of many different types of cells. One cell type in particular is T cells that, when kept unchecked, will attack the kidney transplant. However, there is a small subset of these T cells called regulatory T cells (Tregs) that police the immune system and aid in accepting the new kidney. Current ways to increase these police cells (Tregs) after a transplant are expensive and not widely available. Therefore, there is a need to find a better and more accessible way to increase Treg numbers after a transplant to increase the longevity of the newly transplanted kidney.\n\nWhat we eat is critical in shaping the immune system. Artificial sweeteners, like sucralose (found in Splenda), are often used as a sugar substitute. They are low in calories and safe to consume. However, recent studies suggest they may have unexpected effects on the body. Research in mice has shown that sucralose impacts the immune system. Specifically, the investigators have found that it could suppress T cells that could cause kidney rejection while increasing the Tregs (the police).\n\nGiven these findings, the investigators hypothesize that sucralose could be beneficial in conditions where dampening the immune system is desirable, such as in the case of transplantation. By boosting Tregs and reducing the anti-transplant T cells, sucralose may help to protect against organ rejection.\n\nPurpose: The goal of this study is thus to test whether sucralose can safely and effectively modulate the immune system in humans.\n\nMethod: The investigator propose to test the impact of sucralose on the immune system. This pilot study will test the effect of sucralose in 10 healthy volunteers. The participants will take sucralose or placebo as a pill twice daily for a month. Healthy volunteers will then stop for a two weeks (washout period). After the washout period, the volunteers on sucralose will switch to placebo, while the placebo group will switch to sucralose pills for one more months. The investigators will take blood samples at the beginning, after one month, after the washout and at the end of the study to study how the immune system changes.\n\nAnticipated outcomes: The investigators expect that sucralose will impact the immune system and increase the number of regulatory T cells.\n\nRelevance to patient/community: Artificial sweeteners are commonly used in the food and pharmaceutical industries. However, their impact on the immune system has not been thoroughly investigated in humans.\n\nConclusion: Kidney transplantation is the most effective treatment for kidney failure, but the immune system's rejection of the transplanted organ remains a major challenge. Current immunosuppressive drugs used to prevent rejection have significant side effects, underscoring the need for safer alternatives. The investigator research suggests that sucralose, a widely used artificial sweetener, may offer a novel solution by increasing the good T cells (Tregs) and reducing harmful T cells that contribute to rejection. This pilot study will explore sucralose's potential to modulate the immune system in humans, potentially leading to improved transplant outcomes and broader implications for immune regulation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight comparable to average reported in Canada\n\nExclusion Criteria:\n\n* Past medical history of autoimmune disease\n* The use of any regular medication except contraceptive pills\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06997133', 'acronym': 'SWEET', 'briefTitle': 'Sucralose as a Way to Enhance Regulatory T Cells', 'organization': {'class': 'OTHER', 'fullName': "Ciusss de L'Est de l'Île de Montréal"}, 'officialTitle': 'Sucralose as a Way to Enhance Regulatory T Cells: The Sweet Trial', 'orgStudyIdInfo': {'id': '2025-3912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Starting with placebo - washout - sucralose.', 'description': 'This group will start with a placebo (4 weeks) , then will have a washout period (2 weeks) and then will test sucralose (4 weeks)', 'interventionNames': ['Dietary Supplement: sucralose', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Starting with sucralose - washout - placebo.', 'description': 'This group will start with sucralose (4 weeks) , then will have a washout period (2 weeks) and then will test the placebo (4 weeks)', 'interventionNames': ['Dietary Supplement: sucralose', 'Other: Placebo']}], 'interventions': [{'name': 'sucralose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Encapsulated sucralose po BID', 'armGroupLabels': ['Starting with placebo - washout - sucralose.', 'Starting with sucralose - washout - placebo.']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Encapsulated lactose po bid', 'armGroupLabels': ['Starting with placebo - washout - sucralose.', 'Starting with sucralose - washout - placebo.']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Caroline Lamarche, MD, MSc', 'role': 'CONTACT', 'email': 'caroline.lamarche.1@umontreal.ca', 'phone': '514-252-3400', 'phoneExt': '8682'}, {'name': 'Caroline Lamarche, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Centre de recherche de l'Hôpital Maisonneuve-Rosemont", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Caroline Lamarche, MD, MSc', 'role': 'CONTACT', 'email': 'caroline.lamarche.1@umontreal.ca', 'phone': '514-252-3400', 'phoneExt': '8682'}, {'name': 'Julianna Blagih, PhD', 'role': 'CONTACT', 'email': 'juliannablagih@gmail.com', 'phone': '514-252-3400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Caroline Lamarche', 'class': 'OTHER'}, 'collaborators': [{'name': "Ciusss de L'Est de l'Île de Montréal", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, clinical assistant professor', 'investigatorFullName': 'Caroline Lamarche', 'investigatorAffiliation': "Ciusss de L'Est de l'Île de Montréal"}}}}