Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-27 @ 9:45 AM
Study NCT ID:
NCT07206303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean seated clinic systolic blood pressure (SBP)', 'timeFrame': 'During clinical visits at: - Baseline (a week prior to treatment), - Week 5 of treatment - Week 10 of treatment (end of treatment)', 'description': 'Three consecutive BP measurements will be assessed using an automatic BP monitor, Microlife BP A200 AFIB (Microlife, Taiwan). Prior to taking BP measurements, participants will be instructed to sit and rest for at least five minutes. Participants will be advised to maintain an upright posture, with their arms positioned at heart level and palms facing upwards. Additionally, they will be advised to refrain from speaking during process. The average of three BP measurements will be taken to minimize random error.'}], 'secondaryOutcomes': [{'measure': 'Mean seated clinic diastolic blood pressure (DBP)', 'timeFrame': 'During clinical visits at: - Baseline (a week prior to treatment), - Week 5 of treatment - Week 10 of treatment (end of treatment)', 'description': 'Three consecutive BP measurements will be assessed using an automatic BP monitor, Microlife BP A200 AFIB (Microlife, Taiwan). Prior to taking BP measurements, participants will be instructed to sit and rest for at least five minutes. Participants will be advised to maintain an upright posture, with their arms positioned at heart level and palms facing upwards. Additionally, they will be advised to refrain from speaking during process. The average of three BP measurements will be taken to minimize random error.'}, {'measure': 'Mean 24-hour ambulatory SBP', 'timeFrame': 'During clinical visits at: - Baseline (a week prior to treatment), - Week 10 of treatment (end of treatment)', 'description': 'A calibrated ambulatory BP monitoring device, TM-2441 (A\\&D Medical, Japan) will be fitted onto the participants, with the BP cuff placed on their non-dominant arm to record the 24-hour ambulatory BP. The BP will be measured every 30 minutes from 6 am to 10 pm and then every 60 minutes from 10 pm to 6 am.'}, {'measure': 'Gut microbiome composition and functions', 'timeFrame': 'During clinical visits at: - Baseline (a week prior to treatment), - Week 10 of treatment (end of treatment)', 'description': "Stool GM sequencing will be performed to compare GM abundance before and after probiotics intervention. This will enable metagenomic assembly community profiling and functional profiling, while facilitating the identification of presented taxa, their abundance, biochemical potential, and other relevant information. Other GM species that may be associated with hypertension could also be identified and provide valuable insights for the development of future GM-based intervention strategies. A set of OMNIgene-OMR205 kits (DNA Genotek, Canada) will be utilized for the collection and stabilization of gut microbial DNA and RNA, facilitating the profiling of gut microbiomes. We will also inquire about the participants' bowel habit concurrently, utilizing the Bristol Stool Chart as reference."}, {'measure': 'Plasma levels of gut microbiome-derived metabolites, short-chain fatty acids (SCFA) and gamma amino butyric acids (GABA)', 'timeFrame': 'During clinical visits at: - Baseline (a week prior to treatment), - Week 10 of treatment (end of treatment)', 'description': 'The level of SCFAs in blood sample will be detected by a two-steps analysis: the blood sample will be first derivatized by 1-propanol/pyridine (3:2, v: v) and propyl chloroformate followed by the quantification using 7890B gas chromatography-mass spectrometry after centrifugation of blood.'}, {'measure': 'Serum levels of proinflammatory and oxidative stress markers', 'timeFrame': 'During clinical visits at: - Baseline (a week prior to treatment), - Week 10 of treatment (end of treatment)', 'description': 'Various inflammatory markers, including IL-1, IL-6, IL-8, TNF-α, IL-10 will be assessed using LEGENDplex™ 13-plex pro-inflammatory cytokine panel (BioLegend Inc., USA). Damages caused by radicals or excessive oxidants will be measured in the blood. DNA/RNA damage will be assessed by 8-Hydroxygaunaosine (8-OHG) or detecting the general DNA damage via comet assay. Lipid damage will be assessed by measuring malondialdehyde (MDA) levels and protein modification will be assessed by measuring the levels of advanced glycation end products (AGE).\n\nA portion of every blood sample will also be collected and preserved in a PAXgene Blood RNA tube manufactured by QIAGEN in Germany. This tube enables the extraction and purification of intracellular RNA for subsequent molecular diagnostic testing.'}, {'measure': 'Sex differences in BP reduction after the intervention', 'timeFrame': 'Demographics to be collected during baseline visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'Bifidobacterium', 'probiotics'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '26690980', 'type': 'BACKGROUND', 'citation': 'Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21.'}, {'pmid': '31541197', 'type': 'BACKGROUND', 'citation': 'Kolodziejczyk AA, Zheng D, Elinav E. Diet-microbiota interactions and personalized nutrition. Nat Rev Microbiol. 2019 Dec;17(12):742-753. doi: 10.1038/s41579-019-0256-8. Epub 2019 Sep 20.'}, {'pmid': '35892633', 'type': 'BACKGROUND', 'citation': 'Azzi A. Oxidative Stress: What Is It? Can It Be Measured? Where Is It Located? Can It Be Good or Bad? Can It Be Prevented? Can It Be Cured? Antioxidants (Basel). 2022 Jul 23;11(8):1431. doi: 10.3390/antiox11081431.'}, {'pmid': '19483370', 'type': 'BACKGROUND', 'citation': 'Okita Y, Nakamura H, Kouda K, Takahashi I, Takaoka T, Kimura M, Sugiura T. Effects of vegetable containing gamma-aminobutyric acid on the cardiac autonomic nervous system in healthy young people. J Physiol Anthropol. 2009;28(3):101-7. doi: 10.2114/jpa2.28.101.'}, {'pmid': '11906718', 'type': 'BACKGROUND', 'citation': 'Hayakawa K, Kimura M, Kamata K. Mechanism underlying gamma-aminobutyric acid-induced antihypertensive effect in spontaneously hypertensive rats. 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Patient Prefer Adherence. 2022 Oct 7;16:2749-2757. doi: 10.2147/PPA.S368784. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to investigate if a Bifidobacterium-based probiotic intervention would reduce clinic systolic BP in untreated middle-aged Chinese men and women with hypertension according to ACC/AHA guidelines (SBP ≥130 mm Hg) after 10 weeks of treatment. The investigators anticipate that this feasibility study will provide rationale to conduct a larger randomized clinical trial and preliminary data to estimate the power/ sample size of a larger RCT.', 'detailedDescription': 'The primary objective of this study is to investigate if a Bifidobacterium-based probiotic intervention would reduce clinic systolic BP in untreated middle-aged Chinese men and women with hypertension according to ACC/AHA guidelines (SBP ≥130 mm Hg) after 10 weeks of treatment. The investigators anticipate that this feasibility study will provide rationale to conduct a larger randomized clinical trial and preliminary data to estimate the power/ sample size of a larger RCT.\n\nThe four independent but interrelated objectives of this study include:\n\n1. To investigate if oral administration of Bifidobacterium-based probiotic intervention will reduce clinic SBP and DBP from baseline to the end of treatment.\n2. To observe changes in 24-hour mean, daytime and nighttime SBP and DBP assessed by 24-hour ambulatory BP monitoring from baseline to the end of treatment.\n3. To evaluate the impact of probiotics intervention on gut microbiome (GM) composition and functions characterized by shotgun metagenomic sequencing of stool.\n4. To explore potential underlying mechanisms of Bifidobacterium-based probiotics on lowering BP by assessing serum proinflammatory and oxidative stress markers and circulating GM-derived metabolites, including SCFAs and GABA.\n\nAdditionally, the investigators will conduct sex-stratified analysis to explore potential sex differences in BP lowering response to the intervention since sex-linked differences in the initiation and progression of hypertension pathology are well-established, and the investigators recently reported that association between GM and hypertension is also sex-linked.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women, aged 40-65 years old.\n* Chinese residing in Hong Kong.\n* Clinic SBP ≥130mmHg according to screening measurement at baseline.\n* Untreated or not on antihypertensive medications within 4 weeks.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Clinic SBP \\>165mmHg according to screening measurement at baseline\n* Known history of diabetes, coronary artery disease, stroke, peripheral artery disease, malignancy or chronic kidney disease\n* Known history of gastrointestinal disorders including inflammatory bowel disease, irritable bowel syndrome, Helicobacter pylori infection, liver cirrhosis or long-term use of proton pump inhibitors.\n* Known increased risk of infection due to endovascular or rheumatic heart disease, endovascular grafts, congenital heart defects, endocarditis, mechanical heart valves, and permanent endovascular devices including permanent (not temporary) hemodialysis catheters, pacemakers, or defibrillators.\n* Known secondary causes of hypertension.\n* Currently taking omega-3 fatty acid supplements, probiotics, antibiotics, rifaximin, steroids, and antihypertensive agents within 4 weeks.\n* Currently taking anti-oxidant vitamins within 6 months.\n* Recent travel to tropical areas within 6 months.\n* Recent bariatric surgery, hepatic resection, intestinal resection/colectomy, or any surgery within 3 months before the study.\n* Identified higher susceptibility to infections caused by immunosuppression, such as a history of organ or hematopoietic stem cell (HSCs) transplant, neutropenia (ANC \\<500 cells/µl), HIV, and CD4 \\<200 cells/µl.\n* Known allergies to any components of commercially-available probiotic supplements.\n* Women who are pregnant, or intending to become pregnant, or lactation.\n* Intending to participate or have participated in a clinical or nutritional intervention study in the last 30 days before study enrolment.'}, 'identificationModule': {'nctId': 'NCT07206303', 'briefTitle': 'The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'The Effects of Bifidobacterium-based Probiotics in Reducing Blood Pressure in Middle-aged Chinese With Hypertension: a Single-term Feasibility Pilot Study', 'orgStudyIdInfo': {'id': 'GL202401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '30 recruited participants receiving commercially available probiotics supplements', 'description': '30 community-dwelling, middle-aged Hong Kong Chinese (15 men and 15 women) with hypertension according to ACC/AHA guidelines (SBP ≥130 mm Hg) who are not taking antihypertensive agents and are free of symptomatic cardiovascular or cerebrovascular diseases will be recruited in this study. Participants will be recruited via our outreach promotion program or social media and recruitment posters will be distributed physically or posted online.', 'interventionNames': ['Biological: Bifidobacterium probiotics supplementation']}], 'interventions': [{'name': 'Bifidobacterium probiotics supplementation', 'type': 'BIOLOGICAL', 'description': 'The 10-week research period consists of one prescreening and baseline visit (week -1) and two follow-up visits (week 5 (±7days) and week 10 (±7days)). The participants will be instructed to fast overnight before their visits in the mornings of week -1 and week 10.\n\nThe measurements will include documentation of personal and demographic information; three consecutive clinic BP readings; 24-hour ambulatory BP monitoring; a 3-day diet diary to monitor consistency of dietary intake; collection of fecal samples and blood samples for analysis of GM composition and biomarkers, respectively at baseline, and week 5 and 10.\n\nOnly participants who are able to provide all the required data and samples within 7 days after the prescreening and baseline visit (week -1) will be eligible to receive the Bifidobacterium supplementation with 20 billion cfu once a day for 10 weeks. They will be instructed to mix the probiotics with water and consume with their dinner.', 'armGroupLabels': ['30 recruited participants receiving commercially available probiotics supplements']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'contacts': [{'name': 'Gary Kui-Kai Lau', 'role': 'CONTACT', 'email': 'gkklau@hku.hk', 'phone': '+852 22554249'}, {'name': 'Joshua Wing Kei Ho', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kay Cheong Teo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hani El-Nezami', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Gary Kui-Kai Lau', 'role': 'CONTACT', 'email': 'gkklau@hku.hk', 'phone': '+852 22554249'}], 'overallOfficials': [{'name': 'Gary KK Lau', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Dr. Gary Kui Kai LAU', 'investigatorAffiliation': 'The University of Hong Kong'}}}}