Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-28 @ 4:10 PM
Study NCT ID:
NCT01630668
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2012-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-25', 'studyFirstSubmitDate': '2012-06-26', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be the change in serum LDL-cholesterol from baseline to endpoint between control and treatment groups.', 'timeFrame': 'Week 0 and Week 12 of intervention period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Background: In recent years, probiotics have shown promise in treating a variety of diseases. Previously, the investigators have reported on the clinical efficacy of Lactobacillus reuteri NCIMB 30242 in improving the lipid profile in hypercholesterolemic adults.\n\nObjective: The purpose of the study is to determine the lipid lowering efficacy of a One-a-Day probiotic supplement capsule containing Lactobacillus reuteri NCIMB 30242 over 12 weeks in subjects with hypercholesterolemia.\n\nDesign: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. The study will last a total of 14 weeks, including a 2-week run-in period and a 12-week intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Males and females, aged 20 to 75 years (bounds included).\n* LDL-C ≥ 3.40 mmol/L (\\<15% variation between visits V0 and V2-1).\n* TG \\< 4.00 mmol/L (confirmed at visits V0 and V2-1).\n* BMI range will be 23.0 to 32.5 kg/m2 (bounds included).\n* Subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to NCEP-ATP III guidelines).\n* Judged by the investigators as compliant (\\>80%) with product consumption (check at V2-1), and motivated.\n* Signed informed consent form prior to inclusion in the study.\n* Note: Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.\n* If female, subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \\> 1 year since last menstruation). OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:\n\n * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)\n * Intrauterine devices\n * Vasectomy of partner\n * Total abstinence\n\nExclusion criteria:\n\n* Use of cholesterol lowering prescription drugs within the last 6 months.\n* Use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription supplements within last 1 month.\n* History of chronic use of alcohol (\\> 2 drinks/d).\n* History of heavy smoking (≥ 20 cigarettes/d).\n* Use of systemic antibodies, corticosteroids, androgens, or phenytoin.\n* Immune-compromised subjects (e.g. AIDS, lymphoma, subjects undergoing long-term corticosteroid treatment)\n* Subject having experienced any cardiovascular event (Myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months.\n* Subjects with elevated LDL-C (≥ 3.40 mmol/L) and high (\\>20%) CVD risk estimated by the Framingham risk score.\n* Previously diagnosed Type I or Type II diabetes.\n* Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.\n* Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.\n* History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).\n* Clinically significant abnormal laboratory results at screening.\n* Chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives.\n* History of eating disorders.\n* Exercise greater than 15 miles/wk or 4,000 kcal/wk.\n* For female subjects: Pregnancy, breast feeding, or intent to get pregnant.\n* Allergy or sensitivity to test product ingredients\n* Allergy or sensitivity to all 3 antibiotics (Clindamycin, Erythromycin and Ampicillin).'}, 'identificationModule': {'nctId': 'NCT01630668', 'briefTitle': 'Efficacy of a One-a-Day L. Reuteri NCIMB 30242 Probiotic Supplement Capsule', 'organization': {'class': 'INDUSTRY', 'fullName': 'Micropharma Limited'}, 'orgStudyIdInfo': {'id': 'MP-12LCHM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One-a-Day L. reuteri NCIMB 30242 supplement capsule', 'interventionNames': ['Dietary Supplement: One-a-Day L. reuteri NCIMB 30242 supplement capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'One-a-Day placebo capsule', 'interventionNames': ['Dietary Supplement: One-a-Day placebo capsule']}], 'interventions': [{'name': 'One-a-Day L. reuteri NCIMB 30242 supplement capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once per day, 12 weeks', 'armGroupLabels': ['One-a-Day L. reuteri NCIMB 30242 supplement capsule']}, {'name': 'One-a-Day placebo capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Once per day, 12 weeks', 'armGroupLabels': ['One-a-Day placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5R8', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KGK Synergize Inc.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Micropharma Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}