Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-31 @ 10:08 PM
Study NCT ID:
NCT06619067
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2024-09-27', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maintenance and/or improvement of intestinal health and health-related quality of life (through the GIQLI questionnaire)', 'timeFrame': 'Baseline, After 3 months of intervention, at follow-up (one month after the end of administration'}], 'secondaryOutcomes': [{'measure': 'Intestinal microbiota composition', 'timeFrame': 'Baseline, After 3 months of intervention, at follow-up (one month after the end of administration', 'description': 'Metagenomic analysis on faecal samples'}, {'measure': 'SCFA determination', 'timeFrame': 'Baseline, After 3 months of intervention, at follow-up (one month after the end of administration', 'description': 'Gas chromatographic analysis of fecal water'}, {'measure': 'Changes in quality of life.', 'timeFrame': 'Baseline, After 3 months of intervention, at follow-up (one month after the end of administration', 'description': 'Assessed by PGWBI (The Psychological General Well-Being Index)'}, {'measure': 'Changes in intestinal functionality', 'timeFrame': 'Baseline, After 3 months of intervention, at follow-up (one month after the end of administration', 'description': 'Assessed in accordance with the Bristol Stool Form Scale'}, {'measure': 'Changes on gastrointestinal symptoms', 'timeFrame': 'Baseline, After 3 months of intervention, at follow-up (one month after the end of administration', 'description': 'Assessed by the GSRS (Gastrointestinal Symptom Rating Scale)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Gut health', 'Microbiota'], 'conditions': ['Gut', 'Microbiota Balance']}, 'referencesModule': {'references': [{'pmid': '9481153', 'type': 'BACKGROUND', 'citation': 'Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75-83. doi: 10.1023/a:1008841022998.'}, {'pmid': '9299672', 'type': 'BACKGROUND', 'citation': 'Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.'}, {'pmid': '7749697', 'type': 'BACKGROUND', 'citation': 'Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.'}, {'pmid': '27500859', 'type': 'BACKGROUND', 'citation': 'Sanchez B, Delgado S, Blanco-Miguez A, Lourenco A, Gueimonde M, Margolles A. Probiotics, gut microbiota, and their influence on host health and disease. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600240. Epub 2016 Oct 10.'}, {'pmid': '19519443', 'type': 'BACKGROUND', 'citation': 'Possemiers S, Grootaert C, Vermeiren J, Gross G, Marzorati M, Verstraete W, Van de Wiele T. The intestinal environment in health and disease - recent insights on the potential of intestinal bacteria to influence human health. Curr Pharm Des. 2009;15(18):2051-65. doi: 10.2174/138161209788489159.'}, {'pmid': '14747689', 'type': 'BACKGROUND', 'citation': 'Mai V, Morris JG Jr. Colonic bacterial flora: changing understandings in the molecular age. J Nutr. 2004 Feb;134(2):459-64. doi: 10.1093/jn/134.2.459.'}, {'pmid': '12927512', 'type': 'BACKGROUND', 'citation': 'Tuohy KM, Probert HM, Smejkal CW, Gibson GR. Using probiotics and prebiotics to improve gut health. Drug Discov Today. 2003 Aug 1;8(15):692-700. doi: 10.1016/s1359-6446(03)02746-6.'}, {'pmid': '35927504', 'type': 'BACKGROUND', 'citation': 'Sola KF, Vladimir-Knezevic S, Hrabac P, Mucalo I, Saso L, Verbanac D. The effect of multistrain probiotics on functional constipation in the elderly: a randomized controlled trial. Eur J Clin Nutr. 2022 Dec;76(12):1675-1681. doi: 10.1038/s41430-022-01189-0. Epub 2022 Aug 4.'}, {'pmid': '21899798', 'type': 'BACKGROUND', 'citation': 'Rizzardini G, Eskesen D, Calder PC, Capetti A, Jespersen L, Clerici M. Evaluation of the immune benefits of two probiotic strains Bifidobacterium animalis ssp. lactis, BB-12(R) and Lactobacillus paracasei ssp. paracasei, L. casei 431(R) in an influenza vaccination model: a randomised, double-blind, placebo-controlled study. Br J Nutr. 2012 Mar;107(6):876-84. doi: 10.1017/S000711451100420X. Epub 2011 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'It is now known that intestinal health has a strong influence on the entire body. Recent research advances have demonstrated the involvement of the intestinal microbiota in the well-being of the intestine. Preventive medicine is increasingly perceived as important in medical and economic terms, particularly in the field of gastroenterology. An innovative approach to support gut health is based on the use of modulators of the intestinal microbiome or gastrointestinal barrier, such as probiotics or prebiotics. The rationale for this study is therefore based on the hypothesis that the combination of 11 probiotic strains, conveyed through the PROBAFLOR food supplement, can play a positive role in maintaining normal intestinal function, bringing benefits to the subject who takes this supplement.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled intervention study with a duration of 3 months of intervention + 1 month of follow-up, on biological samples. Eligible participants will be randomized and receive either the probioic or placebo supplement to consume daily for 3 months. Three check-in visits will occur, one at the screening, the second one afetr the 3-months intervention and the final one after 1 month of followup. Participants will be expected to complete a daily study diary documenting their investigational product use/adverse events and a daily bowel habits diary documenting each bowel movement. Stool samples, and questionnaires will be completed for study outcome analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women aged between 18 and 65;\n* healthy based on medical history;\n* commitment to comply with all firm procedures;\n* commitment to refrain from using any home remedies to control gastrointestinal problems, particularly if live bacteria are involved;\n* signature of informed consent.\n\nExclusion Criteria:\n\n* use of probiotics continuously, in the two months prior to enrollment;\n* use of antibiotics in the month before enrollment;\n* chemotherapy treatments;\n* diagnosis of respiratory, hepatic and/or renal failure;\n* Clinically significant diseases of the gastrointestinal tract (examples include, but are not limited to, celiac disease, gluten intolerance/sensitivity, inflammatory bowel disease);\n* Women who are pregnant, breastfeeding or planning to become pregnant during the study;\n* Allergy or sensitivity to the active or inactive ingredients of the investigational product.'}, 'identificationModule': {'nctId': 'NCT06619067', 'acronym': 'PROBAFLOR', 'briefTitle': 'Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synbiotec Srl'}, 'officialTitle': 'Efficacy Study of the Probiotic Food Supplement PROBAFLOR for Maintaining Intestinal Well-being: Single-centre, Controlled, Randomized, Parallel Group, Double-blind Clinical Study', 'orgStudyIdInfo': {'id': '2024/19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treated group', 'description': 'Dietary supplement: PROBAFLOR 20 Billion CFU/dose, serving size = 1 capsule/day', 'interventionNames': ['Dietary Supplement: PROBAFLOR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo Placebo product, serving size = 1 capsule/day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'PROBAFLOR', 'type': 'DIETARY_SUPPLEMENT', 'description': 'PROBAFLOR is a food supplement made up of 11 bacterial strains and inulin. The bacterial strains present are: Bifidobacterium lactis BLC1, Lactococcus lactis LL82, Lactobacillus plantarum 14D, Lactobacillus acidophilus LA1, Streptococcus thermophilus Z57, Bifidobacterium longum SP54, Lactobacillus rhamnosus SP1, Lactobacillus bulgaricus LB2, Bifidobacterium bifidum SP9,Lactobacillus salivarius SP2, Lactobacillus casei BGP93.', 'armGroupLabels': ['Treated group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62032', 'city': 'Camerino', 'state': 'Macerata', 'country': 'Italy', 'facility': 'Scuola di Bioscienze e Medicina Veterinaria, Università di Camerino', 'geoPoint': {'lat': 43.13866, 'lon': 13.06785}}], 'overallOfficials': [{'name': 'Maria Cristina Verdenelli, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Synbiotec Srl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synbiotec Srl', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}