Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT05164861
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2021-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007444', 'term': 'Inulin'}, {'id': 'D014815', 'term': 'Vitamins'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005630', 'term': 'Fructans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2021-12-04', 'studyFirstSubmitQcDate': '2021-12-18', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of number bowel movements', 'timeFrame': 'two weeks', 'description': 'Number of bowel movements per week will be assessed per patients self report'}, {'measure': 'Change of stool type', 'timeFrame': 'a week', 'description': 'Stool type assessed per the Bristol stool scale (from type 1 to type 7; where type 1 - separate hard lumps, like nuts, type 7 - watery, no solid pieces, entirely liquid stool - diarrhoea)'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'two weeks', 'description': 'Number of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['specialized food product', 'kombucha', 'safety', 'efficacy', 'constipation', 'functional food'], 'conditions': ['Irritable Bowel Syndrome With Constipation', 'Constipation-predominant Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '38149073', 'type': 'DERIVED', 'citation': 'Isakov VA, Pilipenko VI, Vlasova AV, Kochetkova AA. Evaluation of the Efficacy of Kombucha-Based Drink Enriched with Inulin and Vitamins for the Management of Constipation-Predominant Irritable Bowel Syndrome in Females: A Randomized Pilot Study. Curr Dev Nutr. 2023 Nov 24;7(12):102037. doi: 10.1016/j.cdnut.2023.102037. eCollection 2023 Dec.'}, {'pmid': '36394933', 'type': 'DERIVED', 'citation': 'Pilipenko VI, Isakov VA, Morozov SV, Vlasova AV, Kochetkova AA. [Efficacy of newly developed kombucha-based specialized food product for treatment of constipation-predominant irritable bowel syndrome]. Vopr Pitan. 2022;91(5):95-104. doi: 10.33029/0042-8833-2022-91-5-95-104. Epub 2022 Aug 30. Russian.'}], 'seeAlsoLinks': [{'url': 'https://theromefoundation.org/rome-iv/rome-iv-criteria/', 'label': 'Rome IV criteria'}]}, 'descriptionModule': {'briefSummary': 'Single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations', 'detailedDescription': 'This single-center open-label non-randomized study is planned to proof the concept on safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with irritable bowel syndrome with constipations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willingness to participate (based on signed informed consent form)\n* irritable bowel syndrome with predominant constipation, per Rome IV criteria (Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool - Bristol stool scale types 1 or 2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis),\n\nExclusion Criteria:\n\n* pregnant or breast-feeding women;\n* intolerance of kombucha or any component of the product;\n* history of abdominal surgery;\n* the use of concomitant medications able to affect bowel motility;\n* general condition of a patient making the appropriateness of his participation in the study questionable;\n* chronic decompensated disorders of any organs and systems;\n* mean daily caloric intake less than 800 kcal and more than 6000 kcal\n* inability to follow standard iso-caloric diet and standard volume of water consumption (1.5-2 litres a day)'}, 'identificationModule': {'nctId': 'NCT05164861', 'acronym': 'Kombucha', 'briefTitle': 'Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations', 'organization': {'class': 'OTHER', 'fullName': 'Russian Academy of Medical Sciences'}, 'officialTitle': 'Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations', 'orgStudyIdInfo': {'id': '19-76-30014/2021K-OGIG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention/kombucha-based beverage', 'description': 'Subjects randomized to this group will receive newly developed food product - non-alcoholic pasteurized beverage based on kombucha enriched with inulin and vitamins, flavoured as "Black currant with juniper" or "Strawberries with lime" or \'Mango with passion fruit"', 'interventionNames': ['Dietary Supplement: kombucha-based beverage']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects of this group will receive standard diet with similar quantity of water as in experimental group'}], 'interventions': [{'name': 'kombucha-based beverage', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Kombucha enriched with inulin, vitamins and flavours'], 'description': "kombucha-based beverage: drinking water, black tea, kombucha, inulin, vitamins (B1, B2, B6, niacin, folic acid). Nutritional value in 100 ml: carbohydrates - 2.57 g (including sucrose - 0.22 g, glucose - 1.32 g, fructose - 1.03 g), inulin - 1.15 g (46%\\*), vitamin B1 - 0.4 mg (29%\\*), B2 - 0.21 mg (13%\\*), B6 - 0.48 mg (24%\\*), niacin - 2.74 mg (15%\\*), folic acid - 24.0 mcg (12%\\*). Energy value/Caloric content - 54 kilojoules/13 kcal (\\* - % of the recommended daily allowance, according to the Technical regulations of the Customs Union #022/2011). Flavours, identical by nutrient's content and nutrients density: black currant berries \\& juniper berries, or strawberries \\& lime leaves, or passion fruit \\& mango.\n\nPortion's volume - 220 ml. Daily intake: 1 portion", 'armGroupLabels': ['Intervention/kombucha-based beverage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115446', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Gastroenterology and Hepatology, FRC Nutrition and Biotechnology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Vasily Isakov, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal Research Center of Nutrition and Biotechnology'}]}, 'ipdSharingStatementModule': {'url': 'https://grant.rscf.ru/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'study data will available during 5 years after study completion', 'ipdSharing': 'YES', 'description': 'Blinded to personal data individual participant data may be shared per reasonable request after study completion', 'accessCriteria': 'per reasonable request to principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vasily Isakov', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azbuka vkusa', 'class': 'UNKNOWN'}, {'name': 'Russian Science Foundation', 'class': 'OTHER'}, {'name': 'Federal Research Centre of Nutrition, Biotechnology and Food Safety', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD, AGAF', 'investigatorFullName': 'Vasily Isakov', 'investigatorAffiliation': 'Russian Academy of Medical Sciences'}}}}