Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT07258732
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Probiotics on Bariatric Treatment Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-11-28', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the impact of probiotics on the resolution of constipation after sleeve gastrectomy', 'timeFrame': 'one and three months after surgery', 'description': 'The primary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked whether constipation occurred (yes or no).'}], 'secondaryOutcomes': [{'measure': 'Assessment of the impact of probiotics on gastrointestinal symptoms after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked about the number of stools passing per week.'}, {'measure': 'Assessment of the impact of probiotics on gastrointestinal symptoms after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked about the subjective assessment of the ease of defecation.\n\nA Likert scale of 1-5 was used, where 1 indicated great difficulty with defecation, and 5 indicated no difficulty with defecation.'}, {'measure': 'Assessment of the impact of probiotics on gastrointestinal symptoms after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary outcome of the study is to assess the effect of probiotics on the frequency of defecation in the early weeks following surgery. The patient would be asked about the feeling of bowel movement completeness.\n\nA Likert scale of 1-5 was used, where 1 indicated a complete feeling of incomplete defecation, and 5 indicated a complete feeling of defecation.'}, {'measure': 'Metabolic changes after the probiotics use in patients after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use.\n\nIt would be: Hemoglobin (Hb): g/dL'}, {'measure': 'Metabolic changes after the probiotics use in patients after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use.\n\nIt would be: Creatinine: mg/dL'}, {'measure': 'Metabolic changes after the probiotics use in patients after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use.\n\nIt would be: Total Protein: g/L'}, {'measure': 'Metabolic changes after the probiotics use in patients after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use.\n\nIt would be: Total Cholesterol: mg/dL'}, {'measure': 'Metabolic changes after the probiotics use in patients after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use.\n\nIt would be: HbA1c: %'}, {'measure': 'Metabolic changes after the probiotics use in patients after SG', 'timeFrame': 'one and three months after surgery', 'description': 'The secondary aim is to evaluate laboratory tests to identify any metabolic changes associated with probiotic use.\n\nIt would be: Ferritin: µg/L (ng/mL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'sleeve gastrectomy', 'constipation'], 'conditions': ['Obesity &Amp; Overweight']}, 'descriptionModule': {'briefSummary': 'The planned study aims to assess whether probiotics improve the quality of life in patients during the early postoperative period following sleeve gastrectomy, and whether they influence the absorption of micro- and macronutrients.\n\nPatients eligible for inclusion will have a BMI of 40 kg/m² or higher and must have successfully completed the qualification process for sleeve gastrectomy. Exclusion criteria include chronic gastrointestinal diseases, antibiotic use within 4 weeks prior to surgery, and lack of consent to participate in the study.\n\nOn the day before surgery, a stool sample will be collected from each patient for microbiological analysis to assess the composition of gut bacteria. Patients will then undergo sleeve gastrectomy using a standard surgical technique.\n\nAfter the operation, participants will be randomized into two groups. The first group will receive probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14. These strains are deposited in the Polish Collection of Microorganisms at the Polish Academy of Sciences in Wrocław and are protected by Polish, European, and U.S. patents. The second group will receive a placebo.\n\nAs part of follow-up, stool samples will be collected again one month and three months after surgery for comparative microbiological analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age over 18 years.\n2. BMI over 40 kg/m² or over 35 kg/m² with obesity-related comorbidities.\n3. Successful qualification for sleeve gastrectomy.\n4. Informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Age under 18 years.\n2. Chronic gastrointestinal diseases.\n3. Use of antibiotic therapy within 4 weeks prior to surgery.\n4. Lack of consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07258732', 'acronym': 'PROBE', 'briefTitle': 'The Impact of Probiotics on Bariatric Treatment Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Warmia and Mazury in Olsztyn'}, 'officialTitle': 'Study on the Impact of Probiotics on Postoperative Gastrointestinal Symptoms and Gut Microbiota After Sleeve Gastrectomy: A Randomized-Control Trial', 'orgStudyIdInfo': {'id': '1/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Dietary Supplement: Probiotic']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotics containing Bifidobacterium animalis AMT30, Bifidobacterium breve AMT32, and Lactobacillus plantarum AMT14.', 'armGroupLabels': ['Control']}, {'name': 'Diet', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10-015', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'University of Warmia and Mazury', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Warmia and Mazury in Olsztyn', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Natalia Dowgiałło-Gornowicz, MD, PhD', 'investigatorAffiliation': 'University of Warmia and Mazury in Olsztyn'}}}}