Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT04164394
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2019-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of I31 Probiotic on Lactose Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007787', 'term': 'Lactose Intolerance'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D005414', 'term': 'Flatulence'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Allocation is 2:1 to probiotic and placebo arms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Symptoms Score', 'timeFrame': '3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)', 'description': 'Total score of the "Symptoms Questionnaire for Lactose Malabsorption Screening" (Casellas et al. Dig Dis Sci 2009; 54:1059-65). Score ranges 0 to 50, where 50 represents maximum symptoms severity'}], 'secondaryOutcomes': [{'measure': 'Abdominal Pain subscore', 'timeFrame': '3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)', 'description': 'Abdominal pain Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum pain severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)'}, {'measure': 'Vomiting subscore', 'timeFrame': '3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)', 'description': 'Vomiting Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum vomiting severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)'}, {'measure': 'Intestinal Sounds subscore', 'timeFrame': '3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)', 'description': 'Intestinal Visual Analog Scale (VAS) sounds subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum intestinal sounds severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)'}, {'measure': 'Flatulence subscore', 'timeFrame': '3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)', 'description': 'Flatulence Visual Analog Scale (VAS) subscore of the "Symptoms Questionnaire for Lactose Malabsorption Screening". Score ranges 0 to 10, where 10 represents maximum flatulence severity (Casellas et al. Dig Dis Sci 2009; 54:1059-65)'}, {'measure': 'Lactose Hydrogen Breath Test (LHBT)', 'timeFrame': '3 hours (performed after 25 gr lactose challenge, at baseline and after 8 weeks of intervention)', 'description': 'LHBT test performed with 25 gr of lactose after an overnight fast. Measurements 10 minutes before lactose ingestion and 60, 120 and 180 minutes after lactose ingestion. CO2 (Carbon Dioxide) used as control. If more than 10ppm in the measurement before ingestion of lactose, and LHBT test was rescheduled and recommendations to avoid complex carbohydrates 24h before the test were repeated. Carbon dioxide (CO2) was measured and used to adjust breath sample for non-alveolar dilution of exhaled air.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotic', 'Diarrhea', 'Abdominal pain', 'Flatulence'], 'conditions': ['Lactose Intolerance']}, 'descriptionModule': {'briefSummary': 'This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.', 'detailedDescription': 'People with lactose intolerance are unable to fully digest the sugar (lactose) in milk. As a result, they may have diarrhea, abdominal pain, gas and bloating after eating or drinking dairy products. A deficiency of lactase - an enzyme produced in your small intestine - is usually responsible for lactose intolerance. Many people have low levels of lactase but are able to digest milk products without problems. In lactose intolerance, though, lactase deficiency leads to symptoms after eating dairy foods.\n\nI31 is a probiotic formula composed of Pediococcus acidilactici strain CECT7483 and Lactobacillus plantarum strains CECT7484 and CECT7485, previously shown to improve intestinal sensitivity in patients with Irritable Bowel Syndrome (IBS). IBS is a functional intestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits, often accompanied by bloating. Given the overlap in symptoms between IBS and lactose intolerance, it is hypothesized that I31 formula could be beneficial for individuals with lactose intolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects attending Hospital Juarez de Mexico with self-reported lactose intolerance, a minimum lactose intolerance symptom score of 6 points, 20ppm during the Lactose Hydrogen Breath Test (LHBT) and providing Informed Consent.\n\nExclusion Criteria:\n\n* More than 10 ppm before ingestion of lactose in the Lactose Hydrogen Breath Test (LHBT). If such value was observed, the LHBT test was repeated on a 2nd day, and if \\>10ppm persisted, patient was excluded.\n* BMI below 18 or above 40\n* Subjects not accepting to maintain their dietary and physical activity pattern unchanged for the duration of the study\n* Subjects with congenital lactase deficiency\n* Pregnant or lactating women\n* Significant gastrointestinal disease, such as inflammatory bowel disease, coeliac disease, chronic diarrhea or gastroparesis\n* History of gastrointestinal surgery in the 6 months prior to inclusion\n* History of intestinal perforation\n* History of acute gastroenteritis, acute gastroenteritis or hospitalization in the 4 weeks prior to inclusion\n* Substance abuse\n* Untreated thyroid disorder\n* Cancer\n* Other severe diseases that in the doctor's opinion could interfere with the study\n* Known allergy to any of the components in the treatments"}, 'identificationModule': {'nctId': 'NCT04164394', 'briefTitle': 'Effect of I31 Probiotic on Lactose Intolerance', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Juarez de Mexico'}, 'officialTitle': 'Efficacy of Probiotic I31 on Symptomatic Improvement in Patients With Lactose Intolerance', 'orgStudyIdInfo': {'id': 'HJM 0431/18-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo treatment (maltodextrin), once daily (u.i.d)', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)', 'interventionNames': ['Dietary Supplement: I31 Probiotic']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo treatment (maltodextrin), once daily (u.i.d)', 'armGroupLabels': ['Placebo']}, {'name': 'I31 Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)', 'armGroupLabels': ['Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07760', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Juarez de Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Nuria Perez Lopez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Juarez de Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Juarez de Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Digestive Physiology Lab Head', 'investigatorFullName': 'Nuria Pérez López', 'investigatorAffiliation': 'Hospital Juarez de Mexico'}}}}