Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-05 @ 5:01 PM
Study NCT ID:
NCT02518295
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2015-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007787', 'term': 'Lactose Intolerance'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2015-08-05', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lactose malabsorption as represented by the increase of exhaled hydrogen compared to baseline measured by the hydrogen Breath Test (HBT)', 'timeFrame': 'HBT measured every hour during 4 hours after challenge (HBT curve)'}], 'secondaryOutcomes': [{'measure': 'Assessment of improvement of lactose intolerance symptoms using a composite score equal to the sum of individual symptoms measured using a visual analog scale (VAS)', 'timeFrame': '4 hours after every milk intake, from the time of ingestion up to 5 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lactose Intolerance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains help improve lactose digestion in subjects with lactose maldigestion.', 'detailedDescription': 'The trial will be cross over, randomized in incomplete blocks, controlled, double-blind:\n\neach subject will be administered 3 products out of 4 (positive control, probiotic Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in a random order on 3 different days separated by a washout period of at least one week, and maximum 2 weeks between each challenge.\n\nThe total sample size is 42 enrolled subjects/37 completed Patients will be males and females aged between 20 and 65 years with positive hydrogen breath test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. HBT\\> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests\n2. Having signed the informed consent or having provide his/her legal representative's informed consent\n\nExclusion Criteria:\n\n1. Known Food allergy\n2. Any obstructive (COPD, asthma…) or restrictive respiratory syndrome that may impact breath test measurements\n3. Any medically relevant malabsorption syndrome\n4. Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire\n5. Ongoing therapy with drugs known to affect gut motility\n6. Any general antibiotherapy taken during or within 4 weeks of study onset\n7. Use of lactase pill (eg. Lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to Visit 0b\n8. Subject who cannot be expected to comply with the study procedures\n9. Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.\n10. To be a close collaborator to the Investigators, either in terms of Family relationship and/or professional relationship\n11. Pregnancy, based on anamnesis"}, 'identificationModule': {'nctId': 'NCT02518295', 'briefTitle': 'β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion: Probiotic and Lactose Intolerance', 'orgStudyIdInfo': {'id': '14.33. MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control', 'description': 'Ultra high temperature (UHT) milk containing 18 g total lactose', 'interventionNames': ['Other: Positive control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control with S. thermophilus', 'description': 'UHT milk containing 18 g total lactose+ S. thermophilus', 'interventionNames': ['Other: Probiotic S. thermophilus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control with B. longum', 'description': 'UHT milk containing 18 g total lactose+ B. longum', 'interventionNames': ['Other: Probiotic B. longum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Negative control', 'description': 'Lactose free milk', 'interventionNames': ['Other: Negative control']}], 'interventions': [{'name': 'Positive control', 'type': 'OTHER', 'description': '200ml milk containing 18g lactose', 'armGroupLabels': ['Positive control']}, {'name': 'Probiotic S. thermophilus', 'type': 'OTHER', 'description': '200ml milk containing 18g lactose + probiotic S. thermophilus', 'armGroupLabels': ['Positive control with S. thermophilus']}, {'name': 'Probiotic B. longum', 'type': 'OTHER', 'description': '200ml milk containing 18g lactose + probiotic B. longum', 'armGroupLabels': ['Positive control with B. longum']}, {'name': 'Negative control', 'type': 'OTHER', 'description': '200 ml of UHT Lactose free milk', 'armGroupLabels': ['Negative control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-1000', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Metabolic Unit', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Stéphane Duboux', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Société des Produits Nestlé (SPN)'}, {'name': 'Gabriela Bergonzelli, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Société des Produits Nestlé (SPN)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}