Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-30 @ 9:51 PM
Study NCT ID:
NCT01825434
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2013-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-02', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-04-02', 'lastUpdatePostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colonic transit', 'timeFrame': 'Colonic transit time and Agachan score will be evaluated before and in day15 aftler yogurt ingestion. All particIpants will be followed for 30 days after the end of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic constipation', 'Lactobacillus acidophilus NCFM', 'Bifidobacterium lactis HN019'], 'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'Background and aims:Constipation is a frequent complaint and the combination of a prebiotic and probiotics would have a potentially synergic effect on the intestinal transit. The present study therefore aims to investigate the combination of polydextrose (Litesse®), L. acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who suffer from constipation.\n\nMethods: Patients with constipation were randomly divided into two groups, Placebo Group (PG) and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14 days. Those in the CG received only yogurt, while the TG received yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513). Expect that patients who took a combination of polydextrose has a decrease in the colonic transit time (CTT) when comparing initial and final transit time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chonic constipation\n* agachan between 10 and 20\n* bowel transit time with ingestion of 24 radiopaque markers (Sitzmarks) and retention of 80% of them on day 5\n\nExclusion Criteria:\n\n* Patients with hypothyroidism\n* antidepressant users\n* normal colonic\n* transit time (24 hrs or less) as well as higher than 96 hours were'}, 'identificationModule': {'nctId': 'NCT01825434', 'briefTitle': 'Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Effect of Yogurt Containing Polydextrose, Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis HN019: a Randomized, Double-blind, Controlled Study in Chronic Constipation', 'orgStudyIdInfo': {'id': 'CE 454/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group', 'description': 'yogurt containing polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513) 1 time per day, for 30 days.', 'interventionNames': ['Dietary Supplement: yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebol group', 'description': 'regular yogurt, 1 time per day for 30 days.'}], 'interventions': [{'name': 'yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['acidophilus NCFM® (ATCC 700396)', 'lactis HN019 (AGAL NM97/09513)'], 'description': 'NCFM Group', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13083-887', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Campinas', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Claudio SR Coy, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campinas, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Claudio Saddy Rodrigues Coy', 'investigatorAffiliation': 'University of Campinas, Brazil'}}}}