Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-01-06 @ 7:17 PM
Study NCT ID:
NCT01102894
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2010-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study Using a Wireless Motility Capsule
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005518', 'term': 'Food Preferences'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jslavin@umn.edu', 'phone': '612-624-7234', 'title': 'Dr. Joanne Slavin', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "The study interventions were not randomized, which doesn't allow for period effect calculations. The SmartPill can reside in the stomach for longer than a few hours, which can skew results."}}, 'adverseEventsModule': {'timeFrame': 'Study length', 'description': 'No Adverse events were recorded during the study', 'eventGroups': [{'id': 'EG000', 'title': 'High Fiber', 'description': 'Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Fiber', 'description': 'Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Whole Gut Transit Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Fiber', 'description': 'Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill'}, {'id': 'OG001', 'title': 'Low Fiber', 'description': 'Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants had their transit time assessed.'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Tolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Fiber', 'description': 'Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill'}, {'id': 'OG001', 'title': 'Low Fiber', 'description': 'Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 4', 'description': 'Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant completed a gastrointestinal tolerance questionnaire during each treatment period.'}, {'type': 'SECONDARY', 'title': 'Food Intake Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Fiber', 'description': 'Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill'}, {'id': 'OG001', 'title': 'Low Fiber', 'description': 'Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '15', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Total dietary fiber consumed.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Day 1 of each treatment subjects completed a 24 hour food record to determine baseline dietary fiber intake'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Fiber and Low Fiber', 'description': 'Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time\n\nSmartPill : SmartPill'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the University of Minnesota via fliers on the St. Paul campus', 'preAssignmentDetails': 'Exclusion criteria included contraindicated conditions for the SmartPill: dysphasia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, previous gastrointestinal surgery, implanted electro-mechanical medical devices, and medications shown to influence gastrointestinal transit time.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Fiber and High Fiber', 'description': 'Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber\n\nSmartPill : SmartPill'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2010-03-24', 'resultsFirstSubmitDate': '2013-02-07', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-15', 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole Gut Transit Time', 'timeFrame': '5 days', 'description': 'The time required for the SmartPill to travel through the entire gastrointestinal tract and be present in the feces.'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal Tolerance', 'timeFrame': 'Day 4', 'description': 'Subjects scored their gastrointestinal tolerance based on 7 questions on a 0-10 scale on day 4 of each treatment period and the sum score was reported. 0 being the best and 10 being the worst. Each question has a value of 1-10 for a total of 70 points as value.'}, {'measure': 'Food Intake Diary', 'timeFrame': 'Day 1', 'description': 'Total dietary fiber consumed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Food Selection']}, 'referencesModule': {'references': [{'pmid': '21138605', 'type': 'DERIVED', 'citation': 'Timm D, Willis H, Thomas W, Sanders L, Boileau T, Slavin J. The use of a wireless motility device (SmartPill(R)) for the measurement of gastrointestinal transit time after a dietary fibre intervention. Br J Nutr. 2011 May;105(9):1337-42. doi: 10.1017/S0007114510004988. Epub 2010 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'Research suggests dietary fiber may decrease transit time through the gastrointestinal tract. Research studies traditionally use radio-opaque markers to determine gastric emptying, colonic transit, and whole gut transit time. The SmartPill is a single use pill that can be used to determine gastric emptying, colonic transit, and whole gut transit time without requiring X-rays or fecal collections. Previous studies have found radio-opaque markers and the SmartPill detect the similar transit times.\n\nThe purpose of this pilot study is to determine if the SmartPill can detect a change in transit time using a significant dose of dietary fiber.', 'detailedDescription': 'The ability of a device to track gastrointestinal transit time, including gastric emptying time, was measured in healthy people consuming low and high fiber diets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* Age 18 - 65\n* Non-smoking\n* Not taking medication\n* Non-dieting\n* BMI 18-30\n* English literacy\n* Ability to swallow the SmartPill\n\nExclusion Criteria:\n\n* Do not regularly consume breakfast\n* Food allergies to ingredients fond in study products\n* Dislike of hot cereal\n* BMI \\<18 or \\>30\n* Are not weight stable\n* Diagnosed with diabetes, cardiovascular, renal, or hepatic disease\n* Cancer in previous 5 years (except basal cell carinoma of the skin)\n* Any gastrointestinal disease or condition\n* Any gastrointestinal surgeries that alter motility\n* Recent antibiotic usage (\\< 6 months)\n* recent or concurrent participation in an intervention research study\n* History of drug or alcohol abuse in prior 6 months\n* Use of laxatives, anti-diarrheal, antacids, or medications which alter motility\n* Vegetarians\n* People who eat more than approximately 15 grams of fiber per day\n* Currently consume fiber supplements\n* Women who are pregnant or lactating\n* Women with irregular menstrual cycles'}, 'identificationModule': {'nctId': 'NCT01102894', 'briefTitle': 'Pilot Study Using a Wireless Motility Capsule', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Measurement of Whole Gut Transit Time After a Dietary Fiber Treatment Using a Wireless Motility Capsule', 'orgStudyIdInfo': {'id': '0903M60781'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low fiber and High Fiber', 'description': 'Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time', 'interventionNames': ['Device: SmartPill']}], 'interventions': [{'name': 'SmartPill', 'type': 'DEVICE', 'description': 'SmartPill', 'armGroupLabels': ['Low fiber and High Fiber']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55108', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota - McNeal Hall', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Joanne L Slavin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Mills', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}