Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 5:27 AM
Study NCT ID:
NCT01540669
Status:
TERMINATED
Last Update Posted:
2016-01-22
First Post:
2012-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C033375', 'term': 'polydextrose'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'whyStopped': 'Slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-21', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole gut transit time', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient assessment of constipation quality of life', 'timeFrame': '2 weeks'}, {'measure': 'Patient assessment of constipation symptoms', 'timeFrame': '2 weeks'}, {'measure': 'Bowel Function Index', 'timeFrame': '2 weeks'}, {'measure': 'Adequate relief of constipation', 'timeFrame': '2 weeks'}, {'measure': 'Bowel movement frequency', 'timeFrame': '2 weeks'}, {'measure': 'Stool consistency', 'timeFrame': '2 weeks'}, {'measure': 'Degree of straining', 'timeFrame': '2 weeks'}, {'measure': 'Subjective assessment of bowel emptying', 'timeFrame': '2 weeks'}, {'measure': 'Abdominal discomfort/bloating', 'timeFrame': '2 weeks'}, {'measure': 'Overall product satisfaction', 'timeFrame': '2 weeks'}, {'measure': 'Blood and urine safety analysis', 'timeFrame': '2 weeks'}, {'measure': 'Adverse events', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['constipation', 'functional constipation', 'polydextrose', 'whole gut transit time'], 'conditions': ['Functional Constipation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.', 'detailedDescription': 'Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70 years\n* Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)\n* Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):\n\nMust meet 2 or more of the following criteria:\n\n* Straining during at least 25% of defecations\n* Lumpy or hard stools in at least 25% of defecations\n* Sensation of incomplete evacuation for at least 25% of defecations\n* Sensation of anorectal obstruction/blockage for at least 25% of defecations\n* Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)\n* Fewer than three defecations per week\n\n * Loose stools are rarely present without the use of laxatives\n * Insufficient criteria for irritable bowel syndrome\n * Ability of the participant (in the investigator\'s opinion) to comprehend the full nature and purpose of the study including possible risks and side effects\n * Consent to the study and willing to comply with study product and methods\n * Willingness to maintain a stable diet throughout the study\n * Consistent use and dose of chronic medication, if any, in the past 30 days\n\nExclusion Criteria:\n\n* Major gastrointestinal complication (e.g. Crohn"s disease, colitis, celiac disease)\n* Febrile diverticulitis within 1 year of screening\n* Pelvic floor dysfunction\n* Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results\n* Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, removal of gall bladder\n* Clinically significant underlying systemic illness that may preclude the subject"s ability to complete the trial or that may confound the study outcomes\n* Any clinically relevant abnormalities in the physical examination or in laboratory variables before entry into the study\n* Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening\n* Laxative, fiber supplement, or other constipation medication (e.g. prokinetic drugs) use within 2 weeks of screening\n* Antibiotic use within 1 month of enrollment\n* Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#- antagonists, antacids with magnesium or aluminum, or diarrhea medication)\n* Anticipated major dietary or exercise changes during the study period\n* Known allergies to any substance in the study product\n* Pregnant or lactating female, or pregnancy planned during study period\n* Eating disorder\n* History of alcohol, drug, or medication abuse\n* Participation in another study with any investigational product within 3 months of screening\n* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study'}, 'identificationModule': {'nctId': 'NCT01540669', 'acronym': 'PDX-Transit', 'briefTitle': 'Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time', 'organization': {'class': 'INDUSTRY', 'fullName': 'Danisco'}, 'officialTitle': 'Dose-ranging Efficacy of 2-week Polydextrose Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebocontrolled Trial', 'orgStudyIdInfo': {'id': 'Q-PRE-0111-CLI-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Polydextrose, low dose', 'description': 'Polydextrose, low dose', 'interventionNames': ['Dietary Supplement: Polydextrose, low dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polydextrose, medium dose', 'description': 'Polydextrose, medium dose', 'interventionNames': ['Dietary Supplement: Polydextrose, medium dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Polydextrose, high dose', 'description': 'Polydextrose, high dose', 'interventionNames': ['Dietary Supplement: Polydextrose, high dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo powder', 'description': 'Placebo powder', 'interventionNames': ['Dietary Supplement: Placebo powder']}], 'interventions': [{'name': 'Polydextrose, low dose', 'type': 'DIETARY_SUPPLEMENT', 'description': '4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks', 'armGroupLabels': ['Polydextrose, low dose']}, {'name': 'Polydextrose, medium dose', 'type': 'DIETARY_SUPPLEMENT', 'description': '8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks', 'armGroupLabels': ['Polydextrose, medium dose']}, {'name': 'Polydextrose, high dose', 'type': 'DIETARY_SUPPLEMENT', 'description': '12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks', 'armGroupLabels': ['Polydextrose, high dose']}, {'name': 'Placebo powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo powder will be mixed with beverage and consumed once per day for 2 weeks', 'armGroupLabels': ['Placebo powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Silvio Danese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Clinico Humanitas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Terminated'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danisco', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sprim Advanced Life Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}