Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-02 @ 4:30 AM
Study NCT ID:
NCT01491659
Status:
WITHDRAWN
Last Update Posted:
2013-09-24
First Post:
2011-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-23', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of Antibiotic Associated Diarrhea', 'timeFrame': '17 days'}], 'secondaryOutcomes': [{'measure': 'Duration of Antibiotic Associated Diarrhoea', 'timeFrame': '17 days'}, {'measure': 'Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day', 'timeFrame': '17 days'}, {'measure': 'Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom', 'timeFrame': '17 days'}, {'measure': 'Changes in the Gut Microbiota Composition', 'timeFrame': '17 days'}, {'measure': 'Changes in Markers of Antibiotic Resistance', 'timeFrame': '17 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diarrhoea']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4141002&StudyName=A%20Study%20to%20Evaluate%20the%20Effect%20and%20Safety%20of%20Idoform%20Plus%20on%20Bowel%20Side%20Effects%20in%20Healthy%20Subjects%20Treated%20With%20Amoxicillin/%20Clavul', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers 18-70 years of age\n* Subjects with normal gastrointestinal function\n* Subjects willing to provide written informed consent\n\nExclusion Criteria:\n\n* Subjects receiving antibiotic treatment within three months prior to inclusion in the study\n* Pregnancy or planned pregnancy\n* Breast feeding\n* Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components\n* Subjects with known renal insufficiency\n* Subjects using products containing probiotics, fibers and/or prebiotics\n* Subjects using proton pump inhibitors\n* Subjects using H2 antagonists\n* Subjects using antacids frequently'}, 'identificationModule': {'nctId': 'NCT01491659', 'briefTitle': 'A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate', 'orgStudyIdInfo': {'id': 'B4141002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin/clavulanate/Idoform Plus', 'interventionNames': ['Dietary Supplement: Idoform Plus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Amoxicillin/clavulanate/Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Idoform Plus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'orally once daily', 'armGroupLabels': ['Amoxicillin/clavulanate/Idoform Plus']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'orally once daily', 'armGroupLabels': ['Amoxicillin/clavulanate/Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Danisco/Dupont', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}