Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT01631461
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2012-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Painful Breastfeeding and Bacterial or Yeast Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008413', 'term': 'Mastitis'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2012-06-12', 'studyFirstSubmitQcDate': '2012-06-28', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacteria', 'timeFrame': 'Baseline (at admission)', 'description': 'Occurrence of bacteria: yes/no'}, {'measure': 'Yeast', 'timeFrame': 'Baseline (at admission)', 'description': 'Occurence of yeast: yes/no'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Baseline (at admission)', 'description': 'VAS'}, {'measure': 'Signs', 'timeFrame': 'Baseline (at admission)', 'description': 'Nipple areola: cracks, red/pink, flaky, shiny, blurred, swollen, itching, smarting'}, {'measure': 'Bacteria at follow-up', 'timeFrame': '2 weeks after baseline', 'description': 'Occurence of bacteria: yes/no'}, {'measure': 'Yeast at follow-up', 'timeFrame': '2 weeks after baseline', 'description': 'Occurence of yeast: yes/no'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'breast feeding', 'yeast', 'candida albicance', 'staphylococcus aureus', 'Signs and symptoms'], 'conditions': ['Breast Infection']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the prevalence of yeast and bacteria in women with breastfeeding pain and to identify signs and symptoms.', 'detailedDescription': 'Painful breastfeeding is one of the most common reasons for early weaning. Persistent pain associated with breastfeeding can sometimes be difficult to diagnose and is a source of frustration for the breastfeeding women as well as for healthcare providers.\n\nThe diagnosis of candida infection in breastfeeding women is generally based on signs and symptoms identified in case reports and without any culture. Breastfeeding pain has been described as superficial or deep in some studies. This deep pain syndrome as caused by candida or bacteria has been questioned. A few studies have cultured breast milk from women with deep breast pain and found Candida albicans infections or bacterial infections usually caused by Staphylococcus aureus. There still remains controversy and lack of evidence for candidiasis affecting the lactating breast as well as bacteria causing the pain. Ensured diagnostic methods are important due to the resistant problem with both antibiotics and antifungals. Only one study has described five key symptoms associated with candida. It was shiny, flaky nipple/areola, burning pain on the nipple/areola, non-stabbing pain or stabbing pain in the breast.\n\nThe objective of this study was to investigate the prevalence of candida and bacteria in women with superficial or deep breastfeeding pain and to identify signs and symptoms linked to candida or bacteria in breast milk and nipple/areola.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group 1 and 2: Selected from the breastfeeding receptions (n=2) at Sahlgrenska University hospital and Skövde hospital Group 3, controls: Selected from Primary health care clinics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scored pain \\> = VAS 4\n\nExclusion Criteria:\n\n* breastfeeding technique problems\n* clinical signs of mastitis\n* muscular pain\n* breast surgery\n* use of antibiotic or antifungal treatment during the last preceding week\n* temperature \\> = 37 degree Celsius'}, 'identificationModule': {'nctId': 'NCT01631461', 'briefTitle': 'Painful Breastfeeding and Bacterial or Yeast Infection', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'The Prevalence of Yeast and Bacteria in Women With Painful Breastfeeding and the Diagnostic Value of Signs and Symptoms', 'orgStudyIdInfo': {'id': 'PainBreastfeed'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1. Deep pain group', 'description': '1\\. Deep pain group; Pain in the breast'}, {'label': '2. Superficial pain group', 'description': 'Pain on the nipple and/or aereola'}, {'label': '3. Control group', 'description': 'No pain or other breastfeeding problems'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marie Berg, PhD,MPH,MNS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sahlgrenska Academy at University of Gothenburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}