Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-02 @ 1:52 PM
Study NCT ID:
NCT02547051
Status:
UNKNOWN
Last Update Posted:
2017-10-11
First Post:
2015-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tension.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092724', 'term': 'Elimination Diets'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2015-09-08', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary Factors and Disfluency: Variations in Severity of Vocal Cord tension', 'timeFrame': '1 Year', 'description': 'Initial fluency samples are taken prior to treatment protocol of study.\n\nFood sensitivity panel will be assessed for potential allergans. Allergan responses are graded from 0 being no response to food allergen to 3 being the strongest response and subsequent removal of sensitive allergan from diet. Speech sample and disfluency severity will be evaluated qualitatively again via the SSI-3 on repeat office visit at fixed interval scale. Erickson S-24 repeated at end of study and final conclusions made.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vocal Cord Tension', 'Dysfluency Developmental']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see whether participants with persistent developmental disfluency who report fluctuational disfluency due to vocal cord tension on a day to day basis of can achieve a more normalized fluency by identifying dietary allergen responses and subsequently eliminating these dietary triggers from their daily consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients reporting persistent developmental disfluency.\n\nExclusion Criteria:\n\n* Patients reporting no changes in disfluency severity or frequency'}, 'identificationModule': {'nctId': 'NCT02547051', 'briefTitle': 'Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tension.', 'organization': {'class': 'OTHER', 'fullName': 'The R2 Institute'}, 'officialTitle': 'Dietary Factors and Disfluency. A Look Into Causes and Variations in Severity of Disfluency in Regards to Vocal Cord Tension.', 'orgStudyIdInfo': {'id': 'R2001AA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Food allergy and vocal cord tension', 'description': 'To determine if dietary allergen responses and frequency and severity of vocal cord tension.', 'interventionNames': ['Other: Food Allergy Testing and Elimination Diet']}], 'interventions': [{'name': 'Food Allergy Testing and Elimination Diet', 'type': 'OTHER', 'description': 'Food allergy testing and elimination diet', 'armGroupLabels': ['Food allergy and vocal cord tension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77007', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'R2 Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Yohan R, Medical Doctor', 'role': 'CONTACT', 'email': 'yohanrr@auamed.net', 'phone': '9174096426'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The R2 Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}