Expired Study
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Houston, Texas 77007


Purpose:

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.


Criteria:

Inclusion Criteria: - Patients reporting persistent developmental disfluency. Exclusion Criteria: - Patients reporting no changes in disfluency severity or frequency


Study is Available At:


Original ID:

R2001AA


NCT ID:

NCT02547051


Secondary ID:


Study Acronym:


Brief Title:

Dietary Factors and Disfluency: A Look Into Food Allergies and Other Environmental Triggers Associated With Variations in Severity of Vocal Cord Tensi


Official Title:

Dietary Factors and Disfluency. A Look Into Causes and Variations in Severity of Disfluency in Regards to Vocal Cord Tension.


Overall Status:

Not yet recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

16 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The R2 Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Yohan R, Medical Doctor
9174096426
yohanrr@auamed.net

Study Dates

Start Date:January 2018
Completion Date:February 2022
Completion Type:Anticipated
Primary Completion Date:January 2021
Primary Completion Type:Anticipated
Verification Date:October 2017
Last Changed Date:October 10, 2017
First Received Date:September 8, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Dietary Factors and Disfluency: Variations in Severity of Vocal Cord tension
Time Frame:1 Year
Safety Issues:False
Description:Initial fluency samples are taken prior to treatment protocol of study. Food 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 subsequ

Study Interventions

Intervention Type:Other
Name:Food Allergy Testing and Elimination Diet
Description:Food allergy testing and elimination diet
Arm Name:Food allergy and vocal cord tension

Study Arms

Study Arm Type:Experimental
Arm Name:Food allergy and vocal cord tension
Description:To determine if dietary allergen responses and frequency and severity of vocal cord tension.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The R2 Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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