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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02547051
Other study ID # R2001AA
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 8, 2015
Last updated October 10, 2017
Start date January 2018
Est. completion date February 2022

Study information

Verified date October 2017
Source The R2 Institute
Contact Yohan R, Medical Doctor
Phone 9174096426
Email yohanrr@auamed.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date February 2022
Est. primary completion date January 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients reporting persistent developmental disfluency.

Exclusion Criteria:

- Patients reporting no changes in disfluency severity or frequency

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Food Allergy Testing and Elimination Diet
Food allergy testing and elimination diet

Locations

Country Name City State
United States R2 Institute Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The R2 Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dietary Factors and Disfluency: Variations in Severity of Vocal Cord tension 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 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.
1 Year