Specific Carbohydrate Diet for Clostridium Difficile (SCD_cDiff)
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|ClinicalTrials.gov Identifier: NCT03925636|
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : July 11, 2022
The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Clostridium Difficile Infection.
For this study, the investigators will be looking to determine:
- Is SCD effective for the treatment for Clostridium Difficile Colonization?
- Is the SCD well tolerated?
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Diet Modification||Dietary Supplement: Specific Carbohydrate Diet||Not Applicable|
The aim of this study is to determine the tolerability and potential efficacy of dietary therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with persistent antigen positivity due to C. difficile colonization with minimally active symptomatology. The goal of this pilot study is to gather preliminary data for a future treatment controlled trial of SCD versus standard medical therapy.
This is a single center, open labelled study designed to determine tolerability, preliminary safety and potential efficacy in pediatric patients with persistent C. difficile colonization with minimally active symptomatology. The study patients will be recruited from Seattle Children's Gastroenterology and Infectious Disease clinic.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization|
|Actual Study Start Date :||June 8, 2016|
|Actual Primary Completion Date :||March 1, 2022|
|Actual Study Completion Date :||March 1, 2022|
Experimental: Dietary therapy for C. difficile colonization
Dietary therapy intervention for this arm is the Specific Carbohydrate Diet.
Dietary Supplement: Specific Carbohydrate Diet
The diet removes all grains such as wheat, barley, corn, rice, and most dairy products (except yogurt fermented for 24 hours and cheese aged for grater than 30 days). The diet mainly consists of meat, fruits, vegetables, nuts, oils, and honey.
- Number of participants with negative C. difficile stool [ Time Frame: 12 weeks ]Stool is analyzed for C. difficile antigen and toxin by enzyme-linked immunosorbent assay (EIA). Samples that are antigen positive and toxin negative by EIA screen will be analyzed by the more sensitive polymerase chain reaction amplification (PCR) assay to detect C. difficile toxin.
- Number of participants able to maintain the specific carbohydrate diet [ Time Frame: 4 weeks ]Diet diaries are reviewed to ascertain compliance to diet. Questionnaires are reviewed to determine barriers to implementing the diet.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925636
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||David L Suskind, MD||Seattle Children's Hospital and The University of Washington|