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| Name | Class |
|---|---|
| Pacific Northwest National Laboratory | FED |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary therapy for C. difficile colonization | Experimental | Dietary therapy intervention for this arm is the Specific Carbohydrate Diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific Carbohydrate Diet | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with negative C. difficile stool | 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. | 12 weeks |
| Number of participants able to maintain the specific carbohydrate diet | Diet diaries are reviewed to ascertain compliance to diet. Questionnaires are reviewed to determine barriers to implementing the diet. | 4 weeks |
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Inclusion Criteria:
Children and adolescents eighteen months old to twenty one years old
Diagnosis of C. difficile based upon stool antigen and toxin
Minimally active symptomatology based upon
Parent/guardian and child must be able to comprehend the consent and assent
Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12.
Patient must not have had antibiotic treatment directed at C. difficile for at least 1 week.
Exclusion Criteria:
Severe symptoms
Clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, and cystic fibrosis
Tobacco, alcohol or illicit drug abuse
Currently taking antibiotics at time of enrollment
Malnutrition as judged by the ratio of weight to height,
Clinical signs of dehydration(CD score>0)
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| Name | Affiliation | Role |
|---|---|---|
| David L Suskind, MD | Seattle Children's Hospital and The University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24048168 | Background | Suskind DL, Wahbeh G, Gregory N, Vendettuoli H, Christie D. Nutritional therapy in pediatric Crohn disease: the specific carbohydrate diet. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91. doi: 10.1097/MPG.0000000000000103. | |
| 30826445 | Background | Suskind DL, Lee D, Solan P, Wahbeh G, Hayden H, Brittnacher M, Nuding M, Miller S. Dietary therapy for clostridium difficile colonization: A case series. Anaerobe. 2019 Jun;57:1-3. doi: 10.1016/j.anaerobe.2019.02.016. Epub 2019 Feb 28. |
| Label | URL |
|---|---|
| Case Series of dietary therapy for recurrent c. difficile and colonization | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2018 | Apr 19, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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