Specific Carbohydrate Diet for Clostridium Difficile

Study Overview
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Brief Summary
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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: Is SCD effective for the treatment for Clostridium Difficile Colonization? Is the SCD well tolerated?

Detailed Description
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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.

Official Title
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Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization

Conditions
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Clostridium Difficile Infection, Diet Modification

Intervention / Treatment
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* Dietary Supplement: Specific Carbohydrate Diet


Participation Criteria
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Eligibility Criteria
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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 4 or less stools per day No evidence of dehydration No evidence of bandemia or hypoalbuminemia on screening labs 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 Abdominal pain that interrupts or inhibits normal activity Fever Vomiting Blood in stool 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)

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary therapy for C. difficile colonization<br>Dietary therapy intervention for this arm is the Specific Carbohydrate Diet. | Dietary Supplement: Specific Carbohydrate Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Specific Carbohydrate Diet, Clostridium Difficile Infection, Clostridium Difficile, cDiff, Diet