Clostridium Difficile Infection, Diet Modification
Conditions
Keywords
Specific Carbohydrate Diet, Clostridium Difficile Infection, Clostridium Difficile, cDiff, Diet
Brief summary
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: 1. Is SCD effective for the treatment for Clostridium Difficile Colonization? 2. Is the SCD well tolerated?
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTSpecific 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.
Sponsors
Pacific Northwest National Laboratory
David Suskind
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Children and adolescents eighteen months old to twenty one years old 2. Diagnosis of C. difficile based upon stool antigen and toxin 3. Minimally active symptomatology based upon 1. 4 or less stools per day 2. No evidence of dehydration 3. No evidence of bandemia or hypoalbuminemia on screening labs 4. Parent/guardian and child must be able to comprehend the consent and assent 5. Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12. 6. Patient must not have had antibiotic treatment directed at C. difficile for at least 1 week.
Exclusion criteria
1. Severe symptoms 1. Abdominal pain that interrupts or inhibits normal activity 2. Fever 3. Vomiting 4. Blood in stool 2. Clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, and cystic fibrosis 3. Tobacco, alcohol or illicit drug abuse 4. Currently taking antibiotics at time of enrollment 5. Malnutrition as judged by the ratio of weight to height, 6. Clinical signs of dehydration(CD score\>0)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with negative C. difficile stool | 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 | 4 weeks | Diet diaries are reviewed to ascertain compliance to diet. Questionnaires are reviewed to determine barriers to implementing the diet. |
Countries
United States
Outcome results
None listed