Specific Carbohydrate Diet for Clostridium Difficile (NCT03925636) | Clinical Trial Compass
CompletedNot Applicable
Specific Carbohydrate Diet for Clostridium Difficile
United States4 participantsStarted 2016-06-08
Plain-language 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?
Who can participate
Age range18 Months – 21 Years
SexALL
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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.
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
✕
What they're measuring
1
Number of participants with negative C. difficile stool
Timeframe: 12 weeks
2
Number of participants able to maintain the specific carbohydrate diet