Clinical trial NCT03925636: Specific Carbohydrate Diet for Clostridium Difficile
Official title: Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clostridium Difficile Infection
Diet Modification
Keywords: Specific Carbohydrate Diet
Clostridium Difficile Infection
Clostridium Difficile
cDiff
Diet
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Pacific Northwest National Laboratory
First posted: 2019-04-24
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with negative C. difficile stool
timeFrame: 12 weeks
measure: Number of participants able to maintain the specific carbohydrate diet
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital and The University of Washington
name: David L Suskind, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.