Specific Carbohydrate Diet for Clostridium Difficile (SCD_cDiff)

David Suskind

Status: Completed

Conditions: Diet Modification; Clostridium Difficile Infection

Treatments: Dietary Supplement: Specific Carbohydrate Diet

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03925636

15858

Details and patient eligibility

About

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?

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 months to 21 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Dietary therapy for C. difficile colonization

Experimental group

Description:

Dietary therapy intervention for this arm is the Specific Carbohydrate Diet.

Treatment:

Dietary Supplement: Specific Carbohydrate Diet