Specific Carbohydrate Diet for Clostridium Difficile

Not Applicable

Completed

• Conditions: Clostridium Difficile Infection; Diet Modification
• Interventions: Dietary Supplement: Specific Carbohydrate Diet

• Registration Number: NCT03925636
• Lead Sponsor: David Suskind

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.

Study Timeline

• Study Start: 2016-06-08
• Study First Submitted: 2019-04-19
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-24
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary therapy for C. difficile colonization	Specific Carbohydrate Diet	Dietary therapy intervention for this arm is the Specific Carbohydrate Diet.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States