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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Specific Carbohydrate Diet for Clostridium Difficile

Clinicaltrials.gov identifier NCT03925636

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted March 18, 2020

Study Description

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?

  • Condition or Disease:Diet Modification
    Clostridium Difficile Infection
  • Intervention/Treatment: Dietary Supplement: Specific Carbohydrate Diet
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 5 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization
  • Actual Study Start Date: June 2016
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: January 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Dietary therapy for C. difficile colonization
Dietary therapy intervention for this arm is the Specific Carbohydrate Diet.
Dietary Supplement: Specific 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.
Outcome Measures
  • Primary Outcome Measures: 1. Number of participants with negative C. difficile stool [ Time Frame: 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.
  • 2. Number of participants able to maintain the specific carbohydrate diet [ Time Frame: 4 weeks ]
    Diet diaries are reviewed to ascertain compliance to diet. Questionnaires are reviewed to determine barriers to implementing the diet.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 21 Months (Child)
  • Sexes Eligible for Study: All
  • Accepts 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

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)

Contacts and Locations

Contact: Mason E Nuding 206-987-0055 mason.nuding@seattlechildrens.org

Contact: Clinical Research Coordinator 206-987-2521 giresearch@seattlechildrens.org


United States, Washington
Seattle Children's Hospital

Sponsors and Collaborators

David Suskind

Pacific Northwest National Laboratory


Principal Investigator: David L Suskind, MD Seattle Children's Hospital and The University of Washington

More Information