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Specific Carbohydrate Diet for Clostridium Difficile (SCD_cDiff)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03925636
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : July 11, 2022
Pacific Northwest National Laboratory
Information provided by (Responsible Party):
David Suskind, Seattle Children's Hospital

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 Intervention/treatment Phase
Clostridium Difficile Infection Diet Modification Dietary Supplement: Specific Carbohydrate Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
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 8, 2016
Actual Primary Completion Date : March 1, 2022
Actual Study Completion Date : March 1, 2022

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.

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 21 Years   (Child, Adult)
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925636

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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
David Suskind
Pacific Northwest National Laboratory
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Principal Investigator: David L Suskind, MD Seattle Children's Hospital and The University of Washington
  Study Documents (Full-Text)

Documents provided by David Suskind, Seattle Children's Hospital:
Informed Consent Form  [PDF] June 20, 2018

Additional Information:
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Responsible Party: David Suskind, Professor of Pediatrics, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03925636    
Other Study ID Numbers: 15858
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not discussed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Suskind, Seattle Children's Hospital:
Specific Carbohydrate Diet
Clostridium Difficile Infection
Clostridium Difficile
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses