Specific Carbohydrate Diet for Clostridium Difficile (SCD_cDiff)

• ClinicalTrials.gov Identifier: NCT03925636
• Recruitment Status: Completed
• First Posted: April 24, 2019
• Last Update Posted: July 11, 2022
• Sponsor: David Suskind
• Collaborator: Pacific Northwest National Laboratory
• Information provided by (Responsible Party): David Suskind, Seattle Children's Hospital

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	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.

Study Design

• 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

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 Months to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Sponsors and Collaborators

David Suskind

Pacific Northwest National Laboratory

Investigators

• 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

More Information

Additional Information:

Case Series of dietary therapy for recurrent c. difficile and colonization 

Publications:

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.

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.

• 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
• 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

• 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; cDiff; Diet

Additional relevant MeSH terms:

Clostridium Infections; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses