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

Tracking Information

• First Submitted Date: April 19, 2019
• First Posted Date: April 24, 2019
• Last Update Posted Date: July 11, 2022
• Actual Study Start Date: June 8, 2016
• Actual Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2019)

• 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.
• 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.

Original Primary Outcome Measures (submitted: April 19, 2019)

negative C. difficile [ Time Frame: 12 weeks ]

Negative, Toxigenic C difficile Negative by a Rapid Method

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Specific Carbohydrate Diet for Clostridium Difficile
• Official Title: Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Clostridium Difficile Infection
• Diet Modification

Intervention

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.

Study Arms

Experimental: Dietary therapy for C. difficile colonization

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

Intervention: Dietary Supplement: Specific Carbohydrate Diet

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 7, 2022): 4
• Original Estimated Enrollment (submitted: April 19, 2019): 5
• Actual Study Completion Date: March 1, 2022
• Actual Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Months to 21 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03925636
• Other Study ID Numbers: 15858
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Not discussed

• Current Responsible Party: David Suskind, Seattle Children's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: David Suskind
• Original Study Sponsor: Same as current
• Collaborators: Pacific Northwest National Laboratory

Investigators

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

• PRS Account: Seattle Children's Hospital
• Verification Date: July 2022