Specific Carbohydrate Diet for Clostridium Difficile (SCD_cDiff)

Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization

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?

Study Overview

• Status: Completed
• Conditions: Diet Modification; Clostridium Difficile Infection
• Intervention / Treatment: Dietary supplement: Specific Carbohydrate Diet

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
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with negative C. difficile stool	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.	12 weeks
Number of participants able to maintain the specific carbohydrate diet	Diet diaries are reviewed to ascertain compliance to diet. Questionnaires are reviewed to determine barriers to implementing the diet.	4 weeks

Collaborators and Investigators

• Sponsor: David Suskind
• Collaborators: Pacific Northwest National Laboratory
• Investigators: Principal Investigator: David L Suskind, MD, Seattle Children's Hospital and The University of Washington

Publications and helpful links

General 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 19, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Diet; Clostridium Difficile; Specific Carbohydrate Diet; Clostridium Difficile Infection; cDiff
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections
• Other Study ID Numbers: 15858

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not discussed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No