Specific Carbohydrate Diet for Clostridium Difficile

Diet Modification Clinical Trial

— SCD_cDiff  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925636
• Other study ID #: 15858
• Status: Completed
• Phase: N/A
• Start date: June 8, 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2022
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• 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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
David Suskind	Pacific Northwest National Laboratory

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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