Specific Carbohydrate Diet for Clostridium Difficile

NCT ID: NCT03925636

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-08
• Study Completion Date: 2022-03-01

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.

Conditions

Clostridium Difficile Infection; Diet Modification

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dietary therapy for C. difficile colonization

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

Group Type: EXPERIMENTAL

Specific Carbohydrate Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacific Northwest National Laboratory

FED

Sponsor Role: collaborator

David Suskind

OTHER

Sponsor Role: lead

Responsible Party

David Suskind

Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David L Suskind, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital and The University of Washington

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24048168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30826445 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/30826445

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

Other Identifiers

15858

Identifier Type: -

Identifier Source: org_study_id