NCT03925636

Specific Carbohydrate Diet for Clostridium Difficile

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: David Suskind · Academic / Other
• Sex: All
• Age: 18 Months – 21 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-06-08
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2019-04-24
• Last updated: 2022-07-11

Locations

1 site across 1 country: United States