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Completed

NCT Number: NCT03925636

Specific Carbohydrate Diet for Clostridium Difficile

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?

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Key information

Age range

18 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents eighteen months old to twenty one years old
  • Diagnosis of C. difficile based upon stool antigen and toxin
  • Minimally active symptomatology based upon
  • 4 or less stools per day
  • No evidence of dehydration
  • No evidence of bandemia or hypoalbuminemia on screening labs
  • Parent/guardian and child must be able to comprehend the consent and assent
  • Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12.
  • Patient must not have had antibiotic treatment directed at C. difficile for at least 1 week.

Exclusion criteria

  • Severe symptoms
  • Abdominal pain that interrupts or inhibits normal activity
  • Fever
  • Vomiting
  • Blood in stool
  • Clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, pneumonia), immunodeficiency, underlying severe chronic diseases, and cystic fibrosis
  • Tobacco, alcohol or illicit drug abuse
  • Currently taking antibiotics at time of enrollment
  • Malnutrition as judged by the ratio of weight to height,
  • Clinical signs of dehydration(CD score>0)

Treatment and study plan

Specific Carbohydrate Diet

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

David Suskind

Other

Collaborators

  • Pacific Northwest National Laboratory

Registry information

Official study title

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

Acronym: SCD_cDiff

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2019
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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