Specific Carbohydrate Diet for Clostridium Difficile

NCT03925636 | Completed

• 1 other identifier: 15858
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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. 1.Is SCD effective for the treatment for Clostridium Difficile Colonization?
2. 2.Is the SCD well tolerated?

Conditions

Clostridium Difficile Infection; Diet Modification

Keywords

Specific Carbohydrate Diet; Clostridium Difficile Infection; Clostridium Difficile; cDiff; Diet

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Dietary therapy for C. difficile colonization

EXPERIMENTAL

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

Dietary Supplement: Specific Carbohydrate Diet

Interventions

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.

Dietary therapy for C. difficile colonization

Eligibility Criteria

• Age: 18 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• David Suskind: lead
• Pacific Northwest National Laboratory: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

• 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.

  PMID: 24048168 BACKGROUND

• 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.

  PMID: 30826445 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• David L Suskind, MD

  Seattle Children's Hospital and The University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 24, 2019
• Study Start: June 8, 2016
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)