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Specific Carbohydrate Diet for Clostridium Difficile (SCD_cDiff)

Primary Purpose

Clostridium Difficile Infection, Diet Modification

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specific Carbohydrate Diet
Sponsored by
David Suskind
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Specific Carbohydrate Diet, Clostridium Difficile Infection, Clostridium Difficile, cDiff, Diet

Eligibility Criteria

18 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary therapy for C. difficile colonization

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2019
Last Updated
July 7, 2022
Sponsor
David Suskind
Collaborators
Pacific Northwest National Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT03925636
Brief Title
Specific Carbohydrate Diet for Clostridium Difficile
Acronym
SCD_cDiff
Official Title
Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 8, 2016 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Suskind
Collaborators
Pacific Northwest National Laboratory

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Is SCD effective for the treatment for Clostridium Difficile Colonization? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection, Diet Modification
Keywords
Specific Carbohydrate Diet, Clostridium Difficile Infection, Clostridium Difficile, cDiff, Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary therapy for C. difficile colonization
Arm Type
Experimental
Arm Description
Dietary therapy intervention for this arm is the Specific Carbohydrate Diet.
Intervention Type
Dietary Supplement
Intervention Name(s)
Specific Carbohydrate Diet
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with negative C. difficile stool
Description
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.
Time Frame
12 weeks
Title
Number of participants able to maintain the specific carbohydrate diet
Description
Diet diaries are reviewed to ascertain compliance to diet. Questionnaires are reviewed to determine barriers to implementing the diet.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Suskind, MD
Organizational Affiliation
Seattle Children's Hospital and The University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not discussed
Citations:
PubMed Identifier
24048168
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.
Results Reference
background
PubMed Identifier
30826445
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/30826445
Description
Case Series of dietary therapy for recurrent c. difficile and colonization

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Specific Carbohydrate Diet for Clostridium Difficile

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