Clostridium Difficile InfectionSCD_cDiffNCT03925636
Specific Carbohydrate Diet for Clostridium Difficile
A study testing Specific Carbohydrate Diet in people with Clostridium Difficile Infection and Diet Modification, run by David Suskind at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 21 years
- Conditions the study is for
- Clostridium Difficile Infection, Diet Modification
- What is being tested?
- Specific Carbohydrate Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2016to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization
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?
Read the 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
- Being tested
- Specific Carbohydrate Diet
- Keywords
- Specific Carbohydrate Diet, Clostridium Difficile Infection, Clostridium Difficile, cDiff, Diet
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Carbohydrate DietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary therapy for C. difficile colonization | Experimental | Dietary therapy intervention for this arm is the Specific Carbohydrate Diet. Receives: Dietary Supplement: Specific Carbohydrate Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start8 Jun 2016
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Suskind
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific Northwest National Laboratory
- Responsible party
- Sponsor-investigator, David Suskind, Seattle Children's Hospital
- Investigators
- David L Suskind, MD, Principal investigator, Seattle Children's Hospital and The University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925636
- Sponsor's protocol ID
- 15858
- Acronym
- SCD_cDiff
- Status last verified
- Jul 2022
- First submitted
- 19 Apr 2019
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not discussed
Publications
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.
PubMed 24048168Suskind 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.
PubMed 30826445
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With the Specific Carbohydrate Diet for Children With Clostridium Difficile Colonization
- ClinicalTrials.gov ID
- NCT03925636
- Acronym / sponsor ID
- SCD_cDiff / 15858
- Conditions
- Clostridium Difficile Infection, Diet Modification
- Keywords
- Specific Carbohydrate Diet, Clostridium Difficile Infection, Clostridium Difficile, cDiff, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- David SuskindUniversity, hospital or other
- Collaborators
- Pacific Northwest National Laboratory
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary therapy for C. difficile colonization | Experimental | Dietary Supplement: Specific Carbohydrate DietDietary therapy intervention for this arm is the Specific Carbohydrate Diet. |
Who may qualify
- Ages
- 18 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- 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.
Key exclusion criteria (10 listed)
- Severe symptoms
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Carbohydrate DietThe 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 supplement | Dietary therapy for C. difficile colonization |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 24048168Suskind 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.
- Background: PubMed 30826445Suskind 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.
- Case Series of dietary therapy for recurrent c. difficile and colonizationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not discussed
Related trials for Clostridium Difficile Infection
Not yet recruitingPhase 1
A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile
Clostridium Difficile Infection
RecruitingPhase 1/2
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Clostridioides Difficile Infection, Recurrent Infection
RecruitingObservational study
Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Clostridium Difficile Infection, Clostridioides Difficile Infection
RecruitingPhase 2
ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence
RecruitingPhase 2
Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
Clostridioides Difficile Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Suskind, MD principal investigator
Seattle Children's Hospital and The University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Carbohydrate Diet in people with Clostridium Difficile Infection and Diet Modification, run by David Suskind at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with negative C. difficile stool (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03925636, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.