CompletedNot Applicable

Specific Carbohydrate Diet for Clostridium Difficile

United States4 participantsStarted 2016-06-08

Plain-language 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?

Who can participate

Age range

18 Months – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with negative C. difficile stool

Timeframe: 12 weeks

Number of participants able to maintain the specific carbohydrate diet

Timeframe: 4 weeks

Trial details

NCT IDNCT03925636

SponsorDavid Suskind

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

View on ClinicalTrials.gov More Clostridium Difficile Infection trials

Plain-language summary

Who can participate

Age range

18 Months – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Specific Carbohydrate Diet for Clostridium Difficile

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Specific Carbohydrate Diet for Clostridium Difficile

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria