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New treatment option for Clostridioides Difficile Infection
Official title Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)
ClinicalTrials.gov ID: NCT07613645
What this study is testing
- What it's testing
- This study aims to evaluate the impact of diet on the gut microbiome in adults with Clostridioides difficile infection (CDI). Eligible participants will be randomized and receive meals plus different types of health counseling.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Non-recurrent non-fulminant CDI (laboratory-confirmed C. difficile infection without prior C. difficile infection within 3 months and no shock...
- Currently receiving treatment or with plan to initiate treatment for CDI
- CDI treatment with standard regimen (fidaxomicin 200milligrams (mg) by mouth (PO) twice a day x 10-14 days or vancomycin 125mg PO 4 x a day (QID) x...
You likely can't join if
- Chemotherapy, immunotherapy, or transplant within 12 months
- Colon not in continuity (i.e. status post total colectomy or with current ileostomy)
- Medical comorbidities requiring specific fluid, sodium, or protein intake level outside range of prepared diet options
- Baseline diet with \> 11grams fiber/1000 kilocalories
- Low sodium diet, vegan diet, gluten-free diet, Kosher diet or any other diet not able to be accommodated by the metabolic kitchen
- Allergies, food preferences, or other restrictions not able to be accommodated by the metabolic (note: lactose intolerance will not impact...
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Non-recurrent non-fulminant CDI (laboratory-confirmed C. difficile infection without prior C. difficile infection within 3 months and no shock, hypotension, ileus, or megacolon)
- Currently receiving treatment or with plan to initiate treatment for CDI
- CDI treatment with standard regimen (fidaxomicin 200milligrams (mg) by mouth (PO) twice a day x 10-14 days or vancomycin 125mg PO 4 x a day (QID) x 10-14 days)
- No prior advanced therapy for C. difficile (i.e. prolonged antibiotic therapy, bezlotoxumab, fecal transplant, other microbial therapy)
- Chemotherapy, immunotherapy, or transplant within 12 months
- Colon not in continuity (i.e. status post total colectomy or with current ileostomy)
- Medical comorbidities requiring specific fluid, sodium, or protein intake level outside range of prepared diet options
- Baseline diet with \> 11grams fiber/1000 kilocalories
- Low sodium diet, vegan diet, gluten-free diet, Kosher diet or any other diet not able to be accommodated by the metabolic kitchen
- Allergies, food preferences, or other restrictions not able to be accommodated by the metabolic (note: lactose intolerance will not impact eligibility)
- Unwilling to stop probiotic supplements during the study period
- Current antibiotic therapy that will continue after CDI treatment has finished
- Hospitalized or in skilled nursing facility at time of CDI treatment conclusion
- Pregnancy or breast-feeding
- Unable to provide a stool sample of appropriate quality for further analysis (i.e. low volume, adulterated, delayed return, etc.)
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.