Clostridioides Difficile Infection
Conditions
Keywords
Diet, Health counseling, Surveys, Stool samples
Brief summary
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. Counseling visits will be by phone or online videoconference (e.g. Zoom). Meals will be provided for two weeks and then participants will be asked to continue similar meals for 6 more weeks. Participants will provide responses to questionnaires and multiple stool samples over the course of the study. The goal is to understand how different health factors might impact the risk of becoming infected again with C. difficile in the future. Of note, this study will conceal the intervention details (type of diets) so that the control group does not increase their intake with the particular diet during the study. Participants in the control arm will be unblinded at the end of the study during a debrief with a member of the study team. At that time participants will be informed of diet being tested.
Interventions
OTHERHealth counseling sessions
Participant will have two health counseling visits with a member of the study team between weeks 2-8.
OTHERDiet (control diet)
Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
OTHERDiet (experimental diet)
Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
Sponsors
University of Michigan
Michigan Nutrition Obesity Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
The type of diet will be masked to the health counseling group.
Intervention model description
Participants will be randomized in a 1:1 ratio to one of the two groups and will be stratified by CDI therapy (vancomycin vs. fidaxomicin) to ensure balance between both arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Exclusion criteria
* 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing | Baseline, 2 weeks (post feeding period) | Change from baseline to week 2 (post feeding period) in alpha-diversity of fecal microbiome by 16S rRNA sequencing using Shannon index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA) | baseline to week 8 | Measured by Shannon Index via 16S rRNA. |
| Incidence of recurrent CDI | baseline to week 8 | Laboratory-confirmed symptomatic infection requiring treatment. |
| Change in CDI-related Quality of Life (QOL) baseline to Week 8 | Baseline to Week 8 | Patient-reported health-related quality of life assessed using the Clostridioides difficile Quality of Life Survey (Cdiff32) total score (range 0-100; higher scores indicate better quality of life). |
| Tolerability of diet based on the mean percent of meals consumed during the first 2 weeks | 2 weeks (during the provided meal period) | This is during the 2-weeks of receiving provided meals. |
Countries
United States
Contacts
CONTACTKira Newman, MD, PhD
PRINCIPAL_INVESTIGATORKira Newman, MD, PhD
University of Michigan
Outcome results
None listed