An interventional study of Health counseling sessions and Diet (control diet) in Clostridioides Difficile Infection, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
This study's planned enrollment of 20 is below the median of 65 across 233 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
As stated earlier, the diet and intervention details will not be listed for concealment purposes.
Other: Diet (experimental diet)
As stated earlier, the diet and intervention details will not be listed for concealment purposes.
Other: Health counseling sessions · Other: Diet (control diet)
Participant will have two health counseling visits with a member of the study team between weeks 2-8.
Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing
Change from baseline to week 2 (post feeding period) in alpha-diversity of fecal microbiome by 16S rRNA sequencing using Shannon index.
Time frame: Baseline, 2 weeks (post feeding period)
Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA)
Measured by Shannon Index via 16S rRNA.
Time frame: baseline to week 8
Incidence of recurrent CDI
Laboratory-confirmed symptomatic infection requiring treatment.
Time frame: baseline to week 8
Change in CDI-related Quality of Life (QOL) 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).
Time frame: Baseline to Week 8
Tolerability of diet based on the mean percent of meals consumed during the first 2 weeks
This is during the 2-weeks of receiving provided meals.
Time frame: 2 weeks (during the provided meal period)
Plan to share: No
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