Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)
ConditionClostridioides Difficile Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Health counseling sessions
Other interventionParticipant will have two health counseling visits with a member of the study team between weeks 2-8.
Diet (control diet)
Other interventionParticipants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
Diet (experimental diet)
Other interventionParticipants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Experimental Diet plus health counselingExperimental treatment 1 intervention
Group B: Diet (control diet per protocol) plus health counselingOther 2 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 82
Incidence of recurrent CDI
Laboratory-confirmed symptomatic infection requiring treatment.
Time frame
baseline to week 83
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 84
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Michigan Nutrition Obesity Research Center
Collaborator
Source ClinicalTrials.gov