Clostridioides Difficile InfectionNCT07613645
Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)
A study testing Health counseling sessions and Diet (experimental diet) in people with Clostridioides Difficile Infection, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- Health counseling sessions and Diet (experimental diet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Kira Newman, MD, PhD, 734-615-4628, kinewman@med.umich.edu
Kira Newman, MD, PhD
About this study
Official title: Diet for Prevention of Recurrent C. Difficile Infection
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.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- Health counseling sessions, Diet (control diet), Diet (experimental diet)
- Keywords
- Diet, Health counseling, Surveys, Stool samples
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health counseling sessionsOther
Participant will have two health counseling visits with a member of the study team between weeks 2-8.
Diet (control diet)Other
Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
Diet (experimental diet)Other
Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Diet plus health counseling | Experimental | As stated earlier, the diet and intervention details will not be listed for concealment purposes. Receives: Other: Diet (experimental diet) |
| Diet (control diet per protocol) plus health counseling | Other | As stated earlier, the diet and intervention details will not be listed for concealment purposes. Receives: Other: Health counseling sessions; Other: Diet (control diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks (post feeding period)
Secondary outcomes (4)
Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA)
Measured by Shannon Index via 16S rRNA.
Measured: baseline to week 8
Incidence of recurrent CDI
Laboratory-confirmed symptomatic infection requiring treatment.
Measured: 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).
Measured: 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.
Measured: 2 weeks (during the provided meal period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start5 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Nutrition Obesity Research Center
- Responsible party
- Principal investigator, Kira Newman, University of Michigan
- Investigators
- Kira Newman, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613645
- Sponsor's protocol ID
- HUM00284257
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet for Prevention of Recurrent C. Difficile Infection
- ClinicalTrials.gov ID
- NCT07613645
- Acronym / sponsor ID
- HUM00284257
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Diet, Health counseling, Surveys, Stool samples
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Nutrition Obesity Research Center
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Diet plus health counseling | Experimental | Other: Diet (experimental diet)As stated earlier, the diet and intervention details will not be listed for concealment purposes. |
| Diet (control diet per protocol) plus health counseling | Other | Other: Health counseling sessions, Other: Diet (control diet)As stated earlier, the diet and intervention details will not be listed for concealment purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health counseling sessionsParticipant will have two health counseling visits with a member of the study team between weeks 2-8. | Other | Diet (control diet per protocol) plus health counseling |
| Diet (control diet)Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks. | Other | Diet (control diet per protocol) plus health counseling |
| Diet (experimental diet)Participants will receive 2 weeks of prepared meals. Participants will then be asked to follow a similar diet for 6 weeks. | Other | Experimental Diet plus health counseling |
Primary outcome
Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing
Time frame: 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.
4 secondary outcomes
Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA)
Time frame: baseline to week 8
Incidence of recurrent CDI
Time frame: baseline to week 8
Change in CDI-related Quality of Life (QOL) baseline to Week 8
Time frame: Baseline to Week 8
Tolerability of diet based on the mean percent of meals consumed during the first 2 weeks
Time frame: 2 weeks (during the provided meal period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kira Newman, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health counseling sessions and Diet (experimental diet) in people with Clostridioides Difficile Infection, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kira Newman, MD, PhD (734-615-4628, kinewman@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 2 in alpha-diversity of fecal microbiome by 16S rRNA sequencing (time frame: Baseline, 2 weeks (post feeding period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.