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| Name | Class |
|---|---|
| Michigan Nutrition Obesity Research Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Diet plus health counseling | Experimental | As stated earlier, the diet and intervention details will not be listed for concealment purposes. |
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| Diet (control diet per protocol) plus health counseling | Other | As stated earlier, the diet and intervention details will not be listed for concealment purposes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health counseling sessions | Other | Participant will have two health counseling visits with a member of the study team between weeks 2-8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks (post feeding period) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 8 in microbiome alpha-diversity (Shannon Index via 16S rRNA) | Measured by Shannon Index via 16S rRNA. | baseline to week 8 |
| Incidence of recurrent CDI | Laboratory-confirmed symptomatic infection requiring treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kira Newman, MD, PhD | Contact | 734-615-4628 | kinewman@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kira Newman, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
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The type of diet will be masked to the health counseling group.
| 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. |
|
| 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). | 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. | 2 weeks (during the provided meal period) |