Clostridium InfectionsPhase 2MDRO-FiberNCT07792915
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
A Phase 2 study testing Resistant Potato Starch and Maltodextrin in people with Clostridium Infections and Methicillin-resistant Staphylococcus Aureus (MRSA), run by VA Office of Research and Development at 1 site in United States.
Trial summary
Multidrug-resistant organisms (MDROs) cause serious infections that are difficult to treat, leading to increased morbidity and mortality, longer hospital stays, and increased healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococci
- What is being tested?
- Resistant Potato Starch and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Sep 2030
- Phase
- Phase 2
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
- Presence of C. difficile, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus (VRE), and/or Multi-drug resistant Enterobacteriaceae (MDRE) in the gut as determined by a stool test
- Ambulatory/not hospitalized at time of enrollment
Who cannot join
- Allergy to any ingredient or source material in intervention or placebo product
- Severe gastrointestinal condition that may be exacerbated by high dietary fiber intake (history of bowel obstruction, intestinal strictures, diverticulitis, active inflammatory bowel disease with structuring, gastroparesis, and/or severe gastrointestinal motility disorders)
- Uncontrolled diabetes (hospitalized in previous 5 years due to diabetes)
- Dysphagia
- Fecal microbiome transplant in the last 30 days
- Intestinal surgery in the last 30 days
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- Pregnancy or breastfeeding
- Immunosuppression, defined as history of solid organ transplant or as receipt of ablative chemotherapy, steroids at the equivalent of ≥5 mg/day prednisone, antimetabolites, anti-TNF agents, calcineurin inhibitors, or mycophenolate at time of enrollment
- Use of probiotics or fiber supplements in previous 30 days
- Already on a decolonization protocol
- Active infection requiring acute antibiotic treatment
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
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
Nasia Safdar, MD PhD, (608) 280-7007, Nasia.Safdar@va.gov
Nasia Safdar, MD PhD
About this study
Multidrug-resistant organisms (MDROs) cause serious infections that are difficult to treat, leading to increased morbidity and mortality, longer hospital stays, and increased healthcare costs. Many risk factors for MDRO infections are present in the Veteran population (such as older age, underlying medical conditions like diabetes, and stays in long-term healthcare settings). Some people can carry these organisms in their gut. Even without current symptoms, carrying these MDROs also increases risk of future infection. Effective, easy to use, and inexpensive interventions to reduce gut carriage of MDROs are needed to reduce risk of infection. Dietary fiber prebiotics have shown promise in improving the healthy gut microbiome, and the investigators have found that individuals with high fiber in their diets have reduced carriage of MDROs in the gut. The investigators propose a randomized controlled trial to test the effectiveness of a dietary fiber prebiotic intervention (resistant potato starch) in reducing gut MDRO carriage in Veterans with a history of MDRO carriage and/or infection. The investigators will also evaluate the effect on the gut microbiome as well as Veterans' experience with the fiber intervention.
Read the detailed description
Multidrug resistant organisms (MDROs) are resistant to antimicrobials and cause difficult to treat infections. MDRO infections thus lead to increased morbidity and mortality, increased length of stay, and higher medical costs. Colonization with an MDRO is also a risk factor for future infection. While decolonization of the skin is a straightforward and commonly used practice to prevent MDRO infections, gut colonization with MDROs is also a major risk factor but is much more difficult to modify. There is a critical gap in identification of effective, inexpensive, and easy to use interventions to reduce MDRO colonization and promote a healthy gut microbiome to reduce MDRO infections.
This project will address a novel approach to prevention: use of a dietary fiber prebiotic that is easily administered as a dietary supplement, inexpensive, and well-tolerated. While evidence suggests that prebiotics and dietary fiber have potential to promote healthy gut microbiomes and reduce MDRO colonization in the gut, there have not yet been any published studies in humans on the effect of dietary fiber prebiotic in reducing MDRO colonization.
The investigators will conduct a randomized, double-blind, placebo-controlled phase II clinical trial in 120 Veterans with a history of MDRO colonization and infection. Veterans will be randomized to a 5-week intervention period of either a dietary fiber intervention (resistant potato starch) or placebo. Participants will submit weekly stool samples during the intervention period, and one follow-up stool sample 3 months after completing treatment. Stool samples will be tested for presence of MDROs (primary outcome), and shotgun metagenomic sequencing and targeted metabolomics will be done to evaluate the gut microbiome (secondary outcomes: changes in metabolites and composition of the gut microbiome). Participants will also answer surveys about their experience with the intervention, including ease of use and tolerability.
- Conditions
- Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococci, Carbapenem-Resistant Enterobacteriaceae, Asymptomatic Infections
- Being tested
- Resistant Potato Starch, Maltodextrin
- Keywords
- Clostridioides, methicillin-resistant Staphylococcus aureus, Drug resistance, multiple, Gastrointestinal microbiome, Veterans, Dietary fiber, Prebiotics
- Medical subject headings
- Clostridium Infections, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistant Potato StarchDrug
Also called MSPrebiotic
MSPrebiotic (MSPrebiotic Inc, Carberry, Manitoba, Canada). MSPrebiotic is an unmodified resistant starch derived from potatoes (Solanar tuberosum). It consists of 20% amylose and 80% amylopectin forming granules the stomach and small intestine are unable to digest allowing for absorption in the colon. MSPrebiotic is consumed by mixing 10g into cold or room temperature foods or beverages; it is not to be heated.
MaltodextrinDrug
Also called Starch placebo control
The placebo will be 10 grams of digestible maltodextrin powder daily. Maltodextrin is a is a polysaccharide food additive and is white, tasteless, water-soluble powder making it a comparable placebo for the prebiotic. The placebo will be pharmaceutical grade and available over the counter.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Participants assigned to this arm will consume resistant potato starch prebiotic fiber powder as part of their standard diet for 5 weeks. On days 1-4 they will consume 4 grams (g) of product, on days 5-7 they will consume 7g of product, on days 8-35 they will consume 10g of product. Receives: Drug: Resistant Potato Starch |
| Placebo | Placebo comparator | Participants assigned to this arm will consume placebo (maltodextrin) powder as part of their standard diet for 5 weeks. On days 1-4 they will consume 4 grams (g) of product, on days 5-7 they will consume 7g of product, on days 8-35 they will consume 10g of product. Receives: Drug: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidrug resistant organism (MDRO) Decolonization
Changes in prevalence of MDRO carriage with one or more MDRO of interest: C. difficile, Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and/or multi-drug resistant Enterobacteriaceae (MDRE)
Measured: 3 years
Secondary outcomes (3)
Alpha-1-antitrypsin (AAT) levels
Changes in fecal AAT levels. AAT has been used successfully as a biomarker for intestinal permeability with higher concentrations of AAT in the gut indicating a leaky gut.
Measured: 3 years
Gut microbiome composition
The gut microbiome will be assessed using next generation sequencing (shotgun metagenomics)
Measured: 3 years
Changes in gut microbiome metabolites
Gut microbiome metabolites (short-chain fatty acids, secondary-bile acid producers) will be identified through next-generation sequencing technology and both targeted and untargeted metabolomics.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium InfectionsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to either the intervention (resistant potato starch prebiotic) or placebo.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Nasia Safdar, MD PhD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792915
- Sponsor's protocol ID
- INFA-002-25F
- Other IDs
- I01RD001117-01-A1
- Acronym
- MDRO-Fiber
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A BioProject will be created with NCBI and sequencing data will be shared there with a limited, deidentified set of metadata from participants. Additional data can be obtained from the research team with permissions.