Chronic Heart FailurePhase 1IMTNCT07490054
Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
A Phase 1 study testing MTP-101-C encapsulated Microbiota, Vancomycin and Neomycin in people with Chronic Heart Failure, run by Melana Yuzefpolskaya, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine whether people with CHF, who often have different gut bacteria from healthy, would benefit from replacing their gut bacteria with healthy donor bacteria (also known as Intestinal Microbiota Transplantation - IMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- MTP-101-C encapsulated Microbiota, Vancomycin and Neomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to Nov 2027
- Phase
- Phase 1
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
- Diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Reduced Ejection Fraction (HFpEF), New York Heart Association Class II-IV
- On stable treatment for CHF for one month prior to enrollment
- Able to swallow capsules
- Able to provide blood sample and fecal sample
- Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and/or video visits or correspondence.
Who cannot join
- Dysphagia to pills
- Clinically active inflammatory bowel disease
- History of celiac disease
- Listed for transplant, and anticipated transplant listing or LVAD placement in the next 6 months
- Acute myocarditis
- Infiltrative and hypertrophic cardiomyopathies
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- Renal disease requiring dialysis
- Pregnancy or breastfeeding. A pregnancy test will be obtained from females of child-bearing potential at the screening visit or day 1 (prior to the receipt of IMT). Patients with a positive pregnancy test will be excluded. A negative result will be required for subjects who are females of child-bearing potential to receive IMT treatment. Patients will be counseled to avoid pregnancy which is the standard of care for patients with CHF.
- Life expectancy of < 6 months
- Presence of ileostomy or colostomy
- Patients on immunosuppressants (calcineurin inhibitors, prednisone ≥ 20 mg/day, methotrexate, azathioprine, immunosuppressive biologics, JAK inhibitors).
- Patients with neutropenia (an absolute neutrophil count < 0.5 x 109 cells/L) obtained on a complete blood count with differential at screening
- History of solid organ or bone marrow transplant
- Anticipated recurrent antibiotic use (patients with frequent urinary tract infections or sinusitis)
- History of severe anaphylactic food allergy
- Patients receiving cancer chemotherapy, immunotherapy, or radiation
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
Columbia University Irving Medical Center
New York, New York, 10032
Annamaria Ladanyi, MD, 212-342-6058, al4285@cumc.columbia.edu
Melana Yuzefpolskaya, MD
About this study
Official title: An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure
The purpose of this study is to determine whether people with CHF, who often have different gut bacteria from healthy, would benefit from replacing their gut bacteria with healthy donor bacteria (also known as Intestinal Microbiota Transplantation - IMT). IMT aims to restore healthy gut bacteria in patients with CHF, with previous studies showing its effectiveness, but further research is needed. IMT is an approved treatment for patients with infectious diarrhea. More than 10,000 IMTs are performed every year in the US. However IMT is not approved for patients with CHF, and thus considered investigational.
Read the detailed description
Hypothesis: CHF is thought to be partly mediated by inflammation. The primary hypotheses are anchored in the premise that the pathophysiology of CHF is in part driven by inflammation arising from low diversity, dysbiotic intestinal microbiota through at least three mechanisms including: i) enrichment of gram- negative lipopolysaccharide (LPS) producers; ii) enrichment of organisms with uremic toxin producing potential, particularly in the setting of impaired renal functional which is common in CHF; iii) depletion of short chain fatty acid producers (SCFA) which are known to be important anti-inflammatory molecules. The investigators hypothesize that IMT therapy will increase gut diversity, reduce inflammation and improve functional capacity and biomarkers of hemodynamic stress.
Phase of Clinical Trial: 1
Study Design and Participants: Single-center, open-label study for safety and feasibility of IMT in patients with CHF. After consent, individuals of the ages 18+ with a diagnosis of CHF not due to acute myocarditis or infiltrative disease, will be enrolled to receive antibiotic preconditioning for 7 days followed by IMT daily for additional 7 days. Prior to antibiotics and IMT, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT and antibiotic preconditioning, baseline blood and fecal samples will be collected, and patients will undergo a six-minute walk test, echocardiogram, and quality of life questionnaire (emPHasis-10, a validated short questionnaire to assess health-related quality of life in those with CHF). Additional fecal sample would be collected following 7 days of antibiotics preconditioning and prior to initiation of active IMT therapy. Patients will undergo follow-up either by phone, video or in-person visit, or online survey of symptoms on days 1-21, and then monthly up to 6 months post-IMT to screen for serious adverse events (SAEs) and adverse events (AEs). Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Blood samples and a fecal sample will be collected from participants on months one and six post-IMT to assess circulating inflammatory mediators and to assess for changes in recipient microbiome (engraftment kinetics). At six months, patients will also undergo repeat six-minute walk test, echocardiogram, and quality of life questionnaire when logistically possible and clinically indicated.
- Conditions
- Chronic Heart Failure
- Being tested
- MTP-101-C encapsulated Microbiota, Vancomycin, Neomycin
- Keywords
- Heart Failure, Intestinal Microbiota Transplantation, Heart Failure with Reduced Ejection Fraction, Heart Failure with Preserved Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP-101-C encapsulated MicrobiotaBiological
Also called MTP-101-C
Compound MTP-101-C was originally developed for treatment of the recurrent C. difficile infection syndrome (rCDI) following completion of anti-C. difficile antibiotic course. Fecal microbiota is prepared from stool of healthy human donors, who are screened and tested for infectious and non-infectious diseases. Raw stool is homogenized and filtered to separate the microbiota. The fecal microbiota is frozen in the presence of a lyoprotectant (trehalose), freeze-dried, and encapsulated into hypromellose capsules (DRcaps from Capsugel, Morristown, NJ). Each capsule contains ≥ 1 x 1011 and ≤ 2.0 x 1011 bacterial cells.
VancomycinDrug
glycopeptide antibiotic
NeomycinDrug
aminoglycoside antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Participants with Chronic Heart Failure (CHF) | Experimental | Antibiotic preconditioning: The antibiotic conditioning regimen will occur in the 7 days prior to IMT therapy. Antibiotic conditioning will consist of 250 mg of Vancomycin twice daily for 7 days + 500 mg of Neomycin twice daily for 7 days.
IMT dosing: A single dose consists of four, size 00 capsules of MTP-101C. An individual study participant will take the drug from a single lot only. Each lot contains microbiota separated and prepared from the stool of the individual donor and includes the dates of donation.
Each dose (four capsules) will be taken daily in the morning on an empty stomach. Clear liquids are allowed, and a regular breakfast can follow two hours later. Alternatively, the capsules can be taken after four hours of clear liquids, and no food other than clear liquids are allowed for two hours after the capsules are taken. The IMT treatment is administered for seven days. However, if the patient is hospitalized or wishes to stop the treatment, it will be stopped. Receives: Biological: MTP-101-C encapsulated Microbiota; Drug: Vancomycin; Drug: Neomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Safety will be measured by the number of adverse events that occur in participants.
Measured: Day 180
Study Drug Adherence
Study drug adherence (compliance) will be measured as the number of participants taking 100% (all doses) of the IMT.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 Oct 2025
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melana Yuzefpolskaya, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melana Yuzefpolskaya, MD, Columbia University
- Investigators
- Melana Yuzefpolskaya, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490054
- Sponsor's protocol ID
- AAAV0014
- Acronym
- IMT
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
PubMed 28785469Roger VL. Epidemiology of heart failure. Circ Res. 2013 Aug 30;113(6):646-59. doi: 10.1161/CIRCRESAHA.113.300268.
PubMed 23989710Francis GS, Benedict C, Johnstone DE, Kirlin PC, Nicklas J, Liang CS, Kubo SH, Rudin-Toretsky E, Yusuf S. Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure. A substudy of the Studies of Left Ventricular Dysfunction (SOLVD). Circulation. 1990 Nov;82(5):1724-9. doi: 10.1161/01.cir.82.5.1724.
PubMed 2146040Munger MA, Johnson B, Amber IJ, Callahan KS, Gilbert EM. Circulating concentrations of proinflammatory cytokines in mild or moderate heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 1996 Apr 1;77(9):723-7. doi: 10.1016/s0002-9149(97)89206-5.
PubMed 8651123Testa M, Yeh M, Lee P, Fanelli R, Loperfido F, Berman JW, LeJemtel TH. Circulating levels of cytokines and their endogenous modulators in patients with mild to severe congestive heart failure due to coronary artery disease or hypertension. J Am Coll Cardiol. 1996 Oct;28(4):964-71. doi: 10.1016/s0735-1097(96)00268-9.
PubMed 8837575Kummen M, Mayerhofer CCK, Vestad B, Broch K, Awoyemi A, Storm-Larsen C, Ueland T, Yndestad A, Hov JR, Troseid M. Gut Microbiota Signature in Heart Failure Defined From Profiling of 2 Independent Cohorts. J Am Coll Cardiol. 2018 Mar 13;71(10):1184-1186. doi: 10.1016/j.jacc.2017.12.057. No abstract available.
PubMed 29519360Khoruts A, Brandt LJ. Fecal Microbiota Transplant: A Rose by Any Other Name. Am J Gastroenterol. 2019 Jul;114(7):1176. doi: 10.14309/ajg.0000000000000286. No abstract available.
PubMed 31205129Colombo PC, Ganda A, Lin J, Onat D, Harxhi A, Iyasere JE, Uriel N, Cotter G. Inflammatory activation: cardiac, renal, and cardio-renal interactions in patients with the cardiorenal syndrome. Heart Fail Rev. 2012 Mar;17(2):177-90. doi: 10.1007/s10741-011-9261-3.
PubMed 21688186Kjekshus J, Apetrei E, Barrios V, Bohm M, Cleland JG, Cornel JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L, Hjalmarson A, Hradec J, Janosi A, Kamensky G, Komajda M, Korewicki J, Kuusi T, Mach F, Mareev V, McMurray JJ, Ranjith N, Schaufelberger M, Vanhaecke J, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J; CORONA Group. Rosuvastatin in older patients with systolic heart failure. N Engl J Med. 2007 Nov 29;357(22):2248-61. doi: 10.1056/NEJMoa0706201. Epub 2007 Nov 5.
PubMed 17984166Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G; Gissi-HF Investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Oct 4;372(9645):1231-9. doi: 10.1016/S0140-6736(08)61240-4. Epub 2008 Aug 29.
PubMed 18757089Mann DL, McMurray JJ, Packer M, Swedberg K, Borer JS, Colucci WS, Djian J, Drexler H, Feldman A, Kober L, Krum H, Liu P, Nieminen M, Tavazzi L, van Veldhuisen DJ, Waldenstrom A, Warren M, Westheim A, Zannad F, Fleming T. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL). Circulation. 2004 Apr 6;109(13):1594-602. doi: 10.1161/01.CIR.0000124490.27666.B2. Epub 2004 Mar 15.
PubMed 15023878Chung ES, Packer M, Lo KH, Fasanmade AA, Willerson JT; Anti-TNF Therapy Against Congestive Heart Failure Investigators. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-to-severe heart failure: results of the anti-TNF Therapy Against Congestive Heart Failure (ATTACH) trial. Circulation. 2003 Jul 1;107(25):3133-40. doi: 10.1161/01.CIR.0000077913.60364.D2. Epub 2003 Jun 9.
PubMed 12796126Ellekilde M, Selfjord E, Larsen CS, Jakesevic M, Rune I, Tranberg B, Vogensen FK, Nielsen DS, Bahl MI, Licht TR, Hansen AK, Hansen CH. Transfer of gut microbiota from lean and obese mice to antibiotic-treated mice. Sci Rep. 2014 Aug 1;4:5922. doi: 10.1038/srep05922.
PubMed 25082483Backhed F, Ding H, Wang T, Hooper LV, Koh GY, Nagy A, Semenkovich CF, Gordon JI. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci U S A. 2004 Nov 2;101(44):15718-23. doi: 10.1073/pnas.0407076101. Epub 2004 Oct 25.
PubMed 15505215Backhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. doi: 10.1073/pnas.0605374104. Epub 2007 Jan 8.
PubMed 17210919