The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation

2018-08-13 17:57:13 | BioPortfolio


The primary objective of this study is to compare the gut microbiota and clinical outcomes of oral FMT during antibiotic treatment, immediately following antibiotic treatment, and placebo. The second objective is to assess the safety and feasibility of daily oral Fecal Microbiome Transplant (FMT) as a treatment option.


Clostridium difficile is the most frequent bacterial cause of antibiotic-associated diarrhea. Those with a previous C. difficile infection (CDI) are at high risk of recurrent infection. Recurrent CDI often occurs when the normal gut microbiota are disrupted. Dysbiosis of the gut microbiota predisposes to CDI which, despite treatment can recur in 30% of patients. A novel way to prevent CDI recurrence is by instilling feces from a healthy individual into the intestine of the CDI patient, thereby restoring balance in the gut microbiota. However, it is unknown whether or not fecal microbiota transplantation (FMT) is an efficacious choice for CDI recurrence prevention when used concurrently with antibiotics. We propose a pilot randomized, double-blind placebocontrolled trial comparing oral FMT with placebo in patients with a history of CDI, currently undergoing antibiotic treatment. We will collect fecal samples from subjects prior to, during, and after FMT and collect metagenomics and microbiologic data on microbiota composition and function, and CDI recurrence. The trial's primary outcome is gut microbial composition and function. Secondary outcomes are feasibility and safety, and recurrent CDI during the trial period. In this 3 group study, FMT will be administered daily via oral capsules containing frozen fecal microbiota from universal donors in group 1, administered at the end of antibiotic treatment for group 2 and group 3 will receive placebo. The results of this study will provide the necessary pilot data to examine whether or not concurrent FMT in antibiotic treated patients who are at high risk for recurrent CDI can maintain a diverse healthy GI microbiota. If found to be effective, a trial evaluating the effect of concurrent FMT and antibiotic.

Study Design


Clostridium Difficile Infection


Low Dose FMT Capsule DE, Single Dose FMT Capsule DE, Placebo oral capsule


University of Wisconsin Hospital & Clinics
United States


Not yet recruiting


University of Wisconsin, Madison

Results (where available)

View Results


Published on BioPortfolio: 2018-08-13T17:57:13-0400

Clinical Trials [13261 Associated Clinical Trials listed on BioPortfolio]

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Norketotifen in Healthy Subjects

This is a Phase 1, single-center, double-blind, randomized, placebo-controlled, 2-part, single ascending dose and multiple dose cohort study of orally administered Norketotifen (NKT) in he...

A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo...

Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly Subjects

A three (3) part study to evaluate the safety, tolerability and PK of RDN-929

A Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects and the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics

A randomized, single-center, placebo and positive control, 4-period and 4-crossover clinical study with the following main purposes: (1) To evaluate the effect of a single-dose oral admini...

A Study of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)

The study is to evaluate the efficacy and safety of two doses of xiangjurupining capsule in Hyperplastic disease of breast patients .

PubMed Articles [15677 Associated PubMed Articles listed on BioPortfolio]


In order to estimate the anisotropy emission of 241Am-Be and 252Cf neutron sources from the Spanish Neutron Standards Laboratory (LPN/CIEMAT) detailed models of sources capsules and capsule holders we...

Genomic characterization of Haemophilus influenzae: a focus on the capsule locus.

Haemophilus influenzae (Hi) can cause invasive diseases such as meningitis, pneumonia, or sepsis. Typeable Hi includes six serotypes (a through f), each expressing a unique capsular polysaccharide. Th...

Contemporary Management of the Hip Capsule During Arthroscopic Hip Preservation Surgery.

The importance of the hip capsule and its effect on hip biomechanics, functional outcomes, and hip arthroscopy success rates has been demonstrated in recent studies. These results have led to a shift ...

Evaluation of Lens Capsule Stability Using Capsular Tension Ring, Iris Retractor, and Capsule Expander Using a Porcine Model With Zonular Dehiscence.

We evaluate the efficacy of capsular tension rings (CTRs), iris retractors (IRs), and capsule expanders (CEs) in stabilizing the lens capsule under different degrees of zonular dehiscence using a porc...

Understanding the Motion of Hard-shell Capsules in Dry Powder Inhalers.

The delivery of small drug particles from a dry powder inhaler (DPI) into the patient's peripheral airways requires the dispersion of the powder. In DPIs that contain a rotating pierced capsule, the c...

Medical and Biotech [MESH] Definitions

Clouding or loss of transparency of the posterior lens capsule, usually following CATARACT extraction.

Non-invasive, endoscopic imaging by use of VIDEO CAPSULE ENDOSCOPES to perform examination of the gastrointestinal tract, especially the small bowel.

A pill sized videocamera encased in a capsule. It is designed to be swallowed and subsequently traverse the gastrointestinal tract while transmitting diagnostic images along the way.

The sac enclosing a joint. It is composed of an outer fibrous articular capsule and an inner SYNOVIAL MEMBRANE.

Procedures performed to remove CAPSULE OPACIFICATION that develops on the POSTERIOR CAPSULE OF THE LENS following removal of a primary CATARACT.

More From BioPortfolio on "The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation"

Quick Search

Relevant Topics

Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...

Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Clostridium difficile (CDI)
A clostridium difficile infection (CDI) is a type of bacterial infection that can affect the digestive system. It most commonly affects people who are staying in hospital.  The symptoms of CDI can range from mild to severe and include: diarrhoe...

Searches Linking to this Trial