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Microbiome Modulator

FMT + Bezlotoxumab for IBD and C. Difficile Infection (ICON-2 Trial)

Phase 2

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing FMT via colonoscopy for CDI as part of standard medical care

Confirmed diagnosis of IBD (ulcerative colitis, Crohn's disease or indeterminate colitis)

Must not have

Patient who have received an FMT in the past year

EBV or CMV negative if a patient is severely immunosuppressed (defined as 3 or more immunosuppressing agents)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing whether FMT (fecal microbiota transplantation) plus bezlotoxumab is better than FMT plus placebo for treating IBD (inflammatory bowel disease) and CDI (clostridium difficile infection). Up to 150 patients will be enrolled, and they will be followed for 3 months.

Who is the study for?

This trial is for adults over 18 with inflammatory bowel disease (IBD) and recurrent Clostridium difficile infection (CDI), who are undergoing fecal microbiota transplantation (FMT) as standard care. Participants must have had at least two CDI episodes, but not received FMT in the past year or be pregnant/breastfeeding. Those with severe allergies, life expectancy under six months, or certain medical conditions are excluded.

What is being tested?

The ICON-2 trial tests if adding Bezlotoxumab to FMT is more effective than FMT with a placebo in treating IBD patients with CDI. Up to 150 participants will be randomly assigned to either treatment group and monitored for three months using stool and blood samples along with clinical data.

What are the potential side effects?

Potential side effects of Bezlotoxumab may include allergic reactions, heart-related issues, fatigue, headache, fever, gastrointestinal discomforts like nausea or constipation. The risks associated with fecal microbiota transplantation typically include mild abdominal discomfort and bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am receiving a fecal transplant through a colonoscopy for C. diff infection.

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I have been diagnosed with IBD (ulcerative colitis, Crohn's disease, or indeterminate colitis).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a fecal microbiota transplant in the last year.

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I am not infected with EBV or CMV and take 3 or more drugs for immune suppression.

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I cannot or do not want to have a colonoscopy.

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I need to keep taking antibiotics that are not for C. diff infection.

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I have had surgery to remove my colon and rectum.

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I am unable to understand or sign the consent form.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Clostridium Difficile Recurrence

Secondary study objectives

Abdominal Pain

Diarrhea

Rectal bleeding

Side effects data

From 2022 Phase 3 trial • 148 Patients • NCT03182907

21%

Febrile neutropenia

14%

Pyrexia

14%

Headache

13%

Vomiting

12%

Abdominal pain

Alanine aminotransferase increased

Hypokalaemia

Neutropenia

Nausea

Aspartate aminotransferase increased

Anaemia

Thrombocytopenia

Stomatitis

Diarrhoea

Constipation

Oral herpes

Leukopenia

Staphylococcal bacteraemia

C-reactive protein increased

Urinary tract infection

Cough

Sepsis

Septic shock

Bacteraemia

Rhinitis

Arthralgia

Pneumonia

Klebsiella bacteraemia

COVID-19

Candida sepsis

Nystagmus

Serratia bacteraemia

Hyponatraemia

Leukocytosis

Escherichia bacteraemia

Pharyngotonsillitis

Pseudomonal bacteraemia

Loss of consciousness

Venoocclusive disease

Vancomycin infusion reaction

Myopathy

Neurotoxicity

Acute respiratory distress syndrome

Dyspnoea

Urosepsis

Enterobacter bacteraemia

Coronavirus infection

Upper respiratory tract infection

Acute myeloid leukaemia

Respiratory tract oedema

Graft versus host disease

SARS-CoV-2 test positive

Decreased appetite

Mucosal inflammation

Streptococcal bacteraemia

Cytomegalovirus infection

Leukaemia

Seizure

Neutropenic infection

Neutropenic sepsis

Nosocomial infection

Biliary-bronchial fistula

Drug hypersensitivity

Acinetobacter sepsis

Adenovirus infection

Clostridium difficile colitis

Pneumonia aspiration

Agranulocytosis

Bone marrow failure

Anal inflammation

Intussusception

Pseudomonal sepsis

Bacterial sepsis

Fungal sepsis

Gastroenteritis

Soft tissue infection

Urticaria

100%

80%

60%

40%

20%

Study treatment Arm

Bezlotoxumab

Placebo

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FMT + BezloExperimental Treatment2 Interventions

Patients in this arm will received an FMT via colonoscopy ( 250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that will take place over 60 mins.

Group II: FMT + PlaceboPlacebo Group2 Interventions

Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplantation

2020

Completed Phase 2

~440

Bezlotoxumab

FDA approved