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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
ICON-2 Trial 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.Check my eligibility
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.See study design
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.
ICON-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving a fecal transplant through a colonoscopy for C. diff infection.
Select...
I have been diagnosed with IBD (ulcerative colitis, Crohn's disease, or indeterminate colitis).
ICON-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clostridium difficile recurrence
Secondary outcome measures
Abdominal Pain
Diarrhea
Rectal bleeding
Side effects data
From 2022 Phase 3 trial • 148 Patients • NCT0318290721%
Febrile neutropenia
14%
Headache
14%
Pyrexia
13%
Vomiting
12%
Abdominal pain
8%
Alanine aminotransferase increased
7%
Hypokalaemia
7%
Thrombocytopenia
7%
Constipation
7%
Diarrhoea
7%
Stomatitis
7%
Aspartate aminotransferase increased
7%
Anaemia
7%
Neutropenia
7%
Nausea
5%
Oral herpes
4%
Staphylococcal bacteraemia
4%
C-reactive protein increased
4%
Leukopenia
3%
Cough
3%
Urinary tract infection
3%
Sepsis
3%
Septic shock
2%
Rhinitis
2%
Arthralgia
2%
Candida sepsis
2%
Bacteraemia
2%
Klebsiella bacteraemia
2%
Pneumonia
2%
COVID-19
1%
Upper respiratory tract infection
1%
Coronavirus infection
1%
Agranulocytosis
1%
Bone marrow failure
1%
Leukocytosis
1%
Drug hypersensitivity
1%
Cytomegalovirus infection
1%
Enterobacter bacteraemia
1%
Escherichia bacteraemia
1%
Fungal sepsis
1%
Gastroenteritis
1%
Neutropenic sepsis
1%
Nosocomial infection
1%
Pharyngotonsillitis
1%
Pneumonia aspiration
1%
Pseudomonal bacteraemia
1%
Pseudomonal sepsis
1%
Soft tissue infection
1%
Streptococcal bacteraemia
1%
SARS-CoV-2 test positive
1%
Hyponatraemia
1%
Myopathy
1%
Acute myeloid leukaemia
1%
Leukaemia
1%
Nystagmus
1%
Seizure
1%
Acute respiratory distress syndrome
1%
Respiratory tract oedema
1%
Venoocclusive disease
1%
Decreased appetite
1%
Dyspnoea
1%
Vancomycin infusion reaction
1%
Loss of consciousness
1%
Neurotoxicity
1%
Intussusception
1%
Graft versus host disease
1%
Acinetobacter sepsis
1%
Adenovirus infection
1%
Clostridium difficile colitis
1%
Neutropenic infection
1%
Serratia bacteraemia
1%
Anal inflammation
1%
Mucosal inflammation
1%
Biliary-bronchial fistula
1%
Urosepsis
1%
Urticaria
1%
Bacterial sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Bezlotoxumab
ICON-2 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
2016
Completed Phase 2
~350
Bezlotoxumab
FDA approved
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,757 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving a fecal transplant through a colonoscopy for C. diff infection.I am not infected with EBV or CMV and take 3 or more drugs for immune suppression.My doctor thinks some conditions or medications I have might make the treatment risky for me.Doctors think you might not live for more than 6 months.I have had a fecal microbiota transplant in the last year.I have had Clostridium difficile infection (CDI) at least twice.I am currently hospitalized but can be an outpatient for the colonoscopy.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I need to keep taking antibiotics that are not for C. diff infection.I am unable to understand or sign the consent form.I have been diagnosed with IBD (ulcerative colitis, Crohn's disease, or indeterminate colitis).You have a severe allergy to certain foods that can cause a life-threatening reaction.I am 18 years old or older.I have had surgery to remove my colon and rectum.I am expecting to have surgery within the next 30 days.I cannot or do not want to have a colonoscopy.I have severe heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: FMT + Bezlo
- Group 2: FMT + Placebo
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this research been attempted before?
"Ever since 2019, Merck Sharp & Dohme LLC have been sponsoring trials for Bezlotoxumab. After the initial 100-person study that year, this drug was granted its Phase 4 Drug Approval. Currently, there are four active studies taking place across two countries and three cities."
Answered by AI
What other research studies have made use of Bezlotoxumab?
"Currently, 4 clinical studies concerning bezlotoxumab are underway. None of these active trials have entered Phase 3, but they span 7 different medical centres - the majority located in Boston Massachusetts."
Answered by AI
What is the size of the participant pool for this trial?
"Affirmative. It is evident from the clinicaltrials.gov website that this medical trial, which was first posted on January 1st 2020 and last edited in July 2021, is actively recruiting 120 participants across one location."
Answered by AI
Is there an opportunity to join this trial for individuals seeking treatment?
"Per the clinicaltrials.gov database, this medical study is still open for recruitment and was initially posted on January 1st 2020 with the most recent update being recorded on July 19th 2021."
Answered by AI
Has regulatory approval been granted for Bezlotoxumab usage?
"Our team at Power assessed bezlotoxumab's safety as a level 2 due to the Phase 2 trial evidence, which suggests that it is safe but has not been proven effective."
Answered by AI
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