Bezlotoxumab for Inflammatory Bowel Diseases

Phase-Based Estimates
1
Effectiveness
2
Safety
Brigham and Women's Hospital, Boston, MA
Inflammatory Bowel Diseases+5 More
Bezlotoxumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Inflammatory Bowel Diseases

Study Summary

This study is evaluating whether fecal microbiota transplantation (FMT) may help treat patients with inflammatory bowel disease and Clostridium difficile infection.

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Eligible Conditions

  • Inflammatory Bowel Diseases
  • Infections
  • Colitis, Pseudomembranous
  • Clostridium Infections
  • Intestinal Diseases
  • Enterocolitis, Pseudomembranous
  • Clostridium Difficile Infection (CDI)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Bezlotoxumab will improve 1 primary outcome and 3 secondary outcomes in patients with Inflammatory Bowel Diseases. Measurement will happen over the course of 8 weeks.

12 weeks
Abdominal Pain
Diarrheal symptoms
Rectal bleeding
8 weeks
Clostridium difficile recurrence

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

FMT + Placebo
FMT + Bezlo
Placebo group

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bezlotoxumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

FMT + BezloPatients 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.
FMT + PlaceboPatients 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
Bezlotoxumab
FDA approved
Fecal Microbiota Transplantation
2016
Completed Phase 2
~330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Who is running the study

Principal Investigator
J. R. A.
Jessica Ravikoff Allegretti, Director, Fecal Microbiota Transplantation Program
Brigham and Women's Hospital

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Inflammatory Bowel Diseases or one of the other 5 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults age 18 or greater
History of ≥ 2 episodes of recurrent CDI. CDI is defined as the presence of diarrhea ( Bristol 6 or 7 for 48 hours and a confirmatory test for CDI). Preferred testing will be a two-step method using GDH/EIA toxin, though PCR will be accepted based on hospital availability with confirmation of the most recent episode occurring within the prior 3 months
Confirmed diagnosis of IBD (ulcerative colitis, Crohn's disease or indeterminate colitis)
Undergoing FMT via colonoscopy for CDI as part of standard medical care

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get inflammatory bowel diseases a year in the United States?

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Approximately 450,000 people have IBD annually in the United States. The prevalence of IBD is higher in the United States than other regions of the world.

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Can inflammatory bowel diseases be cured?

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Despite the high level of agreement among experts' results, the degree of cure of patients with moderate to severe IBD is not as good as that for patients with mild IBD.

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What are the signs of inflammatory bowel diseases?

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Symptoms of IBD are present from birth. Patients with question: What can we say about the impact of a physical examination on care planning? answer: Physical examination was not a useful adjunct to a question: Do patients'expectations of treatment have any predictive value? answer: Patients did not have significant expectations of benefit from a physical examination.

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What is inflammatory bowel diseases?

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Inflammatory bowel disease can be divided into ulcerative colitis and Crohn disease. Only in 5%, each of ulcerative colitis (UC) and Crohn disease (CD) are the indications for surgery (mainly ileocaecal resection and total colectomy). On the other hand, 5-year mortality is 5% for UC and 10% for CD. The main prognostic factor is a short time interval from diagnosis to follow-up visit due to the long-lasting effects of the diseases. The lifetime risk of developing UC in a Caucasian is 1.9 and 2.5 in a Danish population.

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What are common treatments for inflammatory bowel diseases?

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While there is no effective treatment for irritable bowel syndrome, common treatments generally work well, and many patients have a good long-term outcome. However, certain patients may have a limited benefit from treatment and many patients benefit less from treatment.

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What causes inflammatory bowel diseases?

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Many different autoimmune diseases may be triggers for Crohn's disease, Ulcerative colitis and/or a combination of them. Infections and immune changes during pregnancy may be the triggering factors in Crohn's disease. Allergic reactions may also be a cause for Crohn's disease. Also, a chronic viral or bacterial infection (chronic hepatitis B virus and Epstein-Barr virus infections in particular) may cause a Crohn's-like disorder. Allergic diseases such as allergic bronchopulmonary aspergillosis and hypersensitivity angiotensin II-converting enzyme inhibitors) may act merely as a trigger of inflammatory bowel diseases. Also, infections may be a trigger of ulcerative colitis.

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Has bezlotoxumab proven to be more effective than a placebo?

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There are four clinical trials showing proof of concept for the effectiveness of bezlotoxumab, and three trials showed efficacy beyond that of a placebo, when the clinical effect was assessed according to MTC1 guidelines recommended by IBD European task force.

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How serious can inflammatory bowel diseases be?

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Most patients did not seek medical care for their inflammatory bowel disease. Patients with IBD who did seek treatment are likely hospitalized and have complications more often than patients without IBD. They are also more likely to have comorbidities and poor health-related quality of life.

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Who should consider clinical trials for inflammatory bowel diseases?

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Most IBD clinical trials are in adult patients. Younger patients are more likely to have a disease that's more dangerous and more likely to progress. Patients in critical care settings are also more likely to be enrolled in trials. For future clinical trials in IBD, a more rigorous approach should be used to exclude the aforementioned patients with risk factors and identify the most appropriate age group.

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Is bezlotoxumab safe for people?

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In our population bezlotoxumab was well tolerated and demonstrated improvements in both depression and bowel function during the treatment period. More participants had good response on anxiety, and overall there was no statistically significant increase in adverse events. Future controlled studies combining bezlotoxumab with standard therapy, should be conducted in order to validate further these results.

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Does bezlotoxumab improve quality of life for those with inflammatory bowel diseases?

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Bezlotoxumab treatment did not improve quality of life compared with placebo in patients with moderate-to-severe ulcerative colitis or Crohn's disease. Results from a recent paper are reassuring for patients and a new indication for bezlotoxumab.

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Have there been other clinical trials involving bezlotoxumab?

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Clinical trials are underway involving bezlotoxumab, such as bezlotoxumab in patients with moderate to severe Crohn's disease (CD) and moderate to severe ulcerative colitis (UC). It is anticipated that clinical trials on bezlotoxumab may open new perspectives on the treatment of inflammatory bowel diseases.

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