What side effects are associated with this type of intervention?

Common treatments for colitis include mesalamine, corticosteroids, and Fecal Microbiota Transplantation (FMT). Mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Corticosteroids are associated with side effects like weight gain, osteoporosis, hypertension, diabetes, and increased risk of infections. FMT, while generally considered safe, can lead to gastrointestinal symptoms such as diarrhea, cramping, and bloating, and there is a potential risk of transmitting infections. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for colitis that aim to manage inflammation and restore gut health. These include biologics like infliximab (Remicade) and adalimumab (Humira), which target specific components of the immune system to reduce inflammation. Immunomodulators such as azathioprine and 6-mercaptopurine are also used to suppress the immune response. While Fecal Microbiota Transplantation (FMT) is being studied for its potential to restore healthy gut microbiota in colitis patients, it is not yet FDA-approved for this indication. However, FMT has shown promise in clinical trials for conditions like Clostridioides difficile infection, highlighting its potential for broader applications in gut health restoration.

What other types of research exist?

Promising novel alternatives to Fecal Microbiota Transplantation for colitis patients include: 1) Low-FODMAP diet, which has shown efficacy in reducing gastrointestinal symptoms in inflammatory bowel disease (IBD) patients. 2) Specific Carbohydrate Diet (SCD) and Mediterranean Diet, both of which have demonstrated comparable remission rates in Crohn's disease and may be beneficial for colitis. 3) Probiotics, although current data do not strongly support their effectiveness, certain strains may still offer benefits. 4) Antibiotics like metronidazole and ciprofloxacin, which have shown modest benefits in managing Crohn's disease and may be applicable to colitis. 5) Nutritional therapy, including exclusive enteral nutrition (EEN) and supplemental enteral nutrition, which can promote mucosal healing and maintain remission.

← Back to Search

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation for Colitis

Q: What is the mechanism of action of this treatment?

Common treatments for colitis include anti-inflammatory drugs (such as mesalamine), corticosteroids, immunosuppressants, and biologics. These treatments work by reducing inflammation, suppressing the immune response, and targeting specific pathways involved in the inflammatory process. Fecal Microbiota Transplantation (FMT) is a treatment that aims to restore healthy gut microbiota by introducing beneficial bacteria from a donor's stool into the patient's colon. This can help rebalance the gut microbiome, reduce inflammation, and improve symptoms. For colitis patients, restoring a healthy gut microbiota is crucial as it can enhance the gut's barrier function, modulate the immune response, and potentially lead to long-term remission.

Phase 1 & 2

Recruiting

Led By Suchitra K Hourigan, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

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

Must have

Aged >=10 to <=60 years

Have confirmed prior diagnoses of CGD and CGD-AC (or CGD-IBD with evidence of colitis on colonoscopy)

Must not have

History of fistulizing CGD-IBD or CGD-IBD intra-abdominal abscesses

Evidence of acute GI infection, including active GI abscesses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if placing healthy bacteria from donor stool into the intestines of people with CGD and colitis can reduce inflammation. The target group is patients aged 10-60 who haven't responded to other treatments. The goal is to restore a healthy balance of gut bacteria to reduce inflammation. This method has shown promise in treating inflammatory bowel diseases like ulcerative colitis by restoring a healthy gut balance.

Who is the study for?

This trial is for people aged 10-60 with Chronic Granulomatous Disease (CGD) and colitis who haven't responded well to other treatments. They must have a specific level of inflammation marker in their stool, no recent changes in antibiotics or escalation in CGD treatment, and if they can get pregnant, agree to use effective contraception.

What is being tested?

The trial tests whether transplanting good bacteria from donor stool into the intestines (Fecal Microbiota Transplantation - FMT) can reduce colon inflammation in CGD patients. Participants will undergo various tests including a colonoscopy to deliver the FMT material and follow-up telehealth visits over 6 months.

What are the potential side effects?

Potential side effects may include discomfort or risks associated with colonoscopy procedures such as bleeding or perforation, reactions to sedatives used during the procedure, abdominal pain, bloating, diarrhea or constipation following FMT.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 10 and 60 years old.

Select...

I have been diagnosed with CGD and CGD-AC or CGD-IBD, with colitis confirmed by colonoscopy.

Exclusion Criteria

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

Select...

I have had complications from inflammatory bowel disease, like fistulas or abscesses.

Select...

I do not have an active infection in my digestive system.

Select...

I have had a blockage in my intestines due to CGD-related IBD.

Select...

I have a history of serious liver disease, such as cirrhosis.

Select...

I cannot have a colonoscopy with anesthesia due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Difference in fecal calprotectin pre FMT and within 1 month post FMT.

Secondary study objectives

Difference in PRO-2 pre-FMT and within 1 month post-FMT.

Differences in alpha diversity, beta diversity, and relative abundance of taxa pre-FMT within 1 month post-FMT and assessment of engraftment of donor microbiome and Assessment of engraftment of donor microbiome.

Treatment-Emergent Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionalExperimental Treatment1 Intervention

As this is a single arm study, this arm includes all participants. Participants will receive fecal microbiota transplantation (FMT) delivered by colonoscopy as a treatment for chronic granulomatous disease (CGD)-associated colitis (AC).

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colitis include anti-inflammatory drugs (such as mesalamine), corticosteroids, immunosuppressants, and biologics. These treatments work by reducing inflammation, suppressing the immune response, and targeting specific pathways involved in the inflammatory process. Fecal Microbiota Transplantation (FMT) is a treatment that aims to restore healthy gut microbiota by introducing beneficial bacteria from a donor's stool into the patient's colon. This can help rebalance the gut microbiome, reduce inflammation, and improve symptoms. For colitis patients, restoring a healthy gut microbiota is crucial as it can enhance the gut's barrier function, modulate the immune response, and potentially lead to long-term remission.

Efficacy and safety of fecal microbiota transplant for recurrent Clostridium difficile infection in inflammatory bowel disease: a systematic review and meta-analysis.