What side effects are associated with this type of intervention?

Common treatments for diverticulosis include dietary modifications, antibiotics, and in severe cases, surgery. Dietary changes, such as increasing fiber intake, generally have minimal side effects but can cause bloating and gas. Antibiotics can lead to side effects like nausea, diarrhea, and allergic reactions. Fecal Microbiota Transplantation (FMT), which is being studied for its potential in restoring a healthy gut microbiome, is generally well-tolerated but can cause mild gastrointestinal symptoms such as cramping, bloating, and diarrhea. Serious side effects are rare but can include infections and adverse reactions to the transplanted microbiota.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for diverticulosis itself, as the condition often does not require treatment unless complications arise. However, for related conditions involving gut microbiome restoration, Fecal Microbiota Transplantation (FMT) has been FDA-approved for the treatment of recurrent Clostridium difficile infections. This approach is being studied for its potential benefits in other gastrointestinal conditions, including diverticulitis, which is a complication of diverticulosis.

What other types of research exist?

Promising novel alternatives to Fecal Microbiota Transplantation for diverticulosis patients include the use of probiotics and synbiotics, which combine probiotics with prebiotics to enhance gut health. Additionally, dietary modifications such as increased fiber intake and the use of specific fiber supplements like psyllium may help manage symptoms. Emerging therapies also include the use of targeted antibiotics and anti-inflammatory agents to manage gut microbiota and inflammation.

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Microbiome Restoration

Fecal Microbiota Transplantation for Diverticulitis

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

The most common treatments for Diverticulosis focus on managing symptoms and preventing complications. One emerging treatment is Fecal Microbiota Transplantation (FMT), which aims to restore a healthy gut microbiome by transplanting fecal bacteria from a healthy donor to the patient. This is particularly relevant for Diverticulosis patients as alterations in the gut microbiome are believed to contribute to the condition. By restoring a balanced microbiome, FMT may reduce inflammation and improve gut health, potentially alleviating symptoms and preventing recurrent episodes. Other common treatments include dietary modifications, such as increasing fiber intake, and the use of probiotics to support gut health.

Phase < 1

Recruiting

Led By Justin A Maykel, MD

Research Sponsored by Justin Maykel

Eligibility Criteria Checklist

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

Must have

Recipient: One or more prior episode(s) of uncomplicated diverticulitis, as confirmed by imaging and clinical symptoms

Recipient: Eligible for surgical resection

Must not have

Donor: Gastrointestinal comorbidities

Recipient: Subjects <18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if FMT, which uses healthy donor stool to restore gut bacteria, can help patients with uncomplicated diverticulitis who have few other treatment options. FMT is commonly used to treat Clostridium difficile infection and is being explored for other conditions like inflammatory bowel disease.

Who is the study for?

This trial is for adults over 18 who have had at least one episode of uncomplicated diverticulitis, confirmed by imaging and symptoms. It's aimed at those eligible for surgical resection but are exploring other options.

What is being tested?

The study tests Fecal Microbiota Transplantation (FMT) as a treatment for diverticulitis. The goal is to see if transferring healthy gut bacteria into patients can improve their condition without surgery.

What are the potential side effects?

Potential side effects may include discomfort or infection at the transplant site, changes in bowel habits, abdominal pain, and possible allergic reactions to the transplanted material.

Eligibility Criteria

Inclusion Criteria

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

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I have had at least one episode of diverticulitis confirmed by tests.

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I am eligible for surgery to remove my cancer.

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I am older than 18 years.

Exclusion Criteria

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

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I have a history of gastrointestinal issues.

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I am under 18 years old.

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I have had major surgery in my stomach or abdomen area before.

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I have a history of diverticulitis.

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I have had a blockage in my intestines within the last year.

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I am unable to give informed consent by myself.

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I am currently experiencing a flare-up of diverticulitis.

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I have had a fecal transplant before.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

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

Treatment Details

Study Objectives

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

Primary study objectives

Necessity for surgery

Number of courses of antibiotics required for the treatment of diverticulitis since FMT

Number of diverticular flares/attacks since FMT

+1 more

Side effects data

From 2016 Phase 1 trial • 23 Patients • NCT02108821

48%

Abdominal Pain

22%

Diarrhea

22%

Flatulence and bloating

13%

Emesis

Nausea

Bloody stools

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Fecal Microbiota Transplantation

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: FMT cohortExperimental Treatment1 Intervention

This will be a single-arm pilot study of patients with uncomplicated diverticulitis. All subjects enrolled as recipients will undergo FMT via colonoscopy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplantation (FMT)

2016

Completed Phase 1

~170

0 / 12Eligibility 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

The most common treatments for Diverticulosis focus on managing symptoms and preventing complications. One emerging treatment is Fecal Microbiota Transplantation (FMT), which aims to restore a healthy gut microbiome by transplanting fecal bacteria from a healthy donor to the patient. This is particularly relevant for Diverticulosis patients as alterations in the gut microbiome are believed to contribute to the condition. By restoring a balanced microbiome, FMT may reduce inflammation and improve gut health, potentially alleviating symptoms and preventing recurrent episodes. Other common treatments include dietary modifications, such as increasing fiber intake, and the use of probiotics to support gut health.