Bethesda, MDNCT05333471Now EnrollingIRB Ready

Chronic Granulomatous Disease-associated Colitis Clinical Trial in Bethesda, MD

Access cutting-edge chronic granulomatous disease-associated colitis treatment through this phase 1/2 clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

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

Quick Self-Assessment

See if you qualify for this Bethesda location

Preparing your pre-screening questions…

Expert Care in Bethesda

Access chronic granulomatous disease-associated colitis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic granulomatous disease-associated colitis treatment provided free

Apply for This Bethesda Location

Check if you qualify for this chronic granulomatous disease-associated colitis clinical trial in Bethesda, MD

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Chronic Granulomatous Disease-associated Colitis Study in Bethesda

Background: Chronic granulomatous disease (CGD) weakens the body's defense against germs. CGD can also damage the colon. It can cause inflammation (colitis) that disrupts the good bacteria. Placing good bacteria from donor stool into the intestine of a person with CGD (called fecal microbiota transplantation, or FMT) may help. Objective: To see if FMT can reduce inflammation in the colon. Eligibility: People aged 10-60 who have CGD and colitis, and the treatments they have tried are not helping or have side effects. Design: Participants will have a telehealth screening visit. They will have a medical record review and medical history. They will collect stool samples at home and mail them to NIH. Participants will stay at the NIH hospital for 3-5 days. Each day, they will have the following: Physical exam Medical history and medicine review Surveys about CGD and how it affects their life Blood, stool, and urine tests Participants will have a colonoscopy. They will be sedated. A long, flexible tube will be inserted into their rectum. The tube will deliver the FMT material to their colon. Small samples of intestinal tissue will be collected. Participants may have an optional MRI of the digestive tract. Participants will have 9 follow-up telehealth visits over 6 months. They will be asked about their symptoms and side effects. They will fill out short surveys. They will collect stool and urine samples at home. Up to 2 visits can be done in person. At these visits, they may have the option to have an MRI and another colonoscopy to get more tissue samples. Participation will last for 6-7 months.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Aged \>=10 to \<=60 years.
Able to provide informed consent (for ages \>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 years).
Have confirmed prior diagnoses of CGD and CGD-AC (or CGD-IBD with evidence of colitis on colonoscopy).
Fecal calprotectin level \>=200 microgram/g.
HBI score \>=5 (to be evaluated on Day 1).
No planned change in systemic antibiotic regimen for CGD for 1 month preceding FMT.
No planned escalation in CGD-IBD treatment for 1 month preceding FMT.
If taking monoclonal antibodies for CGD-IBD, the dose must be stable for 12 weeks with no planned escalation.
Participants who can become pregnant must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy, starting at screening until the end of study participation. Highly effective methods include a barrier (eg, condom, diaphragm, cervical cap), intrauterine device, or hormonal contraception.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
Evidence of acute GI infection, including active GI abscesses.
Presence of C difficile toxin gene in stool, as identified by PCR, in screening period.
History of intestinal obstruction definitively related to CGD-IBD.
History of fistulizing CGD-IBD or CGD-IBD intra-abdominal abscesses.
History of CGD-IBD related non-transversable intestinal strictures.
History of AEs attributable to previous FMT.
History of significant liver disease (eg, biopsy-proven nodular regenerative hyperplasia), including portal hypertension or cirrhosis.
Pregnant or breastfeeding.
History of severe food allergy.
Any contraindication to having colonoscopy under anesthesia.
Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT05333471) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Granulomatous Disease-associated Colitis Treatment Options in Bethesda, MD

If you're searching for chronic granulomatous disease-associated colitis treatment options in Bethesda, MD, this clinical trial (NCT05333471) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced chronic granulomatous disease-associated colitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic granulomatous disease-associated colitis clinical trials near you to find additional studies recruiting in your area.

More Rheumatoid Arthritis Trials in Bethesda, MD

See all rheumatoid arthritis clinical trials recruiting in Bethesda — not just this study.

Browse Rheumatoid Arthritis Trials in Bethesda →

Browse More Trials by Condition

Rheumatoid Arthritis TrialsUlcerative Colitis TrialsAnkylosing Spondylitis TrialsSarcoidosis TrialsErectile Dysfunction TrialsInterstitial Cystitis TrialsAll Conditions →

Ready to Join in Bethesda?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · Bethesda, MD