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Fecal Microbiota Transplantation

Fecal Microbiota Transplantation for Colitis

Q: Are there any openings left for participants in this research endeavor?

Information on clinicaltrials.gov shows that this research study is presently looking for candidates to join in the trial; it was posted on August 8th 2022 and last updated November 19th of the same year.

Q: Is candidacy for this experiment limited to individuals over fifty years of age?

Patients aged between 10 and 60 are being sought for this medical trial.

Q: How many participants are being enrolled in this trial?

Affirmative. According to clinicaltrials.gov, this medical trial is open for recruitment and was first posted on August 8th 2022. As of November 19th 2022, the study requires 20 participants from 1 site only.

Q: Which individuals are permitted to participate in this experiment?

This medical trial is searching for 20 participants, between the ages of 10 and 60, who are currently suffering from chronic granulomatous disorder. Qualified candidates must provide informed consent (if 18 years or older) or have a parent/guardian authorize them to join this study(for those under 18). Participants taking monoclonal antibodies must keep their dose steady during the preceding 12 weeks with no further increases planned. Should someone in the trial become pregnant they will be required to use reliable forms of contraception until the end of their participation in research. Lastly, <a href="https://www.withpower.com/clinical-trials/all">all</a> potential subjects should possess confirmed prior diagnoses of CGD-AC and

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 month

Awards & highlights

Study Summary

This trial is testing whether fecal microbiota transplantation (FMT) can reduce inflammation in the colon for people with chronic granulomatous disease (CGD).

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.Check my eligibility

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.See study design

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.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

3,269 Previous Clinical Trials

5,481,449 Total Patients Enrolled

10 Trials studying Colitis

2,831 Patients Enrolled for Colitis

Suchitra K Hourigan, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

3 Previous Clinical Trials

630 Total Patients Enrolled

1 Trials studying Colitis

Media Library

OpenBiome FMT product FMP250 (Fecal Microbiota Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT05333471 — Phase 1 & 2

Colitis Research Study Groups: Interventional

Colitis Clinical Trial 2023: OpenBiome FMT product FMP250 Highlights & Side Effects. Trial Name: NCT05333471 — Phase 1 & 2

OpenBiome FMT product FMP250 (Fecal Microbiota Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333471 — Phase 1 & 2

Frequently Asked Questions

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

Are there any openings left for participants in this research endeavor?

"Information on clinicaltrials.gov shows that this research study is presently looking for candidates to join in the trial; it was posted on August 8th 2022 and last updated November 19th of the same year."

Answered by AI

Is candidacy for this experiment limited to individuals over fifty years of age?

"Patients aged between 10 and 60 are being sought for this medical trial."

Answered by AI

How many participants are being enrolled in this trial?

"Affirmative. According to clinicaltrials.gov, this medical trial is open for recruitment and was first posted on August 8th 2022. As of November 19th 2022, the study requires 20 participants from 1 site only."

Answered by AI

Which individuals are permitted to participate in this experiment?

"This medical trial is searching for 20 participants, between the ages of 10 and 60, who are currently suffering from chronic granulomatous disorder. Qualified candidates must provide informed consent (if 18 years or older) or have a parent/guardian authorize them to join this study(for those under 18). Participants taking monoclonal antibodies must keep their dose steady during the preceding 12 weeks with no further increases planned. Should someone in the trial become pregnant they will be required to use reliable forms of contraception until the end of their participation in research. Lastly, all potential subjects should possess confirmed prior diagnoses of CGD-AC and"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis

2022. "Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05333471.

All > Colitis