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New treatment option for Chronic Granulomatous Disease-associated Colitis
Official title Fecal Microbiota Transplantation for Chronic Granulomatous Disease-Associated Colitis
ClinicalTrials.gov ID: NCT05333471
What this study is testing
What is MTP 101-LF?
MTP 101-LF is an investigational medicine, being studied as a potential treatment for chronic granulomatous disease-associated colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Chronic granulomatous disease (CGD) weakens the body's defense against germs. CGD can also damage the colon.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 60
You may be able to join if
- 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...
- Have confirmed prior diagnoses of CGD and CGD-AC (or CGD-IBD with evidence of colitis on colonoscopy).
- Fecal calprotectin level \>=200 microgram/g.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.