BridgeMD
New treatment option for Crohn Disease
Official title Standardized Microbiota Transplant Therapy in Crohn's Disease
ClinicalTrials.gov ID: NCT06631586
What this study is testing
What is MTP-101C?
MTP-101C is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn disease.
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
- Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Able and willing to provide informed consent.
- 18-89 years of age.
- English speaking.
- Diagnosis of CD based on typical clinical and histologic features.
- Active disease on endoscopy:
You likely can't join if
- Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.
- Documented gastroparesis
- History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.
- Symptomatic stricture defined as a stricture that:
- Cannot be traversed by the colonoscope,
- Requires intervention to be traversed,
See the full eligibility criteria
- Able and willing to provide informed consent.
- 18-89 years of age.
- English speaking.
- Diagnosis of CD based on typical clinical and histologic features.
- Active disease on endoscopy:
- SES-CD \>= 6
- SES-CD \>= 4 for isolated ileal disease
- Current CD therapies are in the maintenance phase of dosing at the time of randomization.
- Any ongoing CD therapy (apart from steroid use) must be at stable doses for 4 weeks prior to randomization and remain stable over study course.
- Steroid use 20mg or less by 5 days prior to randomization.
- Steroid use stipulations:
- Prednisone must be tapered below 20mg after 7 days.
- Any use of budesonide over the study period is allowed although tapering is encouraged.
- Rescue medications: Steroid courses (up to 40mg for two weeks with a planned taper) are allowed at the discretion of the treating provider. Study drug therapy will be stopped on a case-by-case basis on discussion with...
- Women who are not post-menopausal (at least 12 months of non-therapy induced amenorrhea) or surgically sterile (e.g., absence of ovaries and/or uterus) must remain abstinent or use a highly effective form of birth...
- Able to comply with study measures in the opinion of the investigator.
- Extensive bowel resection: i.e., subtotal colectomy or substantial removal of small bowel where short bowel syndrome could be a concern.
- Documented gastroparesis
- History of pylorus non-preserving gastric surgery, e.g., Roux-en-Y gastric bypass.
- Symptomatic stricture defined as a stricture that:
- Cannot be traversed by the colonoscope,
- Requires intervention to be traversed,
- Is otherwise responsible for the predominant clinical picture, in the opinion of the investigator.
- Presence of ileostomy or colostomy.
- Entero-vesicular fistula (i.e., fistula from bowel to bladder).
- Suspicion of ischemic colitis, radiation colitis or microscopic colitis.
- Diagnosis of ulcerative colitis.
- Active or untreated infection.
- Adenomatous polyps that have not been removed.
- Use of antibiotics within 14-days of randomization.
- Current pregnancy.
- Current breastfeeding or planning to breastfeed over the study period.
- History of anaphylactic food allergies.
- End stage liver disease or cirrhosis.
- Anticipated need for antibiotics over the study period.
- Anticipated surgical procedure over the study period.
- An absolute neutrophil count \<500 cell/µL.
- Diagnosis of a primary immunodeficiency.
- Active malignancy requiring the use of chemotherapeutic agent (except for localized non-melanomatous skin cancers).
- Patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies.
- Any solid organ transplant within 6 months of randomization.
- Use of chimeric antigen receptor T-cell therapy or hematopoietic cell transplant within the past 12 months
- Life expectancy \<=6 months.
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
- New York, New York, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States; New York, New York, 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.