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New treatment option for Clostridium Difficile Colitis
Official title Stool Transplants to Treat Refractory Clostridium Difficile Colitis
ClinicalTrials.gov ID: NCT02127398
What this study is testing
What is fecal microbiota?
fecal microbiota is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for clostridium difficile 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
- It has been shown that restoration of the normal makeup of the bowel bacterial population is the most effective way to treat recurrent colitis due to Clostridium difficile. Restoration of the normal bowel bacterial population is best done by transplanting stool from a healthy donor.
- 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 and older
You may be able to join if
- Study entry is open to adults (\>18 years old) who have had three of more episodes of Clostridium difficile colitis within the previous 12 months.
You likely can't join if
- Absolute neutrophil count \< 500 cells/mm3
- Active infection at other sites (excluding Clostridium difficile) requiring ongoing antibacterial therapy (antiviral or antifungal therapy is...
- Current or planned cytotoxic chemotherapy within 14 days of the potential fecal transplantation date
- Life expectancy \<180 days
- Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)
- Inability to swallow capsules
See the full eligibility criteria
- Study entry is open to adults (\>18 years old) who have had three of more episodes of Clostridium difficile colitis within the previous 12 months.
- Absolute neutrophil count \< 500 cells/mm3
- Active infection at other sites (excluding Clostridium difficile) requiring ongoing antibacterial therapy (antiviral or antifungal therapy is acceptable)
- Current or planned cytotoxic chemotherapy within 14 days of the potential fecal transplantation date
- Life expectancy \<180 days
- Diagnosis of inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)
- Inability to swallow capsules
- Indwelling nasogastric, orogastric, gastrostomy, or jejunostomy tube
- History of partial or total gastrectomy
- Short gut syndrome requiring total parenteral nutrition
- Pregnancy
- Documented intestinal parasite infection without documentation of appropriate treatment
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, 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.