Phase 2 Primary Biliary Cholangitis Trial, Completed NCT02424175 Sponsor: Brigham and Women's Hospital Condition: Primary Biliary Cholangitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, all of whom had a condition called primary sclerosing cholangitis (PSC), a disease affecting the bile ducts in the liver. All 10 participants completed the study. The trial was measuring three things: how often unwanted health events (called adverse events) occurred, whether a specific liver enzyme in the blood called alkaline phosphatase dropped by at least half after treatment, and whether the gut microbiome (the community of bacteria living in the digestive system) changed to become more similar to that of the donor. The reported data shows that out of the 10 participants, 8 experienced at least one adverse event of any level of seriousness. Regarding the alkaline phosphatase measure, the reported data shows that 3 out of 10 participants achieved a drop of 50% or more in their levels. For the microbiome outcome, the reported data shows that 8 out of 10 participants showed changes in their gut bacteria that made it more similar to the donor's microbiome after the procedure. It is worth noting that this was a very small study with only 10 participants, so the numbers reflect a limited group of people. No comparison group (such as a placebo group) was included in the reported data, meaning the figures above describe only what was observed in this single group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Primary Biliary Cholangitis Trial, Completed

NCT02424175
Completed Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have a confirmed diagnosis of Primary Sclerosing Cholangitis (PSC) — a liver condition — along with a diagnosis of inflammatory bowel disease
  • Your liver condition has been present for more than 6 months and has been confirmed by specific imaging of the bile ducts (confirm with trial site)
  • A specific liver-related blood marker (alkaline phosphatase) is significantly elevated above the normal range (confirm with trial site)

Who may not be able to join:

  • Your liver disease has reached an advanced or severe stage
  • You are currently pregnant or breastfeeding
  • You have taken certain immune-suppressing medications (such as methotrexate, cyclosporine, or tacrolimus) within the past 4 weeks
  • You are not able to give informed consent to participate
  • You are unable or unwilling to have a colonoscopy procedure under moderate sedation
  • You have previously had a Fecal Microbiota Transplant (FMT), which is the treatment being studied in this trial
  • You have a confirmed cancer or malignancy
  • Your immune system is weakened or compromised for any reason
  • You have taken certain specific anti-inflammatory medications (such as infliximab, adalimumab, or vedolizumab) within the last 8 weeks
  • You have taken antibiotics within the past 2 months
  • You are currently in, or have participated in, another clinical trial within the past 30 days
  • You have taken probiotic supplements within the past 30 days
  • You have an immune deficiency condition, whether present from birth or developed later in life
  • You have certain other health conditions including diabetes, lupus, or chronic kidney disease (confirm with trial site)
  • You have a history of heart valve disease, rheumatic heart disease, or endocarditis (an infection of the heart)
  • You are taking steroids at a dose greater than 20mg per day

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 February 2016
Est. completion
30 August 2017

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Adverse Event Frequency; Comparison of Alkaline Phosphatase Pre and Post Transplant

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov