Phase 2
Completed N=8
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Source: ClinicalTrials.gov NCT02765256 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Change in Disease Activity by Harvey Bradshaw Index — -5; -3 score on a scale
Summary
To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) that is refractory to conventional, immunosuppressive therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Disease Activity by Harvey Bradshaw Index |
-5; -3 | — |
| PRIMARY Change in Disease Activity by Fecal Calprotectin (FCP) |
-16.5; -380.5 | — |
| SECONDARY The Change in High-sensitivity C-reactive Protein (hsCRP) |
4.1; -2 | — |
| SECONDARY Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs). |
31; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is capable of giving informed consent
- Males or females 18-75 years of age
- Normal kidney function (defined by normal serum creatinine [male: 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 350 mcg/g (within one month of enrollment)
- Have been treated with one of the following therapies** for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages.
Exclusion Criteria
- Known or suspected stricturing disease producing obstructive symptoms
- Active Clostridium difficile infection
- Unwillingness to provide informed consent
- Allergy or intolerance to the medications used in this study
- History of kidney disease
- History of liver disease
- Pregnant or lactating females
- Baseline QTc interval on EKG > 430 in males or > 450 in females
- Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Data sourced from ClinicalTrials.gov (NCT02765256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.