Evaluating a new oral treatment for mild-to-moderate Crohn's disease

Study to Evaluate Safety, Tolerability, and Early Efficacy of Oral E-B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease

This study is testing a new herbal pill to see if it can help people with mild-to-moderate Crohn's disease stay in remission when other treatments aren't working well.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT03992469 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and efficacy of an oral herbal formula, E-B-FAHF-2, in patients with mild-to-moderate Crohn's disease. The research aims to determine if this formula can effectively maintain remission in patients who currently have limited treatment options. Participants will be monitored for safety and clinical outcomes, with a focus on immunomodulatory effects. The study builds on previous findings from related research on food allergies and inflammatory bowel disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-60 with a diagnosis of mild-to-moderate Crohn's disease who are otherwise in good health.

Not a fit: Patients with severe Crohn's disease or those requiring immediate medical intervention are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with mild-to-moderate Crohn's disease, potentially improving their quality of life.

How similar studies have performed: While this approach is novel for Crohn's disease, related studies on herbal formulas for food allergies have shown promising results.

Eligibility criteria

Inclusion Criteria:

Participants must fulfill all of the following criteria to be eligible for inclusion in the study:

* Male and female subjects with Crohn's disease (CD), 18-60 years of age and otherwise in good health as determined by medical history and physical examination
* Subjects weighing 25kg or more
* History of ileal or ileal-colonic CD that is mild-to-moderate in severity as determined by standard history, physical, endoscopy scoring results, CD Activity Index (CDAI); patients with severe disease, which can be rapidly progressive and result in gastrointestinal hemorrhage, intestinal fistulas, abscesses and other complications, will be excluded because their risk of requiring rescue medications including steroids and biologicals as well as hospitalization or surgery are high.
* The subject is able to swallow the required capsules and tablets.
* The subject has been immunized according to the guidelines set forth by the CDC.
* The subject agrees to participate in the study.
* Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study.
* Evidence of inflammation on colonoscopy with an SES-CD \>3.
* Either an elevated fecal calprotectin or an elevated CRP.
* Willing and able to undergo upper endoscopy and colonoscopy with disease flares and after 6 months of treatment for the assessment of disease as per the standard of care for CD.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Subjects will be excluded from the study if any of the following apply:

* Patients with severe disease as determined by CDAI, or SES-CD scores at initial endoscopy of greater than 16, or strictures or large ulcerations on endoscopy that exemplify severe disease.
* Acute febrile illness within 1 week before administration of study therapeutic formula.
* Any history of other systemic diseases that, in the investigator's opinion, would preclude the subject from participating in this study, e.g. other autoimmune disease, neoplasm, HIV or hepatitis infection.
* Abnormal hepatic function (ALT, AST or bilirubin \>2 x upper limit of normal).
* Abnormal bone marrow function (WBC \<4 x 103/mm3; platelets \<100 x 103/mm3).
* Abnormal renal function (BUN and creatinine \>1.5 x upper limit of normal for age or abnormal eGFR for age and race).
* Clinically significant abnormal electrocardiogram.
* Participation in another experimental therapy study within 30 days of this study.
* History of alcohol or drug abuse.
* Pregnant or lactating female subjects: females of childbearing potential will need a negative pregnancy test at screening and at each visit to be considered and continued in this study. Lactating females will be excluded from the study.
* Active perirectal disease including fistuli or abcesses.
* Use of any other CAM products.
* Known allergy to FAHF-2/B-FAHF-2 or any of its components.
* Concurrent use of any medications known to alter CYP3A function.
* Any other medical concerns not listed above that in the invistigator's opinion may pose additional risks, interfere with adherence, or impact the quality or interpretation of the data.

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: David Dunkin, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Alana Mercurio, BA

Conditions Crohn's Disease; Entocort EC induction; double blind, controlled safety/tolerability trial; open label exploratory efficacy trial; mild-to-moderate crohn's disease; Chinese Herbal Therapy