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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03992469
• Date of registration: 18/06/2019
• Prospective Registration: Yes
• Primary sponsor: Icahn School of Medicine at Mount Sinai
• Public title: Study to Evaluate Safety, Tolerability and Efficacy of Oral E-B-FAHF-2 in Mild-to-Moderate Crohn's Disease
• Scientific title: Study to Evaluate Safety, Tolerability, and Early Efficacy of Oral E-B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease
• Date of first enrolment: February 15, 2023
• Target sample size: 28
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03992469
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Alan Mercurio, BA

• Name: Alana Mercurio, BA

• Name: David Dunkin, MD
• Affiliation: Icahn School of Medicine at Mount Sinai

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: EBFAHF-2

Drug: Placebo

Primary Outcome(s)

Number of grades of adverse events [Time Frame: 8 months]

Secondary Outcome(s)

Fecal Calprotectin [Time Frame: 6 months]

Self Efficacy Scale: IBDSES [Time Frame: 6 months]

Immunologic Changes in PBMC cytokine levels [Time Frame: 6 months]

PROMIS Profile 29 [Time Frame: 6 months]

Number of participants requiring an escalation in therapy. [Time Frame: 6 months]

Secondary ID(s)

GCO 19-0125

0266-3308

Source(s) of Monetary Support

Please refer to primary and secondary sponsors