Oral E-B-FAHF-2 for Crohn's Disease

Overseen By David Dunkin, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: CAM products, CYP3A alterers

Disqualifiers: Severe disease, Autoimmune, Neoplasm, others

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with mild-to-moderate Crohn's disease, a condition that causes gut inflammation. The focus is on testing a herbal formula, B-FAHF-2 (also known as E-B-FAHF-2 or Butanol Purified Food Allergy Herbal Formula-2), to determine if it can safely help maintain remission, where symptoms are reduced or disappear. Participants will receive either the formula or a placebo, a harmless pill used for comparison. Suitable candidates for this trial include those with mild-to-moderate Crohn's disease who can swallow pills and are willing to undergo procedures like colonoscopy to monitor their condition. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any complementary and alternative medicine (CAM) products or medications that alter CYP3A function.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that E-B-FAHF-2, a herbal formula, has potential based on earlier studies. A less concentrated version, FAHF-2, proved safe and well-tolerated in people with food allergies. The FDA has approved this formula for testing in new areas.

In studies with B-FAHF-2, a stronger version, the treatment reduced inflammation markers in cells from patients with Crohn's disease. Importantly, B-FAHF-2 has been safely used in studies with children who have Crohn's, suggesting it could be safe for adults as well.

Although this trial is just beginning, past research on similar formulas has shown promise for safety. The goal is to determine if E-B-FAHF-2 can be a safe and helpful option for people with mild-to-moderate Crohn's disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about E-B-FAHF-2 for Crohn's disease because it offers a new approach compared to standard treatments like anti-inflammatory drugs and immune system suppressors. Unlike these options, E-B-FAHF-2 is derived from natural substances and potentially targets the immune system in a novel way, which could provide better symptom control with fewer side effects. Additionally, E-B-FAHF-2 is administered orally, making it a more convenient option for patients who struggle with other forms of medication. This combination of a unique mechanism and ease of administration makes E-B-FAHF-2 a promising candidate for improving Crohn's disease management.

What evidence suggests that E-B-FAHF-2 might be an effective treatment for Crohn's disease?

Research has shown that B-FAHF-2, a concentrated herbal formula, can help manage inflammation in Crohn's disease (CD). This trial will test B-FAHF-2, which reduces the activity of TNF-alpha, a protein that causes inflammation, along with other substances that lead to inflammation in the body. In lab tests, B-FAHF-2 lowered inflammation markers in cells from people with CD. The herbs in this formula have also been traditionally used to treat stomach problems like colitis. Although originally created for food allergies, early studies suggest it might help keep mild-to-moderate CD in remission. Participants in this trial will receive either B-FAHF-2 or a placebo to evaluate its effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

David Dunkin

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Adults aged 18-30 with recently diagnosed mild-to-moderate Crohn's disease, able to undergo endoscopy and colonoscopy. Participants must be in good health, able to swallow pills, immunized per CDC guidelines, and if female and of childbearing potential, using effective birth control. Exclusions include severe CD cases, abnormal organ function tests, concurrent strong medication interactions, other systemic diseases or experimental therapy within the last month.

Inclusion Criteria

I weigh at least 25kg.

Either an elevated fecal calprotectin or an elevated CRP.

Evidence of inflammation on colonoscopy with an SES-CD >3.

Exclusion Criteria

I haven't taken steroids, immunomodulators, or biologic medications in the last six months.

My liver tests are higher than normal.

Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Induction

Subjects are induced with Entocort EC for 8 weeks to assess response before enrollment in the trial

8 weeks

4 visits (in-person), phone contacts in between

Safety and Tolerability

Double blind, placebo controlled dose escalation trial of E-B-FAHF-2 in subjects who responded to induction therapy

8 weeks

4 visits (in-person), phone contacts in between

Open-label Extension

Exploratory extension trial of E-B-FAHF-2 monotherapy to ensure sub-chronic safety and assess efficacy

6 months

6 visits (in-person), 1 PK study visit for a subset of subjects

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BFAHF-2
• EBFAHF-2
• Placebo

Trial Overview The trial is testing E-B-FAHF-2 (a concentrated herbal formula) against a placebo for safety and effectiveness in maintaining remission of mild-to-moderate Crohn's disease. The study will also examine the effects on immune cells and intestinal mucosa to assess whether further efficacy trials are warranted.

How Is the Trial Designed?

Group I: E-B-FAHF-2 Experimental Treatment 1 Intervention

Low dose EBFAHF-2 (29 mg/kg/d divided two times a day) for 2 weeks followed by a full dose (71mg/kg/d divided two times a day) for 6 weeks

Group II: Placebo Placebo Group 1 Intervention

capsules are identical in appearance to EBFAHF-2 capsules

BFAHF-2 is already approved in United States for the following indications:

Approved in United States as B-FAHF-2 for:

• Investigational for Crohn's disease

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

B-FAHF-2, a refined version of Food Allergy Herbal Formula-2, effectively protects against peanut anaphylaxis in a mouse model, demonstrating safety and efficacy at a lower dosage than the original formula.

Berberine, a key component of B-FAHF-2, has low bioavailability when administered alone, but its absorption is significantly enhanced by other herbal constituents in the formula, indicating that these components work together to improve its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Berberine as a chemical and pharmacokinetic marker of the butanol-extracted Food Allergy Herbal Formula-2. Yang, N., Srivastava, K., Song, Y., et al.[2017]

In an extended phase I clinical trial involving 18 patients with food allergies, Food Allergy Herbal Formula-2 (FAHF-2) was found to be safe and well tolerated over a 6-month period, with no significant adverse effects on vital signs or laboratory parameters.

FAHF-2 treatment resulted in a significant reduction in basophil activation markers, indicating potential efficacy in modulating immune responses related to food allergies, and suggests further investigation in a controlled phase II study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study. Patil, SP., Wang, J., Song, Y., et al.[2022]

FAHF-2, a novel herbal formula based on traditional Chinese medicine, has shown effectiveness and safety in treating food allergies in mouse models, demonstrating persistent immune modulation even after treatment ends.

Early clinical trials indicate that FAHF-2 is well tolerated in humans, and an ongoing Phase II trial aims to confirm its efficacy in preventing allergic reactions during oral food challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of food anaphylaxis with traditional Chinese herbal remedies: from mouse model to human clinical trials. Wang, J.[2021]

FAHF-2, a 9-herb formula, was found to be safe and well tolerated in a study involving 68 participants with food allergies, with no serious adverse events reported.

While FAHF-2 showed favorable immunomodulatory effects in vitro, it did not demonstrate significant efficacy in improving tolerance to food allergens compared to placebo after 6 months of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy. Wang, J., Jones, SM., Pongracic, JA., et al.[2023]

The butanol-purified extract of Food Allergy Herbal Formula-2 (B-FAHF-2) significantly reduced the pill-load while maintaining efficacy, providing long-lasting protection against peanut anaphylaxis in a murine model for up to 50 weeks after treatment.

B-FAHF-2 demonstrated a high safety margin and effectively suppressed key immune responses associated with peanut allergy, including Th2 cytokines and IgE levels, indicating its potential as a safe therapeutic option for peanut allergy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety and immunological actions of butanol-extracted Food Allergy Herbal Formula-2 on peanut anaphylaxis. Srivastava, K., Yang, N., Chen, Y., et al.[2021]

In a phase 1 trial involving 19 food allergic participants, the herbal product FAHF-2 was found to be safe and well tolerated, with only mild gastrointestinal symptoms reported by one patient in each of the treatment and placebo groups.

The treatment with FAHF-2 led to a significant decrease in interleukin-5 levels, suggesting potential immunomodulatory effects that could benefit patients with food allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study. Wang, J., Patil, SP., Yang, N., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8672768/

Butanol Purified Food Allergy Herbal Formula-2 Has an ... Butanol purified food allergy herbal formula-2 has an immunomodulating effect ex-vivo in pediatric crohn's disease subjects.

2. crohnscolitisfoundation.org crohnscolitisfoundation.org/study-to-evaluate-safety-tolerability-and-early-efficacy-of-oral-e-b-fahf-2-subjects-with-mild-to

Study to Evaluate Safety, Tolerability, and Early Efficacy of ... E-B-FAHF-2 is an ethyl acetate butanol purified form of Food Allergy Herbal Formula-2 (FAHF-2) and is derived from the classical Therapeutic ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34926527/

Butanol Purified Food Allergy Herbal Formula-2 Has an ... Butanol Purified Food Allergy Herbal Formula-2 Has an Immunomodulating Effect ex-vivo in Pediatric Crohn's Disease Subjects. Front Med ...

4. semanticscholar.org semanticscholar.org/paper/Clinical-safety-of-Food-Allergy-Herbal-Formula-2-on-Patil-Wang/ebfb9c3d857934ad7793cda0e6464a541daca1ae

Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) ... Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study.

5. researchgate.net researchgate.net/publication/356698148_Butanol_Purified_Food_Allergy_Herbal_Formula-2_Has_an_Immunomodulating_Effect_ex-vivo_in_Pediatric_Crohn's_Disease_Subjects

(PDF) Butanol Purified Food Allergy Herbal Formula-2 Has ... B-FAHF-2 increased GM-CSF production by PBMCs and colonic mucosa from pediatric CD subjects including those with antibodies to GM-CSF. Of B-FAHF ...

6. researchgate.net researchgate.net/publication/51526565_Clinical_safety_of_Food_Allergy_Herbal_Formula-2_FAHF-2_and_inhibitory_effect_on_basophils_from_patients_with_food_allergy_Extended_phase_I_study

Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) ... Patients in an open-label study received 3.3 g (6 tablets) of FAHF-2 three times a day for 6 months. Vital signs, physical examination results, ...