Low dose BFAHF-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

tablets are identical in appearance to BFAHF-2 tablets

Crohn's Disease

BFAHF-2 is a 0.55g circular tablet that is easy to swallow with a diameter of 0.44 inches and a thickness of 0.19 inches. The quality, safety and consistency of BFAHF-2 are established per FDA guidance under a botanical drug title. Low dose (maximum of 2 tablets bid) and full dose (maximum of 5 tablets bid). Weight based dosing will ensure an equivalent amount is given to each individual.

BFAHF-2

Placebo

Icahn School of Medicine at Mount Sinai

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

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

Safety and tolerance will be assessed by number of adverse events using a previously established grading system by the study team.

Before enrollment and at each visit a CDAI will be assessed. The CDAI is a clinical score for adults that includes history items, physical examination items, and laboratory tests and is based on the past 7 days. A score of <150 is defined as remission, 151-219 as mild activity, 220-450 as moderate activity and >450 as severe activity. Clinical response is defined as a decrease in score of at least 70 points or >25% in subjects with baseline CDAI >220.
Any escalations in therapy will be recorded and assessed as described above.

The level of calprotectin in stool as a way to detect inflammation in the intestines.

PROMIS Profile-29 is a validated, self-report collection of 4-item short forms that uses a 5-point Likert scale to assess anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities. PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured. Norm-based scores have been calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population(standard deviation=10).

This self-administered efficacy scale includes 13 items that assess how patients with IBD manage items related to their disease and everyday life. The validated scale uses 5-point Likert scales for each item. the total score ranges from 13 to 65 with a lower score indicating lower self-efficacy.

PBMCs will be obtained along with routine labs at the start of the safety trial and after starting (week 8), during (week 12 and 20) and completing the exploratory extension trial (week 32).

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

David Dunkin

Assistant Professor, Pediatrics

Safety and Tolerability phase is a double blind randomized controlled trial to evaluate safety and tolerability over 8 weeks. This is followed by an open-labeled exploratory efficacy extension phase for 6 months.

Double blind placebo controlled safety trial with random assignment to groups.

2 butanol/διάρροια

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

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