Curcumin (Cur), an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively studied in the context of inflammatory diseases. Studies have demonstrated its efficacy in reducing chemically induced colitis in animal models and in humans. Berberine is a phytochemical derived from plants such as coptis chinensis, goldenseal and scutellaria. These herbal remedies have been used in both Chinese and European medicine for centuries to treat digestive inflammation and infectious diseases. Therefore the investigator see a possible dual mechanism of curcumin-Berberine (Coptis) treatment in SUDD patients through both direct anti-inflammatory action and modulation of intestinal microbiome. This data provides basis for investigating an integrative approach to optimize and offer treatment to patients suffering from post AD SUDD. The investigator speculate that using a combined gut-directed formulation of curcumin-Berberine could benefit this subgroup of patients and improve their clinical symptoms.
The objective of the study is to investigate the efficacy and safety of gut-directed enteric-coated curcumin-Berberine (Coptis) combination therapy to induce remission in patients suffering from post AD SUDD. Methods: This will be a two-stage study: Stage 1 will comprise an open label single arm exploratory study of 10 patients suffering from post AD SUDD investigating oral Cur-Berberine (Coptis) therapy for induction of clinical response. Stage 2: If clinical response is achieved in ≥ 3 patients and no significant safety signals will emerge, the investigator will proceed to a prospective pilot randomized placebo-controlled study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
dietary supplement
Placebo
Sheba Medical Center
Ramat Gan, Israel
RECRUITINGPercentage of patients reaching clinical response after initiation of therapy.
Clinical response is defined as a drop of ≥3 points of the DICS score.
Time frame: 8 weeks
Percentage of patients who had a clinical remission after initiation of therapy.
Clinical remission is defined as DICS score ≤ 5 within 4 weeks.
Time frame: 8 weeks
Percentage of patients who had a rapid clinical response after induction of therapy.
Clinical response is defined as a drop of ≥3 points of the DICS score
Time frame: 8 weeks
Percentage of patients who achieve normalization and/or >50% improvement of CRP and/or calprotectin levels (computed out of patients with abnormal values at baseline for these indices).
Calculation of the percentage of patients who achieve improvement of CRP
Time frame: 8 weeks
Time-to-response defined as number of days to achieve a drop of ≥3 points of the DICS score.
Within how many days the patient achieved drop of points in the DICS questionnaire
Time frame: 8 weeks
The percentage of patients in clinical remission at day 7 after induction of therapy.
Calculation of the percentage of patients achieved clinical remission at day 7
Time frame: Within 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.