Clinical trial NCT05596214: Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (SUDD)
Official title: Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (AD) Symptomatic Uncomplicated Diverticular Disease (SUDD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diverticulitis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 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, we will proceed to a prospective pilot randomized placebo-controlled study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Established diagnosis of previous acute diverticulitis (AD) and on-going abdominal symptoms comprising a SUDD (left abdominal pain and/or change in bowel habits and bloating)
2. Having an active SUDD defined by Diverticular Clinical Score (DICS) score ≥10.
3. Age 18-80 years.
4. Able and willing to give written consent

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Exclusion Criteria:

1. Patient with non-controlled renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, uncontrolled migraines or neurological disorders
2. Patients with significant laboratory abnormalities, including anemia with hemoglobin \<10, leucopenia (WBC\<4k/mcl), thrombocytopenia (Plt\<100K/mcl), abnormal coagulation tests (INR, PTT), or elevation of liver or kidney function tests above the normal values.
3. Patient with active infection, sepsis or pneumonia.
4. Pregnant or nursing women.
5. Unable or unwilling to receive Curcumin-Berberine (Coptis) therapy
6. Known allergy to either curcumin or Berberine (Coptis)

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Primary outcomes:
measure: Percentage of patients reaching clinical response after initiation of therapy.
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of patients who had a clinical remission after initiation of therapy.
timeFrame: 8 weeks
measure: Percentage of patients who had a rapid clinical response after induction of therapy.
timeFrame: 8 weeks
measure: 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).
timeFrame: 8 weeks
measure: Time-to-response defined as number of days to achieve a drop of ≥3 points of the DICS score.
timeFrame: 8 weeks
measure: The percentage of patients in clinical remission at day 7 after induction of therapy.
timeFrame: Within 7 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Gastroenterology department, Sheba Medical Center
name: Adi Lahat-Zok, MD
role: PRINCIPAL_INVESTIGATOR
References: