Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (SUDD)

NCT05596214 | Unknown Phase 2

• 1 other identifier: 7824-20-SMC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients reaching clinical response after initiation of therapy.

  Clinical response is defined as a drop of ≥3 points of the DICS score.

  8 weeks

Secondary Outcomes (5)

• Percentage of patients who had a clinical remission after initiation of therapy.

  8 weeks

• Percentage of patients who had a rapid clinical response after induction of therapy.

  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).

  8 weeks

• Time-to-response defined as number of days to achieve a drop of ≥3 points of the DICS score.

  8 weeks

• The percentage of patients in clinical remission at day 7 after induction of therapy.

  Within 7 days

Study Arms (2)

Curcumin-Berberine (coptis) therapy

EXPERIMENTAL

Cur-Berberine (Coptis) treatment will consist: 2 capsules of 500 mg Berberine (Coptis) before breakfast (a total of 1.0gr Berberine) and 3 capsules of 500mg curcumin before dinner (a total of 1.5gr curcumin).

Combination Product: Curcumin-Berberine (coptis)

Placebo

PLACEBO COMPARATOR

2 capsules of 500 mg placebo before breakfast and 3 capsules of 500mg placebo before dinner.

Combination Product: Placebo

Interventions

Curcumin-Berberine (coptis) COMBINATION_PRODUCT

dietary supplement

Curcumin-Berberine (coptis) therapy

Placebo COMBINATION_PRODUCT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Having an active SUDD defined by Diverticular Clinical Score (DICS) score ≥10.
• Age 18-80 years.
• Able and willing to give written consent

You may not qualify if:

• Patient with non-controlled renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, uncontrolled migraines or neurological disorders
• 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.
• Patient with active infection, sepsis or pneumonia.
• Pregnant or nursing women.
• Unable or unwilling to receive Curcumin-Berberine (Coptis) therapy
• Known allergy to either curcumin or Berberine (Coptis)

Sponsors & Collaborators

• Dr. Adi Lahat: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262000, Israel

RECRUITING

MeSH Terms

Conditions

Diverticulitis

Interventions

Coptis extract

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Adi Lahat-Zok, MD

  Gastroenterology department, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Lahat-Zok, MD

CONTACT

+97235307072; Adi.Lahat@sheba.health.gov.il

Revital Dvir

CONTACT

+97235307072; revital.dvir@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: October 27, 2022
• Study Start: August 14, 2022
• Primary Completion: September 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)