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

Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (AD) Symptomatic Uncomplicated Diverticular Disease (SUDD)

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.

Study Overview

• Status: Recruiting
• Conditions: Diverticulitis
• Intervention / Treatment: Combination product: Curcumin-Berberine (coptis); Combination product: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Adi Lahat-Zok, MD; Phone Number: +97235307072; Email: Adi.Lahat@sheba.health.gov.il
• Study Contact Backup: Name: Revital Dvir; Phone Number: +97235307072; Email: revital.dvir@sheba.health.gov.il

Study Locations

• Israel
  • Ramat Gan, Israel, 5262000
    • Recruiting
    • Sheba Medical Center
    • Contact: Adi Lahat-Zok, MD; Phone Number: +97235307072; Email: Adi.Lahat@sheba.health.gov.il
    • Contact: Revital Dvir; Phone Number: +97235307072; Email: gastro.research@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin-Berberine (coptis) therapy; 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); dietary supplement
Placebo Comparator: Placebo; 2 capsules of 500 mg placebo before breakfast and 3 capsules of 500mg placebo before dinner.	Combination product: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who had a clinical remission after initiation of therapy.	Clinical remission is defined as DICS score ≤ 5 within 4 weeks.	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	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	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	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	Within 7 days

Collaborators and Investigators

• Sponsor: Dr. Adi Lahat
• Investigators: Principal Investigator: Adi Lahat-Zok, MD, Gastroenterology department, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: September 18, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 7824-20-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No