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

Primary Purpose

Diverticulitis

Status

Recruiting

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Curcumin-Berberine (coptis)

Placebo

About this trial

This is an interventional treatment trial for Diverticulitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
-

Exclusion Criteria:

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)
-

Sites / Locations

Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin-Berberine (coptis) therapy

Placebo

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Percentage of patients reaching clinical response after initiation of therapy.

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

Secondary Outcome Measures

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

Clinical remission is defined as DICS score ≤ 5 within 4 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

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).

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

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

Full Information

NCT ID

NCT05596214

First Posted

September 18, 2022

Last Updated

October 26, 2022

Sponsor

Dr. Adi Lahat

1. Study Identification

Unique Protocol Identification Number

NCT05596214

Brief Title

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

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 14, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dr. Adi Lahat

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diverticulitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Curcumin-Berberine (coptis) therapy

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

Curcumin-Berberine (coptis)

Intervention Description

dietary supplement

Intervention Type

Combination Product

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Percentage of patients reaching clinical response after initiation of therapy.

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Description

Clinical remission is defined as DICS score ≤ 5 within 4 weeks.

Time Frame

8 weeks

Title

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

Description

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

Time Frame

8 weeks

Title

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).

Time Frame

8 weeks

Title

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

Time Frame

8 weeks

Title

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

Time Frame

Within 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 - Exclusion Criteria: 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) -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adi Lahat-Zok, MD

Phone

+97235307072

Adi.Lahat@sheba.health.gov.il

Facility Information:

Facility Name

Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

5262000

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adi Lahat-Zok, MD

Phone

+97235307072

Adi.Lahat@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Revital Dvir

Phone

+97235307072

gastro.research@sheba.health.gov.il

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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