Combination of Curcumin and Berberine Therapy in the Trea... | NCT05596214

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

NCT05596214

Sponsor

Dr. Adi Lahat

Status

Unknown status

Last Update Posted

Dec 8, 2023Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Diverticulitis

Interventions

Curcumin-Berberine (coptis)
Placebo

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2022Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

May 2025Estimated

First Submitted Date

Sep 18, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2023

Last Update Posted Date

Dec 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Curcumin-Berberine (coptis)	Combination Product	dietary supplement	Curcumin-Berberine (coptis) therapy

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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)

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adi Lahat-Zok, MD	Contact	+97235307072		Adi.Lahat@sheba.health.gov.il
Revital Dvir	Contact	+97235307072		revital.dvir@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Adi Lahat-Zok, MD	Gastroenterology department, Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Ramat Gan		5262000	Israel

ID	Term
D004238	Diverticulitis

ID	Term
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
C000714527	Coptis extract

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.