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

NCT ID: NCT05596214

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-14

Study Completion Date

2025-05-31

Brief Summary

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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

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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.

Conditions

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Diverticulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Curcumin-Berberine (coptis)

Intervention Type COMBINATION_PRODUCT

dietary supplement

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Placebo

Interventions

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Curcumin-Berberine (coptis)

dietary supplement

Intervention Type COMBINATION_PRODUCT

Placebo

Placebo

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Adi Lahat

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Adi Lahat

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Adi Lahat-Zok, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology department, Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Adi Lahat-Zok, MD

Role: CONTACT

Phone: +97235307072

Email: [email protected]

Revital Dvir

Role: CONTACT

Phone: +97235307072

Email: [email protected]

Facility Contacts

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Adi Lahat-Zok, MD

Role: primary

Revital Dvir

Role: backup

Other Identifiers

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7824-20-SMC

Identifier Type: -

Identifier Source: org_study_id