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

Last updated: December 3, 2023
Sponsor: Dr. Adi Lahat
Overall Status: Active - Recruiting

Phase

2

Condition

Intra-abdominal Infections

Gastrointestinal Diseases And Disorders

Treatment

Placebo

Curcumin-Berberine (coptis)

Clinical Study ID

NCT05596214
7824-20-SMC
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 1. Established diagnosis of previous acute diverticulitis (AD) and on-going abdominalsymptoms comprising a SUDD (left abdominal pain and/or change in bowel habits andbloating) 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

Exclusion

Exclusion Criteria: 1. Patient with non-controlled renal or liver disease, hypertension, cardiovasculardisease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstonedisease, 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 coagulationtests (INR, PTT), or elevation of liver or kidney function tests above the normalvalues. 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)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 14, 2022
Estimated Completion Date:
May 31, 2025

Study 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.

Connect with a study center

  • Sheba Medical Center

    Ramat Gan, 5262000
    Israel

    Active - Recruiting

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