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

Diverticulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596214
• Other study ID #: 7824-20-SMC
• Status: Recruiting
• Phase: Phase 2
• Start date: August 14, 2022
• Est. completion date: May 2025

Study information

• Verified date: December 2023
• Source: Sheba Medical Center
• Contact: Adi Lahat-Zok, MD
• Phone: +97235307072
• Email: Adi.Lahat[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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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Related Conditions & MeSH terms

• Diverticulitis

Intervention

Combination Product:
• Curcumin-Berberine (coptis)
dietary supplement
• Placebo
Placebo

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Adi Lahat

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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