Combining Curcumin and Berberine to Treat Post Acute Diverticulitis

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

This study is testing if a mix of curcumin and berberine can help people who have had diverticulitis feel better and improve their gut health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sheba Medical Center (Government)
• Locations: 1 site (Ramat Gan)
• Trial ID: NCT05596214 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of a combination therapy using curcumin and berberine for patients suffering from post-acute diverticulitis. The approach involves a two-stage process, starting with an open-label exploratory study of 10 patients to assess clinical response. If a sufficient response is observed, a randomized placebo-controlled study will follow. The goal is to explore the dual anti-inflammatory effects and microbiome modulation of this herbal treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of previous acute diverticulitis and ongoing symptoms classified as SUDD.

Not a fit: Patients with uncontrolled chronic diseases or significant laboratory abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel, effective option for patients with post-acute diverticulitis, potentially improving their quality of life.

How similar studies have performed: While the combination of curcumin and berberine has been studied separately, this specific integrative approach in treating post-acute diverticulitis is novel and has not been extensively tested.

Eligibility criteria

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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Where this trial is running

Ramat Gan

• Sheba Medical Center — Ramat Gan, Israel (Recruiting)

Study contacts

• Principal investigator: Adi Lahat-Zok, MD — Gastroenterology department, Sheba Medical Center
• Study coordinator: Adi Lahat-Zok, MD

Conditions Diverticulitis