DiverticulitisPhase 2NCT05596214
Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (SUDD)
A Phase 2 study testing Curcumin-Berberine (coptis) in people with Diverticulitis, run by Dr. Adi Lahat at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diverticulitis
- What is being tested?
- Curcumin-Berberine (coptis)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Aug 2022to May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
- 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)
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 5262000
Adi Lahat-Zok, MD, +97235307072, Adi.Lahat@sheba.health.gov.il
Revital Dvir, +97235307072, gastro.research@sheba.health.gov.il
About this study
Official title: Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (AD) Symptomatic Uncomplicated Diverticular Disease (SUDD)
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.
Read more
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.
Read the 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.
- Conditions
- Diverticulitis
- Being tested
- Curcumin-Berberine (coptis), Placebo
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin-Berberine (coptis)Combination product
dietary supplement
PlaceboCombination product
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Combination Product: Curcumin-Berberine (coptis) |
| Placebo | Placebo comparator | 2 capsules of 500 mg placebo before breakfast and 3 capsules of 500mg placebo before dinner. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients reaching clinical response after initiation of therapy.
Clinical response is defined as a drop of ≥3 points of the DICS score.
Measured: 8 weeks
Secondary outcomes (5)
Percentage of patients who had a clinical remission after initiation of therapy.
Clinical remission is defined as DICS score ≤ 5 within 4 weeks.
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start14 Aug 2022
- Primary completionSep 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Adi Lahat
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr. Adi Lahat, Sheba Medical Center
- Investigators
- Adi Lahat-Zok, MD, Principal investigator, Gastroenterology department, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596214
- Sponsor's protocol ID
- 7824-20-SMC
- Status last verified
- Dec 2023
- First submitted
- 18 Sep 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Curcumin and Berberine Therapy in the Treatment of Post Acute Diverticulitis (AD) Symptomatic Uncomplicated Diverticular Disease (SUDD)
- ClinicalTrials.gov ID
- NCT05596214
- Acronym / sponsor ID
- 7824-20-SMC
- Conditions
- Diverticulitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. Adi LahatOther government
- Study start
- 14 Aug 2022 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Curcumin-Berberine (coptis) therapy | Experimental | Combination Product: Curcumin-Berberine (coptis)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). |
| Placebo | Placebo comparator | Combination Product: Placebo2 capsules of 500 mg placebo before breakfast and 3 capsules of 500mg placebo before dinner. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- -
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin-Berberine (coptis)dietary supplement | Combination product | Curcumin-Berberine (coptis) therapy |
| PlaceboPlacebo | Combination product | Placebo |
Primary outcome
Percentage of patients reaching clinical response after initiation of therapy.
Time frame: 8 weeks
Clinical response is defined as a drop of ≥3 points of the DICS score.
5 secondary outcomes
Percentage of patients who had a clinical remission after initiation of therapy.
Time frame: 8 weeks
Percentage of patients who had a rapid clinical response after induction of therapy.
Time frame: 8 weeks
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).
Time frame: 8 weeks
Time-to-response defined as number of days to achieve a drop of ≥3 points of the DICS score.
Time frame: 8 weeks
The percentage of patients in clinical remission at day 7 after induction of therapy.
Time frame: Within 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adi Lahat-Zok, MD principal investigator
Gastroenterology department, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin-Berberine (coptis) in people with Diverticulitis, run by Dr. Adi Lahat at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adi Lahat-Zok, MD (+97235307072, Adi.Lahat@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients reaching clinical response after initiation of therapy. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.