Irritable Bowel SyndromeNCT06187298
Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS
An observational study of Irritable Bowel Syndrome, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial summary
Irritable bowel syndrome (IBS) is a prevalent, chronic functional gastrointestinal (GI) disorder, characterized by recurrent abdominal discomfort (pain) associated with altered bowel movements. IBS has a considerable negative impact on people's quality of life (QoL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 146 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Aug 2020to 15 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients enrolled at GP clinics and Pharmacies in Belgium
Who may be able to join
- Self-completion of simplified form of the Rome IV IBS diagnostic criteria
- Had IBS symptoms that appeared before the age of 50
- Used Enterophytol® PLUS as complementary therapy as two tablets a day for 2-months
Who cannot join
- Those with involuntary weight loss
- Family history of chronic inflammatory bowel disease, colorectal cancer, celiac disease, rectal discharge, nocturnal symptoms, fever, and abnormalities on clinical examination (abdominal mass, signs of anaemia).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Adjuvant Synergistic Therapeutic Effect of Oral Berberine and Curcumin Alleviates Symptoms of Irritable Bowel Syndrome: Results From a Real-life Setting Clinical Intervention Study
Irritable bowel syndrome (IBS) is a prevalent, chronic functional gastrointestinal (GI) disorder, characterized by recurrent abdominal discomfort (pain) associated with altered bowel movements. IBS has a considerable negative impact on people's quality of life (QoL). There is currently no specific treatment available for IBS; most of the therapeutic management is symptomatic. Reported evidence suggest that BBR and CUR can alleviate symptoms of IBS through their multiple pharmacological effects including preventing stress-induced intestinal inflammation and visceral hypersensitivity, reducing bowel motility, and regulating intestinal permeability, gut microme and gut-brain axis.
Read the detailed description
Aim of the study:
The present clinical study aimed to assess the synergestic therapeutic effect of a combined supplement of standardised extract of BBR and CUR (Enterophytol® PLUS, 200 mg BBR, 49 mg CUR) in the management of IBS.
Method : This was an in real-life setting pragmatic, observational, retrospective, non-controlled and non-randomized clinical trial involving 146 patients with IBS, enrolled in General Practitioner clinics and Pharmacies in Belgium from Aug 2020 to May 2022. The supplement was used as two tablets daily for 2-months, alongside routine IBS care.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- A combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of care
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of careDietary supplement
(Enterophytol® PLUS) alongside standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the overall IBS Severity Index
Reduction in the IBS overall symptoms severity index
Measured: At 2 months
Secondary outcomes (5)
Change in weekly frequency of stool passage
Treatment effect on patient's weekly stool passage frequency
Measured: At 2 months
Change in the stool form
Change in the physical appearance of patient's stool
Measured: At 2 months
Change in the number of IBS standard of care drugs
Treatment effect on patient's need for IBS drugs
Measured: At 2 months
Number of patients with side effects
Treatment safety and tolerability
Measured: At 2 months
Number of patients with treatment satisfaction
Treatment satisfaction
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start25 Aug 2020
- Primary completion16 May 2022
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187298
- Sponsor's protocol ID
- LUMHS/UOL-BE/16.12.2023
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michel P H, Ahn SA, Rousseau MF, Seidel L, Albert A, Janssens I, Dierckxsens Y, Khan A. Potential synergistic antihyperglycemic effects of co-supplemental Amla and Olive extracts in hyperlipidemic adults with prediabetes and type 2 diabetes: results from a real-life clinical study. Front Nutr. 2024 Oct 3;11:1462292. doi: 10.3389/fnut.2024.1462292. eCollection 2024.
PubMed 39421612
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjuvant Synergistic Therapeutic Effect of Oral Berberine and Curcumin Alleviates Symptoms of Irritable Bowel Syndrome: Results From a Real-life Setting Clinical Intervention Study
- ClinicalTrials.gov ID
- NCT06187298
- Acronym / sponsor ID
- LUMHS/UOL-BE/16.12.2023
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 2 Jan 2024 (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.
Irritable bowel syndrome (IBS) is a prevalent, chronic functional gastrointestinal (GI) disorder, characterized by recurrent abdominal discomfort (pain) associated with altered bowel movements. IBS has a considerable negative impact on people's quality of life (QoL). There is currently no specific treatment available for IBS; most of the therapeutic management is symptomatic. Reported evidence suggest that BBR and CUR can alleviate symptoms of IBS through their multiple pharmacological effects including preventing stress-induced intestinal inflammation and visceral hypersensitivity, reducing bowel motility, and regulating intestinal permeability, gut microme and gut-brain axis.
Detailed description
Aim of the study:
The present clinical study aimed to assess the synergestic therapeutic effect of a combined supplement of standardised extract of BBR and CUR (Enterophytol® PLUS, 200 mg BBR, 49 mg CUR) in the management of IBS.
Method : This was an in real-life setting pragmatic, observational, retrospective, non-controlled and non-randomized clinical trial involving 146 patients with IBS, enrolled in General Practitioner clinics and Pharmacies in Belgium from Aug 2020 to May 2022. The supplement was used as two tablets daily for 2-months, alongside routine IBS care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled at GP clinics and Pharmacies in Belgium
Key inclusion criteria (3 listed)
- Self-completion of simplified form of the Rome IV IBS diagnostic criteria
- Had IBS symptoms that appeared before the age of 50
- Used Enterophytol® PLUS as complementary therapy as two tablets a day for 2-months
Key exclusion criteria (2 listed)
- Those with involuntary weight loss
- Family history of chronic inflammatory bowel disease, colorectal cancer, celiac disease, rectal discharge, nocturnal symptoms, fever, and abnormalities on clinical examination (abdominal mass, signs of anaemia).
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 |
|---|---|---|
| A combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of care(Enterophytol® PLUS) alongside standard of care | Dietary supplement | – |
Primary outcome
Change in the overall IBS Severity Index
Time frame: At 2 months
Reduction in the IBS overall symptoms severity index
5 secondary outcomes
Change in weekly frequency of stool passage
Time frame: At 2 months
Change in the stool form
Time frame: At 2 months
Change in the number of IBS standard of care drugs
Time frame: At 2 months
Number of patients with side effects
Time frame: At 2 months
Number of patients with treatment satisfaction
Time frame: At 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 39421612Michel P H, Ahn SA, Rousseau MF, Seidel L, Albert A, Janssens I, Dierckxsens Y, Khan A. Potential synergistic antihyperglycemic effects of co-supplemental Amla and Olive extracts in hyperlipidemic adults with prediabetes and type 2 diabetes: results from a real-life clinical study. Front Nutr. 2024 Oct 3;11:1462292. doi: 10.3389/fnut.2024.1462292. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Jan 2024. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the overall IBS Severity Index (time frame: At 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06187298, which also lists 1 linked publication.
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 29 Jan 2024.