Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: A combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of care

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 Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Pakistan
  • Jāmshoro, Pakistan
    • Liaquat University of Medical and Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients enrolled at GP clinics and Pharmacies in Belgium

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the overall IBS Severity Index	Reduction in the IBS overall symptoms severity index	At 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weekly frequency of stool passage	Treatment effect on patient's weekly stool passage frequency	At 2 months
Change in the stool form	Change in the physical appearance of patient's stool	At 2 months
Change in the number of IBS standard of care drugs	Treatment effect on patient's need for IBS drugs	At 2 months
Number of patients with side effects	Treatment safety and tolerability	At 2 months
Number of patients with treatment satisfaction	Treatment satisfaction	At 2 months

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: December 16, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: LUMHS/UOL-BE/16.12.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No