Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT06187298
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief 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). 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 Timeline

• Study Start: 2020-08-25
• Primary Completion: 2022-05-16
• Study Completion: 2023-12-15
• Study First Submitted: 2023-12-16
• Study First Submitted QC: 2023-12-29
• Status Verified: 2024-01
• Study First Posted: 2024-01-02
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the overall IBS Severity Index	At 2 months	Reduction in the IBS overall symptoms severity index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Liaquat University of Medical and Health Sciences; 🇵🇰 Jāmshoro, Pakistan