Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06187298
• Other study ID #: LUMHS/UOL-BE/16.12.2023
• Status: Completed
• Start date: August 25, 2020
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 15, 2023
• Est. primary completion date: May 16, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• A combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of care
(Enterophytol® PLUS) alongside standard of care

Locations

Country	Name	City	State
Pakistan	Liaquat University of Medical and Health Sciences	Jamshoro

Sponsors (2)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences	University of Liege

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the overall IBS Severity Index	Reduction in the IBS overall symptoms severity index	At 2 months
Secondary	Change in weekly frequency of stool passage	Treatment effect on patient's weekly stool passage frequency	At 2 months
Secondary	Change in the stool form	Change in the physical appearance of patient's stool	At 2 months
Secondary	Change in the number of IBS standard of care drugs	Treatment effect on patient's need for IBS drugs	At 2 months
Secondary	Number of patients with side effects	Treatment safety and tolerability	At 2 months
Secondary	Number of patients with treatment satisfaction	Treatment satisfaction	At 2 months