Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS

NCT06187298 | Completed DMC

• 1 other identifier: LUMHS/UOL-BE/16.12.2023
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in the overall IBS Severity Index

  Reduction in the IBS overall symptoms severity index

  At 2 months

Secondary Outcomes (5)

• Change in weekly frequency of stool passage

  At 2 months

• Change in the stool form

  At 2 months

• Change in the number of IBS standard of care drugs

  At 2 months

• Number of patients with side effects

  At 2 months

• Number of patients with treatment satisfaction

  At 2 months

Interventions

A combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of care DIETARY_SUPPLEMENT

(Enterophytol® PLUS) alongside standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients enrolled at GP clinics and Pharmacies in Belgium

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Liege: collaborator

Study Sites (1)

Liaquat University of Medical and Health Sciences

Jāmshoro, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 39421612 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: August 25, 2020
• Primary Completion: May 16, 2022
• Study Completion: December 15, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)