Irritable Bowel Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTA combined supplement of Berberine and Curcumin (Enterophytol® PLUS) alongside standard of care
(Enterophytol® PLUS) alongside standard of care
Sponsors
University of Liege
Liaquat University of Medical & Health Sciences
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the overall IBS Severity Index | At 2 months | Reduction in the IBS overall symptoms severity index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weekly frequency of stool passage | At 2 months | Treatment effect on patient's weekly stool passage frequency |
| Change in the stool form | At 2 months | Change in the physical appearance of patient's stool |
| 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 side effects | At 2 months | Treatment safety and tolerability |
| Number of patients with treatment satisfaction | At 2 months | Treatment satisfaction |
Countries
Pakistan
Outcome results
None listed