Clinical trial NCT06187298: Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Lead sponsor: Liaquat University of Medical & Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Liege
First posted: 2024-01-02
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients enrolled at GP clinics and Pharmacies in Belgium

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in the overall IBS Severity Index
timeFrame: At 2 months
Secondary outcomes:
measure: Change in weekly frequency of stool passage
timeFrame: At 2 months
measure: Change in the stool form
timeFrame: At 2 months
measure: Change in the number of IBS standard of care drugs
timeFrame: At 2 months
measure: Number of patients with side effects
timeFrame: At 2 months
measure: Number of patients with treatment satisfaction
timeFrame: At 2 months
Other outcomes:
Locations:
city: Jāmshoro
country: Pakistan
facility: Liaquat University of Medical and Health Sciences
Study officials:
References: