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OpenTrials
Completed

NCT Number: NCT06187298

Effect of Oral Combined Berberine and Curcumin Pharmacological Therapy on IBS

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liaquat University of Medical and Health Sciences

Jāmshoro, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Dietary Supplement

(Enterophytol® PLUS) alongside standard of care

Primary outcomes

  1. Change in the overall IBS Severity Index

    Time frame: At 2 months

    Reduction in the IBS overall symptoms severity index

Secondary outcomes

  1. Change in weekly frequency of stool passage

    Time frame: At 2 months

    Treatment effect on patient's weekly stool passage frequency

  2. Change in the stool form

    Time frame: At 2 months

    Change in the physical appearance of patient's stool

  3. Change in the number of IBS standard of care drugs

    Time frame: At 2 months

    Treatment effect on patient's need for IBS drugs

  4. Number of patients with side effects

    Time frame: At 2 months

    Treatment safety and tolerability

  5. Number of patients with treatment satisfaction

    Time frame: At 2 months

    Treatment satisfaction

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Liege

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 2, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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