Effects of natural extracts and fibers on quality of life in IBS patients
Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
This study is testing if a mix of natural extracts and fibers can improve the quality of life for people with Irritable Bowel Syndrome (IBS).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AronPharma Sp. z o. o. Industry-sponsored |
| Locations | 1 site (Poznań) |
| Trial ID | NCT05990764 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of a combination of polyphenol-rich extracts, prebiotics, and hydrolyzed fiber on the quality of life of patients suffering from Irritable Bowel Syndrome (IBS). It will be a double-blind, randomized, placebo-controlled trial involving 48 participants aged 18-55 years. Over a period of two months, patients will be divided into three groups: one receiving probiotics and prebiotics, another receiving probiotics, prebiotics, and fruit extracts, and a third receiving a placebo. The study will assess IBS symptoms and measure inflammatory markers and intestinal function through questionnaires and biological samples.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-55 who have been diagnosed with Irritable Bowel Syndrome.
Not a fit: Patients with severe gastrointestinal diseases, autoimmune disorders, or those currently taking certain supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients with IBS by reducing their symptoms.
How similar studies have performed: Other studies have shown promising results with similar approaches using probiotics and prebiotics for IBS, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed Irritable Bowel Syndrome. * Women and men, 18-55 years old. * Signed informed consent. Exclusion Criteria: * Intake of supplements containing plant extracts, polyphenols or anthocyanins, and supplements containing fiber, probiotics and prebiotics. * Participation in another clinical trial. * Inability to swallow an oral study drug/placebo. * Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study. * Women who are pregnant, planning to become pregnant during the study, or breastfeeding,
Where this trial is running
Poznań
- Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu — Poznań, Poland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.