Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Study Details
Study Description
Brief Summary
The aim of the study is to demonstrate a beneficial effect in reducing symptoms that negatively affect the quality of life of IBS patients, and to demonstrate a positive effect on inflammatory and intestinal function markers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The double-blind, randomized, placebo-controlled study will be conducted on 48 patients (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of inflammation and intestinal barrier permeability , will be determined in blood and stool samples collected from patients.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Probiotic, Prebiotic, Polyphenol-rich Extracts 18 patients with IBS |
Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract
Once a day
|
| Experimental: Probiotic, Prebiotic 18 patients with IBS |
Dietary Supplement: Probiotic, Prebiotic
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum)
Once a day
|
| Placebo Comparator: Placebo 18 patients with IBS |
Other: Placebo
placebo
Once a day
|
Outcome Measures
Primary Outcome Measures
- IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index [Baseline, 2 months]
IBS-QoL measures the impact of the disease on the quality of life of patients with IBS
- Stool consistency [Baseline, 2 months]
Will be assessed using the Bristol Stool Chart
Secondary Outcome Measures
- Zonulin [Baseline, 2 months]
Zonulin level in stool samples
- Short-chain fatty acids [Baseline, 2 months]
Short-chain fatty acids level in stool samples
- IL-6 [Baseline, 2 months]
IL-6 level in serum samples
- IL-8 [Baseline, 2 months]
IL-8 level in serum samples
- I-FABP [Baseline, 2 months]
I-FABP level in serum samples
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed Irritable Bowel Syndrome.
-
Women and men, 18-5 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.
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Inability to swallow an oral study drug/placebo.
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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,
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu | Poznań | Poland |
Sponsors and Collaborators
- AronPharma Sp. z o. o.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 03-AP-IBS