Back to resultsEffects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Primary Purpose
IBS - Irritable Bowel Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Probiotic, Prebiotic, Polyphenol-rich Extracts
Probiotic, Prebiotic
Placebo
Sponsored by
About this trial
This is an interventional other trial for IBS - Irritable Bowel Syndrome focused on measuring IBS, Gastrointestinal diseases, Probiotic, Prebiotic, Plant extract, Polyphenol-rich Extracts
Eligibility 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,
Sites / Locations
- Uniwersytet Medyczny im. Karola Marcinkowskiego w PoznaniuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Probiotic, Prebiotic, Polyphenol-rich Extracts
Probiotic, Prebiotic
Placebo
Arm Description
18 patients with IBS
18 patients with IBS
18 patients with IBS
Outcomes
Primary Outcome Measures
IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index
IBS-QoL measures the impact of the disease on the quality of life of patients with IBS
Stool consistency
Will be assessed using the Bristol Stool Chart
Secondary Outcome Measures
Zonulin
Zonulin level in stool samples
Short-chain fatty acids
Short-chain fatty acids level in stool samples
IL-6
IL-6 level in serum samples
IL-8
IL-8 level in serum samples
I-FABP
I-FABP level in serum samples
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05990764
Brief Title
Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AronPharma Sp. z o. o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
Keywords
IBS, Gastrointestinal diseases, Probiotic, Prebiotic, Plant extract, Polyphenol-rich Extracts
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotic, Prebiotic, Polyphenol-rich Extracts
Arm Type
Experimental
Arm Description
18 patients with IBS
Arm Title
Probiotic, Prebiotic
Arm Type
Experimental
Arm Description
18 patients with IBS
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
18 patients with IBS
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic, Prebiotic, Polyphenol-rich Extracts
Intervention Description
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract
Once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic, Prebiotic
Intervention Description
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum)
Once a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Once a day
Primary Outcome Measure Information:
Title
IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index
Description
IBS-QoL measures the impact of the disease on the quality of life of patients with IBS
Time Frame
Baseline, 2 months
Title
Stool consistency
Description
Will be assessed using the Bristol Stool Chart
Time Frame
Baseline, 2 months
Secondary Outcome Measure Information:
Title
Zonulin
Description
Zonulin level in stool samples
Time Frame
Baseline, 2 months
Title
Short-chain fatty acids
Description
Short-chain fatty acids level in stool samples
Time Frame
Baseline, 2 months
Title
IL-6
Description
IL-6 level in serum samples
Time Frame
Baseline, 2 months
Title
IL-8
Description
IL-8 level in serum samples
Time Frame
Baseline, 2 months
Title
I-FABP
Description
I-FABP level in serum samples
Time Frame
Baseline, 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Facility Information:
Facility Name
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
City
Poznań
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Khaidakov, PhD
Phone
798 210 651
Ext
+48
Email
barbara.khaidakov@aronpharma.pl
First Name & Middle Initial & Last Name & Degree
Dorota Mańkowska-Wierzbicka, MD, PhD
First Name & Middle Initial & Last Name & Degree
Liliana Łykowska-Szuber, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
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