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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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ClinicalTrials.gov Identifier: NCT05990764
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
AronPharma Sp. z o. o.

Study Description
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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
IBS - Irritable Bowel Syndrome Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts Dietary Supplement: Probiotic, Prebiotic Other: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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)
Actual Study Start Date : May 8, 2023
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index [ Time Frame: Baseline, 2 months ]
    IBS-QoL measures the impact of the disease on the quality of life of patients with IBS

  2. Stool consistency [ Time Frame: Baseline, 2 months ]
    Will be assessed using the Bristol Stool Chart


Secondary Outcome Measures :
  1. Zonulin [ Time Frame: Baseline, 2 months ]
    Zonulin level in stool samples

  2. Short-chain fatty acids [ Time Frame: Baseline, 2 months ]
    Short-chain fatty acids level in stool samples

  3. IL-6 [ Time Frame: Baseline, 2 months ]
    IL-6 level in serum samples

  4. IL-8 [ Time Frame: Baseline, 2 months ]
    IL-8 level in serum samples

  5. I-FABP [ Time Frame: Baseline, 2 months ]
    I-FABP level in serum samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05990764


Locations
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Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Recruiting
Poznań, Poland
Contact: Barbara Khaidakov, PhD    798 210 651 ext +48    barbara.khaidakov@aronpharma.pl   
Principal Investigator: Dorota Mańkowska-Wierzbicka, MD, PhD         
Sub-Investigator: Liliana Łykowska-Szuber, MD, PhD         
Sponsors and Collaborators
AronPharma Sp. z o. o.
More Information
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Responsible Party: AronPharma Sp. z o. o.
ClinicalTrials.gov Identifier: NCT05990764    
Other Study ID Numbers: 03-AP-IBS
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AronPharma Sp. z o. o.:
IBS
Gastrointestinal diseases
Probiotic
 Prebiotic
Plant extract
Polyphenol-rich Extracts
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases