IBS - Irritable Bowel SyndromeNCT05990764
Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
A study testing Probiotic, Prebiotic, Polyphenol-rich Extracts and Probiotic, Prebiotic in people with IBS - Irritable Bowel Syndrome, run by AronPharma Sp. z o. o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Probiotic, Prebiotic, Polyphenol-rich Extracts and Probiotic, Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 sitePoland
- Study dates
- 8 May 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed Irritable Bowel Syndrome.
- Women and men, 18-55 years old.
- Signed informed consent.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan
Barbara Khaidakov, PhD, 798 210 651 ext. +48, barbara.khaidakov@aronpharma.pl
Dorota Mańkowska-Wierzbicka, MD, PhD
About this study
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.
Read the 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.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Probiotic, Prebiotic, Polyphenol-rich Extracts, Probiotic, Prebiotic, Placebo
- Keywords
- IBS, Gastrointestinal diseases, Probiotic, Prebiotic, Plant extract, Polyphenol-rich Extracts
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic, Prebiotic, Polyphenol-rich ExtractsDietary supplement
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract
Once a day
Probiotic, PrebioticDietary supplement
probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum)
Once a day
PlaceboOther
placebo
Once a day
| Study group | Role | What they receive |
|---|---|---|
| Probiotic, Prebiotic, Polyphenol-rich Extracts | Experimental | 18 patients with IBS Receives: Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts |
| Probiotic, Prebiotic | Experimental | 18 patients with IBS Receives: Dietary Supplement: Probiotic, Prebiotic |
| Placebo | Placebo comparator | 18 patients with IBS Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 2 months
Stool consistency
Will be assessed using the Bristol Stool Chart
Measured: Baseline, 2 months
Secondary outcomes (5)
Zonulin
Zonulin level in stool samples
Measured: Baseline, 2 months
Short-chain fatty acids
Short-chain fatty acids level in stool samples
Measured: Baseline, 2 months
IL-6
IL-6 level in serum samples
Measured: Baseline, 2 months
IL-8
IL-8 level in serum samples
Measured: Baseline, 2 months
I-FABP
I-FABP level in serum samples
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 May 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990764
- Sponsor's protocol ID
- 03-AP-IBS
- Status last verified
- Nov 2023
- First submitted
- 7 Aug 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05990764
- Acronym / sponsor ID
- 03-AP-IBS
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- IBS, Gastrointestinal diseases, Probiotic, Prebiotic, Plant extract, Polyphenol-rich Extracts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic, Prebiotic, Polyphenol-rich Extracts | Experimental | Dietary Supplement: Probiotic, Prebiotic, Polyphenol-rich Extracts18 patients with IBS |
| Probiotic, Prebiotic | Experimental | Dietary Supplement: Probiotic, Prebiotic18 patients with IBS |
| Placebo | Placebo comparator | Other: Placebo18 patients with IBS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed Irritable Bowel Syndrome.
- Women and men, 18-55 years old.
- Signed informed consent.
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic, Prebiotic, Polyphenol-rich Extractsprobiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract Once a day | Dietary supplement | Probiotic, Prebiotic, Polyphenol-rich Extracts |
| Probiotic, Prebioticprobiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) Once a day | Dietary supplement | Probiotic, Prebiotic |
| Placeboplacebo Once a day | Other | Placebo |
Primary outcome
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
Stool consistency
Time frame: Baseline, 2 months
Will be assessed using the Bristol Stool Chart
5 secondary outcomes
Zonulin
Time frame: Baseline, 2 months
Short-chain fatty acids
Time frame: Baseline, 2 months
IL-6
Time frame: Baseline, 2 months
IL-8
Time frame: Baseline, 2 months
I-FABP
Time frame: Baseline, 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic, Prebiotic, Polyphenol-rich Extracts and Probiotic, Prebiotic in people with IBS - Irritable Bowel Syndrome, run by AronPharma Sp. z o. o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index (time frame: Baseline, 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.