Effects of a dietary supplement (Eurekol™ based on BIOintestil®) on the intestinal symptoms of patients with irritable bowel syndrome
| ISRCTN | ISRCTN12928913 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12928913 |
| Secondary identifying numbers | EK-01 |
- Submission date
- 09/12/2024
- Registration date
- 11/12/2024
- Last edited
- 10/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Eurekol™ is a food supplement based on BIOintestil®, a mixture of Palmarosa (Cymbopogon martinii) essential oil, titrated in Geraniol, adsorbed on Ginger (Zingiber officinale) vegetable fiber, formulated as a support for the management of irritable bowel syndrome (IBS) symptoms. Eurekol™ has been produced in compliance with current regulatory provisions and duly notified to the Italian Ministry of Health. The BIOintestil® formulation is patented in Europe (EP3097921), and the safety of its components has been widely demonstrated through studies conducted in both laboratory animals and humans. The adsorption onto fiber makes Geraniol poorly absorbable in the small intestine. This allows the active ingredient to reach the colon, where it is released following the degradation of the fiber by resident microorganisms. Geraniol then acts topically, modulating the microbiota, often altered in patients with IBS, and restoring balance. Several studies have been conducted on this very low absorbable Geraniol formulation, demonstrating its efficacy. This trial aims to confirm the effect previously observed in patients with IBS.
Who can participate?
Patients diagnosed with IBS enrolled in private Italian gastroenterology practices
What does the study involve?
Private sites will handle enrolment, and the supplement will be administered to each patient for 30 days (2 tablets/day). The enrolment period will be 8 months, with a total study duration of 9 months. Each Investigator will provide two packages of Eurekol™ to cover the 30-day treatment. Eurekol™, containing BIOintestil® (a mixture of Palmarosa essential oil and Ginger fibre), will support IBS symptom management. Patients will complete the IBS-SSS questionnaire before and after treatment to assess symptoms and quality of life changes.
What are the possible benefits and risks of participating?
Patients will have the opportunity to try an innovative supplement specifically formulated for the management of IBS symptoms, whose effectiveness has already been scientifically demonstrated. Additionally, they will be monitored by a gastroenterologist for the entire duration of the study. Therefore, no undesirable side effects were expected.
Where is the study run from?
Diadema Farmaceutici, Italy
When is the study starting and how long is it expected to run for?
February 2024 to November 2024
Who is funding the study?
Diadema Farmaceutici, Italy
Who is the main contact?
Giammario Piras (Project manager and study coordinator), g.piras@diademafarma.it
Contact information
Public
Via Gaetano Malasoma, 14/16
Pisa
56121
Italy
| Phone | +39 348.8255843 |
|---|---|
| g.piras@diademafarma.it |
Scientific, Principal Investigator
Via Selmi, 3
Bologna
40126
Italy
 ORCID ID |
0000-0002-8525-2981 |
|---|---|
| Phone | +39 0512094147 |
| enzo.spisni@unibo.it |
Study information
| Study design | Interventional multicenter open-label clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other therapist office |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Very low-absorbable Geraniol in treatment of irritable bowel syndrome: a “real-life” open-label study on 1585 patients |
| Study objectives | The primary objective of the study was to confirm the effect of a very low absorbable Geraniol formulation (BIOintestil®) on self-reported symptoms of IBS and the quality of life of affected individuals, in a large sample of patients. The secondary objectives were to confirm the effect of treatment with a very low absorbable Geraniol formulation on the different IBS subtypes. |
| Ethics approval(s) |
Approved 07/02/2024, Independent Ethical Committee for Non-Pharmacological Clinical Investigations - Italian Scientific Society (Via XX Settembre, 30/4, Genova, 16121, Italy; +39 0105454842; a.scudieri@studinonfarmacologici.it), ref: 2024/01 |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome |
| Intervention | This study is an interventional multicentre clinical trial, conducted open-label with the dietary supplement Eurekol™. Eurekol™ is a food supplement based on BIOintestil®, a mixture of Palmarosa (Cymbopogon martinii) essential oil, titrated in Geraniol, adsorbed on Ginger (Zingiber officinale) vegetable fibre, formulated as a support for the management of IBS symptoms. The sites involved in enrolment are private practices and the food supplement will be administered to each patient in the study for 30 days (2 tablets/day). The enrolment period will be 8 months, and the total duration of the study will be 9 months. Each Investigator will assign two packages of Eurekol™ to each enrolled subject, which is sufficient to cover the recommended daily dose (2 tablets/day) for the 30 days of the planned treatment. Every patient will be asked to complete the IBS-SSS (IBS-Severity Scoring System) questionnaire, before and after the treatment period, to assess any changes in symptoms and quality of life. Both the responses to the individual questions and the final scores will be compared. The percentage of responders will then be calculated: a reduction in IBS-SSS score ≥ 50 points is considered a clinically significant improvement. |
| Intervention type | Supplement |
| Primary outcome measure | Changes in the severity of IBS symptoms in the total population measured using the IBS-SSS questionnaire before and after 30 days of treatment |
| Secondary outcome measures | 1. Changes in the severity of IBS symptoms in IBS subtype populations (IBS-C; IBS-D; IBS-M and IBS-U) measured using the IBS-SSS questionnaire before and after 30 days of treatment 2. Changes in bowel function measured using the Bristol Stool Chart before and after 30 days of treatment |
| Overall study start date | 07/02/2024 |
| Completion date | 15/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 1800 |
| Total final enrolment | 1736 |
| Key inclusion criteria | 1. Age between 18 and 65 years 2. Signed informed consent 3. Diagnosis of IBS according to the Rome IV criteria 4. Body weight between 48 kg and 104 kg, with a BMI < 27 |
| Key exclusion criteria | 1. Known or suspected hypersensitivity to Palmarosa essential oil, Ginger or any excipients contained in the dietary supplement used for the treatment 2. Diagnosis of IBD, celiac disease or other severe systemic diseases 3. Severe concomitant diseases that, in the Investigator's opinion, contraindicate the patient's participation in the study 4. Lactose intolerance or confirmed food allergies 5. Use of steroidal anti-inflammatory drugs, antibiotics, or supplements and/or functional foods containing pre-/pro-biotics in the month preceding enrollment 6. Use of experimental drugs in the two months preceding enrollment |
| Date of first enrolment | 15/02/2024 |
| Date of final enrolment | 10/10/2024 |
Locations
Countries of recruitment
- Italy
Study participating centres
Andria
76123
Italy
Sassari
07100
Italy
San Ferdinando di Puglia
76017
Italy
Roma
00179
Italy
Napoli
80131
Italy
Napoli
80131
Italy
Napoli
80147
Italy
Brindisi
72100
Italy
Napoli
80131
Italy
Barletta
76121
Italy
Pomigliano D'arco
80038
Italy
Roma
00148
Italy
Cacciano
82030
Italy
Imola
40026
Italy
Pinerolo
038975
Italy
Pomigliano d'Arco
80038
Italy
Mola di Bari
70042
Italy
Andria
76123
Italy
Ferrara
44124
Italy
Olbia
07026
Italy
Ferrara
44124
Italy
Montecchio Maggiore
36075
Italy
Napoli
80138
Italy
Avellino
83100
Italy
Molfetta
70056
Italy
Oristano
09170
Italy
Mercato San Severino
84085
Italy
Napoli
80121
Italy
Manfredonia
71043
Italy
Oristano
09170
Italy
Pompei
80045
Italy
Sponsor information
Industry
Via Gaetano Malasoma, 14/16
Pisa
56121
Italy
| Phone | +39 0509913750 |
|---|---|
| office@diademafarma.it | |
| Website | https://www.diademafarma.it/it |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 20/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in the journal Nutrients, an international, peer-reviewed, open-access journal of human nutrition published semimonthly online by MDPI. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical restrictions (patient confidentiality). |
Editorial Notes
10/12/2024: Study's existence confirmed by the Independent Ethical Committee for Non-Pharmacological Clinical Investigations - Italian Scientific Society.
