We would like to invite you to take part in our research study. Before you decide whether to participate or not, we would like you to understand why the research is being done and what it will involve.
Please go through this information and don’t hesitate to email us info@ingredients4life.co.uk or call us on +44 7948 352008] to ask any questions you may have. You may talk to others about the study if you wish.
Part 1 tells you the purpose of this study and what will happen to you if you take part.
Part 2 gives you more detailed information about the conduct of the study.
Please take time to decide whether you want to take part in the study.
1. What is the purpose of the study?
The purpose of our study is to investigate if a gut health supplement containing PoZibio®, can improve digestive wellness in adults aged 18-65 with mild to moderate gastrointestinal discomfort. We aim to determine if regular consumption of this supplement can reduce common digestive issues such as bloating, abdominal pain, and irregular bowel movements. By comparing different dosages of PoZibio®, we hope to identify the optimal amount that leads to better gut health, potentially enhancing overall well-being and daily functioning.
2. Why have I been chosen?
You have been chosen to participate in this study because you are an adult aged 18-65 who experiences mild to moderate digestive symptoms such as bloating, abdominal pain, irregular bowel movements, or other related issues with or without diagnosed gastrointestinal disease. Our study aims to include a diverse group of participants (about 160) who represent the general population experiencing common digestive concerns. By participating, you will help us better understand how this supplement containing PoZibio® may improve gut health and overall well-being.
3. Do I have to take part?
Participation in this study is completely voluntary. It is entirely up to you to decide whether you would like to join the research. We have provided this information to help you make an informed choice. If you are interested in participating, you will find a consent form available on the study app after downloading and signing up. You can indicate your decision by selecting ‘Yes’ or ‘No.’ Additionally, there will be a section for you to download the consent form for your records. Please remember that even if you agree to participate now, you are free to change your mind and withdraw from the study at any time without needing to provide a reason. Your comfort and willingness to participate are our top priorities.
4. What will happen to me if I agree to take part?
If you agree to participate in the study, you will be randomly placed in one of three groups. You will be asked to either take one capsule of a nutritional supplement (PoZibio®- heat-killed Lactobacillus paracasei D3-5) – at a dosage of 100mg or 340mg daily – or a placebo (Sunfiber -Partially Hydrolyzed Guar Gum), twice daily for 8 weeks. You will need to complete a series of questionnaires to assess your digestive symptoms and overall well-being once every two weeks, which will take about 10 mins to complete. The Gastrointestinal Symptom Rating Scale (GSRS) will be used to gather information about various digestive issues, including abdominal pain, heartburn, acid reflux, nausea, bloating, and bowel movement regularity. Each question will ask you to indicate the level of discomfort you may have experienced over the past week, ranging from “no discomfort at all” to “very severe discomfort”. This data will help researchers determine the effectiveness of PoZibio® in improving gut health and may contribute valuable insights into managing common digestive concerns. Participants’ responses will be collected through a mobile app called Ingredients for Life™ designed for this study, ensuring a convenient and streamlined process.
NB: Please continue with any prescribed medication (e.g. Gastric ulcer medication) that you might be taking.
5. Will there be any reward for taking part?
As a thank you for participating in the study, we have guaranteed rewards including a £20 gift card for staying with the trial until the end. Additionally, we have more engagement-based rewards to earn. At the end of the study (week 8), if you have used the app at least 90% of the time i.e. daily clicking the tabs on the app to confirm supplement intake and answering the health questionnaires every 2 weeks, you will receive a 30% discount off all elénzia products, and a chance to be 1 of 10 lucky winners of a £100 One4all gift card to shop at multiple stores. All rewards will be sent after the study. If you encounter any problems with the app, our support team is available to assist you.
6. What are the possible disadvantages and risks of taking part?
Participating in the study will require about 10 minutes of your time once every two weeks to answer questions through the mobile app. Also, some participants might find it challenging or frustrating to consistently report their symptoms, especially during periods of discomfort.
The supplement containing PoZibio® is generally considered safe. However, as with any dietary supplement, there is a small risk of unexpected reactions. These may include:
Mild digestive discomfort
Temporary increase in gas or bloating
Changes in bowel movements
In rare cases, some individuals might experience mild allergic reactions. If you experience any concerning symptoms or side effects, please contact the research team immediately. Contact details can be found below:
Email Address: info@ingredients4life.co.uk
Tel: +44 7948 352008
It’s important to note that if at any point you feel overwhelmed by the study requirements, you can take a break and return to the app the next day to complete the previous day’s questions. Your well-being is our priority, and we are committed to addressing any issues that may arise promptly.
Remember, you can withdraw from the study at any time without providing a reason if you feel it’s not suitable for you.
7. What are the possible benefits of taking part?
By participating in this study, you will help researchers understand gut health and potentially improve treatments for mild to moderate gastrointestinal issues. While you may or may not experience direct benefits from taking part, the information we gather could contribute to advancements in healthcare that could benefit future approaches to managing digestive wellness through postbiotic supplements like PoZibio®.
8. What are the side effects of the treatment?
PoZibio is generally well-tolerated, with most users experiencing no significant side effects. Mild reactions, such as temporary stomach upset, bloating, or rare allergic responses like skin rashes, may occur but are typically short-lived. Some users might also notice mild symptoms like increased thirst or fatigue as their body adjusts to the supplement. PoZibio is considered safe and can be used alongside other medications. If you are concerned that you might need treatment, please contact your usual healthcare provider or appropriate service and then notify us at the earliest opportunity. Following the recommended dosage is important to minimise risks, and the supplement has a strong safety profile based on extensive studies and widespread use. It is currently sold in the USA in the gummy and capsule form at the dosage level that has been recommended.
9. What happens when the research study stops?
When the study period ends, we will collect all the information gathered through the app and analyse it thoroughly. Our research team will carefully examine the data to determine if PoZibio® has been effective in improving digestive wellness and reducing gastrointestinal discomfort in participants. After completing our analysis, we will let you know the group you were placed and share both individual and overall findings of the study with all participants. This will provide you with insights into how you may or may not have benefited from the supplement. We will also compare the effectiveness of different dosages to identify the optimal amount of PoZibio® for improving gut health. All personal information will remain confidential, and only anonymized, group-level results will be reported in any publications or presentations resulting from this study. The findings may contribute to future developments in managing mild to moderate gastrointestinal issues and improving overall gut health.
10. What if there is a problem?
If you encounter any issues or have concerns during the study, we are available to assist you. Any complaints regarding your experience or potential discomfort will be taken seriously and addressed promptly. You can report any unusual digestive symptoms or reactions through the study app or by contacting our support team directly. We are committed to ensuring your well-being and will take appropriate steps to resolve any reported concerns. Your feedback is essential, and we strive to maintain a positive experience for all participants. Detailed information on how to report concerns and the resolution process can be found in Part 2 of this document.
11. Will my taking part in the research project be kept confidential?
Yes, your participation in the research project will be kept completely confidential. We are committed to following strict ethical and legal guidelines to ensure that all your personal information and study data are handled with the utmost care and privacy. Our research team will protect your data through anonymization and secure data management practices. Only authorised research personnel will have access to your information, and any reports or publications will use aggregated, anonymous data. For more detailed information about how we protect your personal data, please refer to Part 2 of this document. Your trust is paramount, and we take confidentiality extremely seriously throughout the study.
12. Contact for further information
If you would like any further information about this study, please contact:
Name: Alexander Pilawski
Designation: Lead Scientist
Department: elénzia Medical Nutrition
Email Address: info@ingredients4life.co.uk
Tel: +44 7948 352008
If the information in Part 1 has interested you and you are considering participation, please continue to read the additional information in Part 2 before making any decision.
13. What if new information becomes available?
If new information emerges during the study that could affect our understanding of PoZibio® or its impact on digestive wellness, our research team will promptly inform you. We will explain the significance of this new information and discuss any potential implications for your participation in the study. This new information won’t affect your place in the study. However, if you feel uncomfortable continuing based on this new information, you’re free to withdraw at any time without any negative consequences. If you choose to continue participating after learning about the new information, we may ask you to sign an updated consent form. Your well-being is our top priority, and we’re committed to keeping you fully informed throughout the study.
14. What will happen if you don’t want to carry on with the research?
You have the right to withdraw from the trial at any point in time and all your information will be destroyed within 28 days of the request.
15. What if there is a problem?
If you have a concern about any aspect of this study, you should speak to the research team who will do their best to answer your questions.
Name: Alexander Pilawski
Designation: Lead Scientist
Department: elénzia Medical Nutrition
Email Address: info@ingredients4life.co.uk
Tel: +44 7948 352008
Harm
While we prioritize participant safety, if you are harmed due to our negligence during the study, you may have grounds for legal action. PoZibio® is generally safe but, like all supplements, carries a small risk of unexpected reactions. Contact us immediately with any concerns about your well-being. We’re committed to promptly addressing any issues that arise.
Compensation
In the event of you developing an adverse reaction, side effect or complication because of your participation in the study, elénzia MEDICAL has a responsibility to ensure the adverse event is managed properly and resolved satisfactorily. If required agreed costs of medical treatment will be provided and you will be appropriately compensated for any adverse reaction, side effect or complication which is a direct result of your participation in this study. In this unlikely event, compensation will be paid on a “no-fault basis”.
16. Will taking part in this study be kept confidential?
All information which is collected about you during the research will be kept strictly confidential. Any information about you which leaves elénzia MEDICAL will have your name and address removed so that you cannot be recognised from it. Once the study is complete all personal information will be kept for a maximum of 180 days.
Our procedures for handling, processing, storage and destruction of data are compliant with the Data Protection Act 2018 and GDPR.
17. What will happen to the results of the research study?
When the study has finished, we will present our findings to pharmacists and other healthcare providers. We would also like to put a summary on our elénzia MEDICAL website so that you will be able to read about our results too. This will be available at the end of the study, in June 2025 (https://medical.elenzia.com). All results published will be anonymised and not contain any information regarding your identity.
18. Who is organising and funding the research?
Researchers at elénzia MEDICAL oversee the research and it is fully funded by elénzia MEDICAL. elénzia MEDICAL is dedicated to improving health through scientifically proven, natural solutions. Partnering with leading experts, we aim to alleviate common digestive symptoms, improve overall well-being, and make a real difference in people’s daily lives.
19. Who has reviewed the study?
Before any research is allowed to go ahead, if required, it has been checked by a group of people to ensure that the research is fair. This study has been checked by a group of people called the Reading Independent Ethics Committee and given a favourable ethical opinion for conduct under elénzia Medical.
20. How can we find out more about research?
Contact us for more information at info@ingredients4life.co.uk
If you decide to take part in this study, you will be required to give your consent on the study App and you will be able to download the signed consent form from the app to keep.
Thank you for taking the time to read this information sheet.