Welcome!
We know you might have questions about our research study.
The COMFY Study, sponsored by DSM Nutritional Products AG, is exploring how a product called Humiome® Post LB might help support better gut comfort and bowel habits in healthy adults who experience occasional digestive symptoms.
Here’s what you need to know about participating. This page provides a summary. For full details about your rights, potential risks, and study procedures, please refer to the complete Participant Information and Consent Form.
The following steps are required to proceed:
1.Please click on the video Screen Below to Watch the Introduction to the COMFY Study.
In this video, the purpose of this study, the study design, risks and benefits and what is expected from the participant and the if you decide to participate. After listening to this recording, please read the informed consent and assent forms as well as the Frequently Asked Questions. This video is meant for parents, legal guardians and the child to watch together. Some of the words we use in this video are directed more toward the parents/guardians, but that doesn’t mean the information is also not important to the child.
COMFY STUDY Introduction Video
2. ICF & Assent Consent Forms
Please take your time to read through both the ICF form, as you will be required to sign them at your initial screening visit should you qualify for the study.
Please do not sign them in advance as they must be signed at the visit after the study staff are assured all your questions have been answered.
3. Frequently Asked Questions
What is the Purpose of the COMFY Study?
Gut issues like heartburn, bloating, constipation, and diarrhea are common and can make everyday life uncomfortable. Managing these problems can be difficult, and treatments sometimes have unwanted side effects. This study explores whether a specific postbiotic product, Humiome® Post LB, can help improve gut comfort and support regular bowel movements in healthy adults with self-reported digestive issues. The goal is to learn more about the potential benefits of postbiotics for gut comfort.
Who is conducting the COMFY study?
The study is sponsored by DSM Nutritional Products AG and is being conducted by KGK Science Inc. at their research center in London, Ontario, Canada.
What type of study is this?
This is a randomized, double-blind, placebo-controlled clinical trial.
Here’s what that means:
- Randomized: Participants are assigned by chance to receive either the study product (Humiome® Post LB) or a placebo (a capsule that looks the same as the study product but does not have active ingredients).
- Double-blind: Neither you nor the study staff will know which one you’re taking during the study. This helps keep the results fair and unbiased.
How long will the study last?
If you’re eligible and choose to participate, your involvement will last about 76 days (just under 11 weeks).
This includes:
- A 2-week “run-in” period before you start the study product, where you’ll track your daily habits.
- Then, about 8 weeks of taking the study product once a day and completing short daily check-ins.
The overall COMFY study is expected to run from early 2025 to early 2026, but your personal participation would be for about two and a half months.
ELIGILBILITY
Can I join the COMFY Study?
You may be eligible if you:
- Are 18–75 years old.
- Can provide written informed consent.
- Have a BMI between 18.5 and 29.9 kg/m².
- Have digestive symptoms, like 10–20 bowel movements per week and a stool consistency scale of 5 or 6 (we’ll show you a simple stool chart!).
- Are generally healthy, based on a study doctor’s review.
- Are willing to avoid certain supplements and gut medications during the study.
- Can maintain your usual diet, exercise, and lifestyle during the study.
- (If female and of childbearing age) Have a negative pregnancy test and use approved birth control.
Not sure if you qualify? Don’t worry — the study team will help you during screening!
What does “competitive enrollment” mean?
The study is first-come, first-served. Once 250 people are enrolled, no more spots will be available. Even if you qualify, the study could fill up before you start. If that happens, the team will let you know.
Study Product & How's It Taken
What is Humiome® Post LB?
Humiome® Post LB is a postbiotic — meaning it’s made from beneficial bacteria that have been inactivated (no longer alive) but may still have positive effects on gut health.
It includes two types of inactivated bacteria, Limosilactobacillus fermentum and Lactobacillus delbrueckii subsp. lactis, often grouped together as Lactobacillus LB. These bacteria are well-known and have been safely used in food products for many years.
Humiome® Post LB is recognized as a postbiotic by the International Scientific Association for Probiotics and Prebiotics (ISAPP), and its ingredients are included on safety lists maintained by organizations like the European Food Safety Authority and Health Canada.
How do I take it?
You’ll take one 170 mg capsule each day with a glass of water after your first meal. The capsules will contain either Humiome® Post LB or a placebo.
What if I miss a dose?
If you forget, just take one capsule after your next meal. Don’t take more than two capsules in a single day.
How do I store it?
Keep the capsules at room temperature (15–25°C), away from sunlight, heat, and moisture. They should not be refrigerated. You’ll receive them in sealed blister packs labeled with your study ID.
Do I need to return it?
Yes, you’ll return all unused capsules and packaging at your final visit. This helps the study team confirm how consistently the study product was taken.
PARTICIPATION
What will I need to do if I join the COMFY Study?
If you qualify, your participation will happen in several phases:
- Screening Visit:
We’ll review your health history, current medications, and check basic measurements like height, weight, blood pressure, and heart rate. If needed, a urine pregnancy test will be done. You’ll also receive instructions, diaries, food records, and a stool sample kit. Some parts may happen virtually.
- Run-in Period:
During these two weeks, you’ll track your bowel habits, complete food records, and collect a stool sample. You’ll be asked to keep your usual lifestyle(including diet, level of physical activity, allowed medication/supplements) during this time.
- Baseline Visit:
You’ll bring back your completed diaries and stool sample. We’ll repeat a few measurements, including a urine pregnancy test if needed. If you’re still eligible, you’ll be randomized into a study group. We’ll take more measurements, have you complete some questionnaires, and give you your study product, new diaries and food records with instructions for the next steps.
- Remote Visit 3 (Week 4):
This virtual check-in reviews your diary, food record, and any changes in your health. You’ll also complete a few questionnaires and get new materials for the final stretch.
- End of Study Visit (Week 8):
Your last clinic visit! You’ll return all diaries, food records, the final stool sample, and any unused study product. We’ll take a few final measurements and have you complete some questionnaires. A urine pregnancy test will be done if needed.
What questionnaires and diaries will I complete?
During the study, you’ll fill out:
- Bowel Habits Diary (BHD) & Bristol Stool Scale (BSS): Track daily bowel movements and stool consistency.
- Study Diary: A daily online diary about your bowel habits, study product use, health changes, and any side effects.
- Food Records: A 3-day record of everything you eat, collected during the run-in and before Week 4 and Week 8 visits.
- SF-36 Health Survey: Measures your overall health and well-being.
- Gastrointestinal Symptom Rating Scale (GSRS): Tracks common digestive symptoms.
- Perceived Benefits Questionnaire: Captures how you feel about the study product’s effect. (Completed at final visit).
Will I need to provide samples?
Yes. You’ll provide stool samples at the Baseline and End of Study visits using a kit we’ll give you. These samples are analyzed for gut health and are coded to protect your identity.
If you are a female able to become pregnant, you’ll also provide a urine sample for pregnancy testing at the Screening, Baseline, and End of Study visits
Compensation
Will I be paid for participating?
Yes. If you complete the full study and meet all the requirements, you’ll receive $550. Payment is made after you finish, using a prepaid Mastercard called a Clincard.
What if I leave the study early?
If you start the study (complete Visit 2 and get the study product) but leave early, you’ll still get partial payment based on how many visits you completed.
Will the study cover my regular healthcare costs?
No. The study covers anything related to the study—tests, study product, exams—but you’re still responsible for your usual healthcare and prescriptions outside of the study.
Data & Privacy
How will my privacy be protected?
Your personal information will be kept confidential by the KGK Science team. Health information will be stored securely (locked files and password-protected systems) and only authorized people will have access.
Who will see my study information?
Only the study doctor and team, the sponsor’s staff (like auditors), the Research Ethics Board (REB), and government agencies like Health Canada might review your information. They won’t use your name in any reports.
Will my name be used in study publications?
No. You won’t be identified in any reports or publications.
How long will my information be kept?
Your study data will be securely stored for at least 15 years to comply with Canadian clinical trial regulations.
Will my information or samples be used for other research?
Yes, your de-identified (anonymous) data and samples may be used for future studies without asking you again. While the risk of re-identification is very low, privacy protections are in place.
Safety & Side Effects
How will my safety be checked?
Your health will be closely monitored at each visit and in your study diaries. The study doctor will review any side effects you report and check your vital signs (blood pressure and heart rate).
What side effects could happen?
Possible side effects of the study product include:
- Stomach discomfort
- Vomiting
- Trouble sleeping (insomnia)
- Constipation
- Dehydration
You may not experience any side effects.
Could I have an allergic reaction?
Yes. The study product contains milk derivatives and lactose as well as other non-medicinal ingredients. Additionally, it may contain wheat, barley, or soy. If you have allergies to milk, lactose, or any of the ingredients listed (we will show you the list!) or to wheat, barley, or soy you shouldn’t join the study. Severe allergic reactions are rare but can be serious. Watch for rash, difficulty breathing, swelling, dizziness, or fast heartbeat. If you have a medical emergency related to your participation, seek immediate medical attention or go to the emergency room, and then contact the study staff at our contact information found in this page below.
What should I do if I feel sick or have side effects?
Tell the study team right away. If you have a fever, vomiting, bloody diarrhea, or strong stomach pain, call them immediately.
In an emergency (like a severe allergic reaction), get medical help right away, then contact the study team afterward.
Withdrawl & Ending Participation
Can I leave the study whenever I want?
Yes. Joining the study is voluntary. You can leave at any time without any penalty or effect on your medical care. Please let the study staff know if you decide to leave.
Can the study doctor remove me from the study?
Yes. You might be taken out of the study if you miss visits, don’t follow the study rules, develop a health issue, or get pregnant.
What happens if I leave early?
You’ll need to return all study materials. The study doctor might ask you to complete some final checks. You’ll still receive payment for the visits you completed.
Contact Information
Who do I contact if I have any questions or concerns regarding the study?
You can contact the study staff at KGK Science anytime:
- Phone: 519-438-9374
- Email: clinic@kgkscience.com
- Address: 275 Dundas St, Suite G02, London, ON N6B 3L1
Who do I contact about my rights as a participant?
If you have concerns about your rights or safety, contact Univo Research Ethics Board (REB):
- Phone: (919) 910-7743
- Email: info@univo-group.com
For More information on this Study Please contact the clinic Staff at:
clinic@kgkscience.com
