Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function (NCT06094153) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function
Singapore108 participantsStarted 2023-10-04
Plain-language summary
Human Milk Oligosaccharides (HMOs) are the third most abundant class of nutrients in human milk. Studies investigating the effects of dietary HMOs in infants have shown various health and developmental benefits such as the development of the early gut microbiome (by favouring colonisation of beneficial Bifidobacterium, Lactobacillus, and Bacteroides), the development of the immune system, general infant growth, protection against infectious diseases and allergies, and stimulation of cognitive development. Only a limited number of studies have been conducted in adults, showing intake of HMOs stimulates the growth of gut Bifidobacterium in healthy adults.
Who can participate
Age range
40 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 40 and ≤ 55 years
* Male/female
* Total score of \>2 on the Gastrointestinal Symptom Rating Scale (GSRS)
* Body Mass Index 18-30 kg/m2
* Stable body weight (± 5%) for at least 6 months
* Stable lifestyle and dietary habits within the 4 weeks prior and during study period
* Owns device (computer, smartphone, tablet) with access to the internet
* Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
* Sufficient vision and hearing to complete study procedures
* Willing and able to participate, follow the study procedures and to give written informed consent
Exclusion Criteria:
* History (\< 6 months prior to the study) or presence of severe gastrointestinal, metabolic, immunological, psychiatric disorder, or major surgery
* Current or past (\< 4 weeks) use of prescription, over-the-counter, or traditional medication, or dietary supplements with a relevant impact on GI system or on visceral motility
* Having received antibiotic treatment \< 4 weeks prior to study
* Alcohol intake \>1 units/day
* Currently pregnant or pregnancy in past 6 months
* Use of pro/prebiotics \< 4 weeks prior to study start
* Fully vegetarian/vegan diet \< 4 weeks prior to study start
* High habitual vegetable and fruit intake (\> 2 servings of fruits and \>2 servings of vegetables per day) \< 4 weeks prior to study start
* Lactose intolerance
* Maltodextrin allergy
* Members of the research team or their…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.