Tolerability and Functional Assessment of a Novel Children's Synbiotic (NCT04534036) | Clinical Trial Compass
CompletedNot Applicable
Tolerability and Functional Assessment of a Novel Children's Synbiotic
United States64 participantsStarted 2020-08-13
Plain-language summary
Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored.
The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.
Who can participate
Age range
3 Years – 17 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:
* The parent(s) or direct relative guardian(s) of the participant must be willing and able to give informed assent/consent for participation in the study.
* Participant must be in good health as determined from participant's medical history.
* Males \& Females between 3-17 years old.
* Normal weight or overweight (BMI between the age- and sex-specific 5th percentile and 95th percentile).
* Children with constipation (defined as less than 4 bowel movements per week) and/or baseline Bristol Stool Form Scale score of 1 or 2.
* Participant's parent(s) must be willing and able (in the PI's opinion) to comply with all study requirements.
* Children with healthy skin or eczema and/or acne.
* Females of childbearing potential (post-menarche) and/or their parents must make a written and/or verbal statement prior to randomization indicating that they are not pregnant and adhere to a pregnancy prevention method (abstinence or barrier method plus spermicidal foam or oral or implanted contraceptive).
* Consistent use of medications not listed in the exclusion criteria.
* Participant is under the care of a parent or direct relative guardian.
Exclusion Criteria:
* Underweight (BMI\<5th percentile for age) or obese (BMI above the 95th percentile on the Centers for Disease Control and Prevention growth charts).
* Participants are taking, and plan to continue taking, medications (including over the counter (OTC), such as simethicone for gas), home remedies (such as juice…
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.
What they're measuring
1
Percentage of participants who are spontaneous bowel movement responders, defined as having an average of ≥ 4 complete spontaneous bowel movements (CSBMs) per week and an average increase of ≥ 1 CSBM from baseline, by age group: 3-6, 7-12, 13-17 years.