Tolerability and Functional Assessment of a Novel Children's Synbiotic

Completed · Not applicable · Has a placebo group

Conditions studied: Constipation, Signs and Symptoms, Digestive Signs and Symptoms, Infrequent or Difficult Evacuation

In brief

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.

Key facts

Study ID: NCT04534036
Run by: Seed Health
People needed: 64
Starts: 2020-08-13
Expected to finish: 2022-02-10
Last updated by the study team: 2022-10-25

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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 for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
Participants taking laxatives.
Participants using probiotics, antibiotics, or antifungals during the course of the study or within the past 1 month.
Participants receiving administration of any investigational drug within the past 1 month.
Participants who are pregnant, lactating, or planning a pregnancy during the course of the study.
Participants with compromised immunity.
Participants with GI disease (e.g., inflammatory bowel disease, celiac disease, prior intestinal resection, SIBO/small intestinal bacterial growth, irritable bowel syndrome, functional abdominal pain, or lactose intolerance).
Participants are taking medication such as antipsychotics, antidepressants, mood stabilizers, medications for Attention Deficit Hyperactivity Disorder, anti-anxiety medications (Anxiolytics), or related medication.
Participants on medically prescribed diets or supplements other than a standard multivitamin.
Participants with plans to travel outside the USA during the study. Alcohol or drug abuse.
Participants using any oral over the counter or prescription medications for acne or atopic dermatitis.
Participants who have recently tested positive for COVID-19 or who live with adults with an active COVID-19 infection.
Participants are under the care of someone other than a parent or direct relative guardian.

Where it is running

Curebase, Inc. — San Francisco, California, United States

Full record on ClinicalTrials.gov

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