Tolerability and Functional Assessment of a Novel Children's Synbiotic

NCT04534036 | Completed

• 1 other identifier: PDS-08
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Signs and Symptoms; Digestive Signs and Symptoms; Infrequent or Difficult Evacuation

Outcome Measures

Primary Outcomes (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.

  Assessed as the change from baseline and compared to placebo for the continuous variable estimated using a linear mixed model.

  Baseline-Day 84

Secondary Outcomes (8)

• Average increase from baseline of Bristol Stool Form Scale (BSFS) score by ≥ 1 point (stool characterized as an increase to either type 2 or 3 or 4) in the intervention group, compared to the placebo group.

  Baseline-Day 84

• Decrease of ≥ 10% in time spent emptying bowel from beginning to end of bowel movement, compared to baseline.

  Baseline-Day 84

• Changes in subjective assessment of gut tolerability as reported by parents or direct relative guardians, indicated by sustained (longer than 7 days of) abdominal pain, severe bloating, heartburn, acid reflux, or indigestion.

  Baseline-Day 84

• Maintenance or increase of diversity within the PDS-08 treatment group.

  Baseline-Day 84

• Significant increase in QoL measured by the KINDL questionnaire with respect to mean change from baseline score (p<0.05).

  Baseline-Day 84

Study Arms (2)

Multi-Strain Synbiotic (PDS-08)

ACTIVE COMPARATOR

PDS-08 is a rationally defined microbial consortium consisting of 9 strains, with FOS-inulin as prebiotic. Participants will be instructed to take 1 sachet daily for the duration of the trial.

Dietary Supplement: PDS-08

Placebo

PLACEBO COMPARATOR

Placebo sachets for PDS-08 will contain potato or tapioca maltodextrin matched for color and texture. Participants will be instructed to take 1 sachet daily for the duration of the trial.

Other: Placebo

Interventions

PDS-08 DIETARY_SUPPLEMENT

PDS-08 is a novel synbiotic comprised of nine probiotic bacterial strains and FOS-inulin as a prebiotic.

Multi-Strain Synbiotic (PDS-08)

Placebo OTHER

Placebo sachets will contain potato or tapioca maltodextrin.

Placebo

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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).

You may not qualify if:

• Participant is under the care of a parent or direct relative guardian.
• 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.

Sponsors & Collaborators

• Seed Health: lead
• Curebase Inc.: collaborator

Study Sites (1)

Curebase, Inc.

San Francisco, California, 94103-3627, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Constipation; Signs and Symptoms; Signs and Symptoms, Digestive

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Baum, MD

  Encore Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 1, 2020
• Study Start: August 13, 2020
• Primary Completion: January 14, 2022
• Study Completion: February 10, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

US (1)