ProbGut: Probiotics on the Healthy Gut Microbiota

NCT03430726 | Unknown

• 1 other identifier: PROBGUT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In adults, probiotics have been shown to have no effect on the microbial composition and the beneficial effects are only transient. However, the gut microbiota of young children is less stable and more impressionable. The aim of this study is to examine the effects of probiotics on the developing microbiota in early life and to determine whether a young child's microbiota may be less resilient to probiotic-induced changes and possibly resulting in longer lasting probiotic effects compared to adults.

Conditions

Healthy

Keywords

Probiotics; paediatrics; gut microbiota

Outcome Measures

Primary Outcomes (3)

• Composition and Diversity of Gut Microbiota

  Change in microbial community (e.g. alpha and/or beta diversity) post-probiotic

  Baseline, 30 days and 90 days

• Levels of Fecal Biomarkers - beta-defensins-2 (hBD-2)

  Change in levels of beta-defensins-2 (hBD-2)

  Baseline, 21 days, 30 days, and 90 days

• Levels of Fecal Biomarkers - Fecal Calprotectin

  Change in levels of Fecal Calprotectin

  Baseline, 21 days, 30 days, and 90 days

Secondary Outcomes (2)

• Duration of Persistence (DOP)

  90 days post intervention

• Occurrence of Adverse Events

  Through study completion, an average of 121 days.

Study Arms (1)

Healthy Kids Probiotic Yogurt Drink Group

EXPERIMENTAL

Healthy children will be given a commercially available yogurt drink containing a multi-strain probiotic, Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®), daily for 14 days.

Other: Probiotic yogurt drink

Interventions

Probiotic yogurt drink OTHER

Food product; yogurt drink containing a multi-strain probiotic.

Also known as: Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®)

Healthy Kids Probiotic Yogurt Drink Group

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants will be healthy children between 1 to 3 years of age.
• Participants will be considered healthy on entry into the study if they did not have a history of chronic gastrointestinal issues, including chronic or frequent episodes of diarrhea (\>3 bowel movements/day for 3 consecutive days) during the month prior to enrolment.
• Mother of participant is able to communicate in English (read, write, speak), as she will be required to provide her personal and medical history.

You may not qualify if:

• Lactose or milk protein intolerance, or strawberry anaphylaxis, or allergies to dried citrus pulp, or any other components of the study product.
• Immuno-compromised children (e.g. heart or kidney transplant, complex care, sickle cell disease) or those on immunosuppressive agents (e.g. chemotherapy agents, oral prednisone).
• Children with known or potentially compromised gut integrity (e.g. short gut, Inflammatory Bowel Disease, Celiac, nasogastric, naso-jejunal or gastrostomy tube).
• Children admitted to a medical or surgical subspecialty unit.
• Children on antimicrobial therapy within 30 days prior to enrolment.
• Children on an alternative probiotic within 30 days prior to enrolment.

Sponsors & Collaborators

• McMaster University: lead
• Mitacs: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All eligible participants will be assigned to receive the commercially available yogurt drink containing a multi-strain probiotic, Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®), daily for 14 days.

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 13, 2018
• Study Start: March 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: November 30, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)