ProbGut: Probiotics on the Healthy Gut Microbiota

The ProbGut Study: Effects of Probiotics on the Gut Microbiota of Healthy Children

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Probiotic yogurt drink

Detailed Description

Probiotics are live microorganisms that have been associated with health benefits. However, probiotic effects have not been shown to persist beyond discontinuation of use in adults. The intake of probiotics during the critical window of gut microbiota development in young children, however, may allow for a longer duration of persistence of probiotic bacteria and more stable changes in microbial composition possibly resulting in stable engraftment of the probiotic strains. This study aims is to examine the effect of a 14-day course of a commercially available probiotic yogurt drink on the composition, diversity, and changes in immune biomarkers (e.g. human beta-defensin-2 and calprotectin) of the gut microbiota of healthy children. As well, to assess whether the probiotic strains persists after discontinuation of intake and whether engraftment occurs. By understanding the impact of probiotics on the gut microbiota, we will better understand the mechanism by which probiotics exert their beneficial effects. This may help guide probiotic selection based on the potential short- and long-term effects on the commensal microbiota.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. Mother of participant is able to communicate in English (read, write, speak), as she will be required to provide her personal and medical history.

Exclusion Criteria:

1. Lactose or milk protein intolerance, or strawberry anaphylaxis, or allergies to dried citrus pulp, or any other components of the study product.
2. 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).
3. Children with known or potentially compromised gut integrity (e.g. short gut, Inflammatory Bowel Disease, Celiac, nasogastric, naso-jejunal or gastrostomy tube).
4. Children admitted to a medical or surgical subspecialty unit.
5. Children on antimicrobial therapy within 30 days prior to enrolment.
6. Children on an alternative probiotic within 30 days prior to enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Kids Probiotic Yogurt Drink Group; 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; Food product; yogurt drink containing a multi-strain probiotic.; Other Names: Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Persistence (DOP)	Measure detectable levels of probiotic strains post-treatment	90 days post intervention
Occurrence of Adverse Events	Measure the occurrence and description of adverse events associated with probiotic use	Through study completion, an average of 121 days.

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Mitacs

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): November 30, 2018

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Probiotics; paediatrics; gut microbiota
• Other Study ID Numbers: PROBGUT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No