HealthyNCT03430726
ProbGut: Probiotics on the Healthy Gut Microbiota
A study testing Probiotic yogurt drink in people with Healthy, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic yogurt drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Probiotic yogurt drink
- Keywords
- Probiotics; paediatrics; gut microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic yogurt drinkOther
Also called Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®)
Food product; yogurt drink containing a multi-strain probiotic.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Probiotic yogurt drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition and Diversity of Gut Microbiota
Change in microbial community (e.g. alpha and/or beta diversity) post-probiotic
Measured: Baseline, 30 days and 90 days
Levels of Fecal Biomarkers - beta-defensins-2 (hBD-2)
Change in levels of beta-defensins-2 (hBD-2)
Measured: Baseline, 21 days, 30 days, and 90 days
Levels of Fecal Biomarkers - Fecal Calprotectin
Change in levels of Fecal Calprotectin
Measured: Baseline, 21 days, 30 days, and 90 days
Secondary outcomes (2)
Duration of Persistence (DOP)
Measure detectable levels of probiotic strains post-treatment
Measured: 90 days post intervention
Occurrence of Adverse Events
Measure the occurrence and description of adverse events associated with probiotic use
Measured: Through study completion, an average of 121 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs
- Responsible party
- Principal investigator, Kim Chau, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430726
- Sponsor's protocol ID
- PROBGUT
- Status last verified
- Aug 2018
- First submitted
- 25 Jan 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ProbGut Study: Effects of Probiotics on the Gut Microbiota of Healthy Children
- ClinicalTrials.gov ID
- NCT03430726
- Acronym / sponsor ID
- PROBGUT
- Conditions
- Healthy
- Keywords
- Probiotics; paediatrics; gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Mitacs
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Kids Probiotic Yogurt Drink Group | Experimental | Other: Probiotic yogurt drinkHealthy 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. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants will be healthy children between 1 to 3 years of age.
- Mother of participant is able to communicate in English (read, write, speak), as she will be required to provide her personal and medical history.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic yogurt drinkAlso: Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®)Food product; yogurt drink containing a multi-strain probiotic. | Other | Healthy Kids Probiotic Yogurt Drink Group |
Primary outcome
Composition and Diversity of Gut Microbiota
Time frame: Baseline, 30 days and 90 days
Change in microbial community (e.g. alpha and/or beta diversity) post-probiotic
Levels of Fecal Biomarkers - beta-defensins-2 (hBD-2)
Time frame: Baseline, 21 days, 30 days, and 90 days
Change in levels of beta-defensins-2 (hBD-2)
Levels of Fecal Biomarkers - Fecal Calprotectin
Time frame: Baseline, 21 days, 30 days, and 90 days
Change in levels of Fecal Calprotectin
2 secondary outcomes
Duration of Persistence (DOP)
Time frame: 90 days post intervention
Occurrence of Adverse Events
Time frame: Through study completion, an average of 121 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic yogurt drink in people with Healthy, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition and Diversity of Gut Microbiota (time frame: Baseline, 30 days and 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.