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Prebiotic

Prebiotic for Healthy Subjects

N/A

Waitlist Available

Led By Raylene Reimer, PhD, RD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks in cross-over design

Awards & highlights

Study Summary

This trial will test the effect of two doses of prebiotic on gut microbiota taxonomy and diversity in order to identify the dosing requirements to positively modulate the gut microbiota.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks in cross-over design

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks in cross-over design

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks in cross-over design for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in baseline fecal bifidobacteria at 4 weeks

Secondary outcome measures

Change in baseline fecal short chain fatty acid concentrations at 4 weeks

Change in baseline gastrointestinal tolerance at 4 weeks

Change in baseline quality of life rating at 4 weeks

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PrebioticExperimental Treatment1 Intervention

Prebiotic consumed as one daily serving of 7 g in Group 1 and consumed as one daily serving of 2.5-3 g in Group 2.

Group II: ControlPlacebo Group1 Intervention

Isocaloric food without the test prebiotic.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prebiotic

2016

Completed Phase 2

~720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

787 Previous Clinical Trials

846,258 Total Patients Enrolled

General MillsIndustry Sponsor

21 Previous Clinical Trials

1,559 Total Patients Enrolled

Raylene Reimer, PhD, RDPrincipal InvestigatorUniversity of Calgary

1 Previous Clinical Trials

53 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study population include any participants below the age of 30?

"Patients between the ages of 18 to 65 are eligible for this medical trial; however, there are separate trials available catering specifically to those younger and older than this age range. 50 studies focus on participants under 18 years old while 371 exist for seniors over 65."

Answered by AI

To whom is this clinical experiment open for participation?

"This investigation is searching for 50 people aged 18 to 65 who meet the following requirements: BMI between 18.5 and 29.9, stable bodyweight for 3 months preceding the study, healthy male or female regular snackers."

Answered by AI

Are more participants still being invited to join this research?

"The information on clinicaltrials.gov indicates that this medical study is not enrolling patients at present, which was first posted in May 15th 2016 and last updated on May 17th 2022. However, there are 839 other trials actively looking for participants right now."

Answered by AI

Recent research and studies

The American Journal of Clinical NutritionJournal

Effect of Chicory Inulin-type Fructan–containing Snack Bars on the Human Gut Microbiota in Low Dietary Fiber Consumers in a Randomized Crossover Trial

Reimer, Raylene A, Adriana Soto-Vaca, Alissa C Nicolucci, Shyamchand Mayengbam, Heekuk Park, Karen L Madsen, Ravi Menon, and Elaine E Vaughan. 2020. “Effect of Chicory Inulin-type Fructan–containing Snack Bars on the Human Gut Microbiota in Low Dietary Fiber Consumers in a Randomized Crossover Trial”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.1093/ajcn/nqaa074.

clinicaltrials.govStudy

Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults

Dr. Raylene Reimer 2016. "Effect of Prebiotic Intake on Gut Microbiota in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03042494.