The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults (PIP)
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|ClinicalTrials.gov Identifier: NCT03611400|
Recruitment Status : Active, not recruiting
First Posted : August 2, 2018
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Barrier Function||Dietary Supplement: Probiotic Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||A randomized, double-blind, placebo-controlled crossover in which participants receive one of the study supplements (probiotic or placebo) for a 3-week intervention period each will be used.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The participants, investigators, and anyone else involved with the study will remain blinded for its entirety.|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Probiotic Intake on Intestinal Permeability of Healthy Adults|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
2 capsules daily for 3 weeks, containing 3.8 x 10^9 CFU (colony forming units)/capsule of Lactobacillus rhamnosus strain R011and 0.2 x 10^9 CFU/capsule of L. helveticus strain R0052 (group is unknown, double blinded)
Dietary Supplement: Probiotic
This probiotic is commercially available and contains L. helveticus R0052 (0.2 x 10^9 CFU/capsule) and L. rhamnosus R0011 (3.8 x 10^9 CFU/capsule) as active ingredients and ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide, and maltodextrin as excipients.
Other Name: Lacidofil STRONG
Placebo Comparator: Placebo
2 capsules daily for 3 weeks containing the same carrier material and is similar in size, shape and taste to probiotic (group is unknown, double blinded)
Dietary Supplement: Placebo
The placebo contains ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide and maltodextrin.
- Gastroduodenal Permeability [ Time Frame: Week 2 of each intervention ]The primary outcome is the difference between the changes in gastroduodenal permeability induced by aspirin challenge with the probiotic versus the placebo. Gastroduodenal permeability will be assessed while on the placebo and probiotic interventions by measuring urinary sucrose in the 0 to 5-hour urine collection of the sugar probe permeability test. Change will be calculated as the urinary sucrose concentration after aspirin challenge (week 2 of each intervention) minus the concentration from the prior week (i.e., 1 wk on intervention with no aspirin challenge).
- Small Intestinal Permeability [ Time Frame: Weeks 1 and 2 on intervention ]Difference between the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in urinary lactulose/rhamnose ratio in the 0 to 5-hour urine collection with the probiotic versus the placebo interventions.
- Colonic Permeability [ Time Frame: Weeks 1 and 2 on intervention ]Difference between the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in sucralose/erythritol ratio in the 5 to 24-hour urine collection with the probiotic versus the placebo interventions.
- Whole Gut Permeability [ Time Frame: Weeks 1 and 2 on each intervention ]difference in the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in sucralose/erythritol ratio in the 0 to 24-hour urine collection with the probiotic versus the placebo interventions
- Digestive Health [ Time Frame: Weekly through the completion of the 14 week study ]Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS consists of 15 questions related to 5 syndromes, constipation, diarrhea, reflux, abdominal pain, and indigestion. Symptoms are scored 1=no discomfort to 7=very severe discomfort. Scores from each of the 15 questions are summed for the total GSRS score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611400
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611-0370|
|Principal Investigator:||Bobbi Langkamp-Henken, PhD||University of Florida|