The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults (PIP)
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|ClinicalTrials.gov Identifier: NCT03611400|
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : June 21, 2019
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|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|
|Actual Primary Completion Date :||April 15, 2019|
|Actual Study Completion Date :||April 15, 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.
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|Ages Eligible for Study:||21 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Healthy individuals, aged 21 to 50 years who have ≥6 stools/week.
- Willing to discontinue the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, naproxen, or indomethacin, for the full length of the study.
- Willing to avoid beer, wine, and cocktails on the day before and the day of the sugar probe tests. The sugar probe tests are visits 2, 3, 4, 6, 7, and 8.
- Willing to avoid the use of antidiarrheal or laxative medication on a regular or an "as-needed basis" during the full length of the study.
- Willing to provide urine and stool samples during the study collection periods.
- Have used aspirin in the past and did not experience adverse effects.
- Willing to consume three tablets (325 mg each or 975 mg total) twice within a 9 to 12-hour period. This challenge will be repeated twice during the 14-week study.
- Willing to complete online questionnaires, records, and diaries associated with the study and to complete all clinic visits.
- Willing to discontinue consumption of fermented foods or probiotics.
- Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact immune function or inflammation during the pre-baseline period and throughout the study protocol.
- Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on six occasions.
- Willing and able to consume the probiotic and placebo daily for 3 weeks each.
- Willing and able to complete the informed consent form in English.
- Willing to provide a social security number to receive study payment.
- History or current impaired cardiovascular circulation or uncontrolled hypertension, diabetes, bleeding tendencies, kidney, liver or chronic respiratory diseases including asthma, gastrointestinal disorders including heartburn, or any other disease, that by the investigators discretion could interfere with the intestinal barrier function of the subject.
- Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
- Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin/mineral supplements.
- Allergy to aspirin, milk, yeast, or soy.
- Known sensitivity to gluten.
- Current smokers.
- Women who are lactating, know that they are pregnant, or are attempting to get pregnant.
- Use of another investigational product within 3 months of the screening visit.
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|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
OCR18441 ( Other Identifier: University of Florida )
|First Posted:||August 2, 2018 Key Record Dates|
|Last Update Posted:||June 21, 2019|
|Last Verified:||June 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|