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The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults (PIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611400
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : June 21, 2019
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
In this double blind, crossover study participants will take a placebo for 3 weeks each. Gut permeability will be assessed weekly using food-grade sugar molecules. On the second week, participants will take aspirin, which will make their intestine permeable to the sugars. Participants will be asked to provide urine and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the probiotic.

Condition or disease Intervention/treatment Phase
Intestinal Barrier Function Dietary Supplement: Probiotic Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
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
Arms and Interventions
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Arm Intervention/treatment
Experimental: Probiotic
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Healthy individuals, aged 21 to 50 years who have ≥6 stools/week.
  2. 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.
  3. 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.
  4. 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.
  5. Willing to provide urine and stool samples during the study collection periods.
  6. Have used aspirin in the past and did not experience adverse effects.
  7. 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.
  8. Willing to complete online questionnaires, records, and diaries associated with the study and to complete all clinic visits.
  9. Willing to discontinue consumption of fermented foods or probiotics.
  10. 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.
  11. 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.
  12. Willing and able to consume the probiotic and placebo daily for 3 weeks each.
  13. Willing and able to complete the informed consent form in English.
  14. Willing to provide a social security number to receive study payment.

Exclusion Criteria

  1. 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.
  2. Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
  3. 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.
  4. Allergy to aspirin, milk, yeast, or soy.
  5. Known sensitivity to gluten.
  6. Current smokers.
  7. Women who are lactating, know that they are pregnant, or are attempting to get pregnant.
  8. Use of another investigational product within 3 months of the screening visit.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611-0370
Sponsors and Collaborators
University of Florida
Lallemand Health Solutions
Investigators
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Principal Investigator: Bobbi Langkamp-Henken, PhD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03611400    
Other Study ID Numbers: IRB201800616
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Probiotic
Intestinal Permeability
Leaky Gut