Clinical trial NCT03611400: The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults
Official title: The Effect of Probiotic Intake on Intestinal Permeability of Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Barrier Function
Keywords: Probiotic
Intestinal Permeability
Leaky Gut
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Lallemand Health Solutions
First posted: 2018-08-02
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Gastroduodenal Permeability
timeFrame: Week 2 of each intervention
Secondary outcomes:
measure: Small Intestinal Permeability
timeFrame: Weeks 1 and 2 on intervention
measure: Colonic Permeability
timeFrame: Weeks 1 and 2 on intervention
measure: Whole Gut Permeability
timeFrame: Weeks 1 and 2 on each intervention
Other outcomes:
measure: Digestive Health
timeFrame: Weekly through the completion of the 14 week study
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD
role: PRINCIPAL_INVESTIGATOR
References: