The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults

NCT ID: NCT03611400

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2019-04-15

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.

Conditions

Intestinal Barrier Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

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.

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The placebo contains ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide and maltodextrin.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo contains ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide and maltodextrin.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lacidofil STRONG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lallemand Health Solutions

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bobbi Langkamp-Henken, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

OCR18441

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201800616

Identifier Type: -

Identifier Source: org_study_id