The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults

NCT03611400 | Completed

• 2 other identifiers: IRB201800616OCR18441
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Keywords

Probiotic; Intestinal Permeability; Leaky Gut

Outcome Measures

Primary Outcomes (1)

• Gastroduodenal Permeability

  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).

  Week 2 of each intervention

Secondary Outcomes (3)

• Small Intestinal Permeability

  Weeks 1 and 2 on intervention

• Colonic Permeability

  Weeks 1 and 2 on intervention

• Whole Gut Permeability

  Weeks 1 and 2 on each intervention

Other Outcomes (1)

• Digestive Health

  Weekly through the completion of the 14 week study

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Probiotic 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.

Also known as: Lacidofil STRONG

Probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611-0370, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Bobbi Langkamp-Henken, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, investigators, and anyone else involved with the study will remain blinded for its entirety.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: August 2, 2018
• Study Start: August 22, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)