Acidophilus Pearls Fecal Recovery Study

University of Florida

Status: Completed

Conditions: GI Symptoms; Survival of Probiotics During GI Transit

Treatments: Dietary Supplement: Acidophilus pearls; Dietary Supplement: Hard shell gelatin capsules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02001610

IRB201300549

PS Project 00090915 (Other Identifier)

Details and patient eligibility

About

Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not remain viable throughout the rest of the GIT. (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule will survive gastric exposure. It is anticipated that this difference in in vitro gastric survivability will translate to improved digestive tract survivability that can be demonstrated using fecal recovery techniques.

The commercial product to be tested in this clinical trial has been in the market for over 17 years. However, it is not known what effect this commercial product has on the commensal probiotic population in the gut and particularly in the lower bowel where much of probiotic benefits are believed to be largely realized. Also, it is not known what effect the commercial product has on the total commensal microbiota or fecal pH. While commercial probiotic products have been largely aimed at benefits related to improved health, they also have the potential to change overall gut microbiota (probiotics as well as all others) composition and activities. Learning what happens to the overall gut microbiota can be a helpful step in establishing the potential health benefits of the probiotic class of organisms in the test products.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult
• Regular and predictable bowel movement pattern
• Willing to disclose OTC/prescription medications and dietary supplements taken during the study
• Willing to sign comprehensive informed consent form

Exclusion criteria

• Digestive disorders
• Use of prescribed medications that affect bowel function or microbiota (antibiotics, pain medications, laxatives)
• Use of dietary supplements/foods that can affect bowel function or microbiota
• Excessive alcohol use

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Hard shell gelatin capsules

Active Comparator group

Description:

* Comparison delivery vehicle in the form of gelatin capsule * One capsule (containing at least 1 x 10\^9 colony forming units) every morning for 12 days

Treatment:

Dietary Supplement: Hard shell gelatin capsules

Acidophilus pearls

Experimental group

Description:

* Encapsulated using patented process * One capsule (containing at least 1 x 10\^9 colony forming units) every morning for 12 days

Treatment:

Dietary Supplement: Acidophilus pearls