Acidophilus Pearls Fecal Recovery Study

NCT02001610 | Completed

• 2 other identifiers: IRB201300549PS Project 00090915
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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 (Unpublished studies conducted at SNA research facility, February, 2010.)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.

Conditions

Survival of Probiotics During GI Transit; GI Symptoms

Keywords

microbiota; probiotics; fecal markers

Outcome Measures

Primary Outcomes (1)

• Change in fecal survival of probiotics

  The investigators will measure survival of the probiotics in fecal samples.

  Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19

Secondary Outcomes (1)

• GI symptoms

  Day 7-9 and day 10-12

Other Outcomes (1)

• Fecal markers

  Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19

Study Arms (2)

Hard shell gelatin capsules

ACTIVE COMPARATOR

* 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

Dietary Supplement: Hard shell gelatin capsules

Acidophilus pearls

EXPERIMENTAL

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

Dietary Supplement: Acidophilus pearls

Interventions

Acidophilus pearls DIETARY_SUPPLEMENT

* Acidophilus pearls are encapsulated using patented process * Subjects take one capsule (containing at least 1 x 10\^9 colony forming units) every morning for 12 days

Acidophilus pearls

Hard shell gelatin capsules DIETARY_SUPPLEMENT

* Hard-shelled gelatin capsule with same microbial formulation as pearl supplement * Subjects consume one capsule (containing at least 1 x 10\^9 colony forming units) every morning for 12 days

Hard shell gelatin capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Schwabe North America: collaborator

Study Sites (1)

Emerging Pathogens Institute

Gainesville, Florida, 32610, United States

Location

Study Officials

• Volker Mai, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: December 5, 2013
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 8, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)