A Randomised, Double-blinded, Placebo-controlled Study of the probiotic PCC(Registered Trademark) (L. fermentum VRI-003) capsule for the effect on gastrointestinal health and gut microflora in healthy adults (with no medically diagnosed gastrointestinal disease)

A proof-of-concept study to investigate the effect of ingestion of the probiotic PCC(Registered Trademark) (L. fermentum VRI-003) or placebo capsules on gut health when given to healthy adults (with no medically diagnosed gastrointestinal disease)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001052426

Acronym

“The BBIG Study” (Bioxyne’s Bacteria in Gut Study)

Enrollment

Registered

2016-08-05

Start date

2016-11-02

Completion date

2016-12-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The complex ecosystem of the adult intestinal microflora is estimated to harbour at least 500 different anaerobic bacterial species. Several reports have indicated that five genera account for most of the viable forms of anaerobic bacteria: Bacteroides, Eubacterium, Bifidobacterium, Peptostreptococcus, and Fusobacterium. Some of these species are considered potentially harmful because of their capacity to produce toxins, invade mucosal cells and activate carcinogens and inflammatory responses. There are, however, known strains with health-promoting properties, principally Bifidobacteria and Lactobacilli. This study will examine the capacity of a human-isolated probiotic strain of bacteria to influence the composition of the gut microbiome in healthy adult human volunteers and to examine what health benefits may be associated with daily consumption of the strain in the form of freeze-dried powder in capsules. The strain that will be tested in this study is Lactobacillus fermentum VRI-003, referred to as “PCC(Registered Trademark)”. PCC(Registered Trademark) has been sold as a dietary supplement in capsule and powder form for over ten years worldwide with no reported adverse effect. The study is a proof of concept, single centre, randomised, double-blind placebo controlled, parallel group study. A total of 60 healthy adult subjects (no diagnosed GI disease) will be randomised in a 1:1 ratio to receive either PCC(Registered Trademark) or placebo over a 6 month treatment period. Each active capsule contains a minimum of two billion live organisms. There will be 4 study visits in total. Subjects will provide three faecal samples: at Visit 2 (baseline, Day 1), Visit 3 (day 90) and Visit 4 (day 180). The samples will be analysed by 16S RNA analysis to monitor the composition of the gut microbiome. Subjects will be asked to complete a daily diary regarding their bowel habits. Subjects will also be asked to complete a general health questionnaire (SF-36) on three occasions. Weight will also be recorded.

Interventions

Treatment Arm 1: One capsule of PCC (containing Lactobacillus fermentum VRI-003) once daily for six months. Each active capsule contains a minimum of two billion live organisms. Treatment Arm 2: One capsule of placebo capsule (containing microcrystalline cellulose, MCC) once daily for six months. Adherence will be monitored through participant self report on daily diary and through accountability of empty containers/number capsule returned.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Subject is in general good health with NO history of medically diagnosed gastrointestinal disease.

Exclusion criteria

Any medically diagnosed gastrointestinal disorder/disease (including inflammatory bowel disease, medically diagnosed IBS) Clinically significant renal, hepatic, endocrine, cardiac, pulmonary, pancreatic, neurologic, haematologic or biliary disorder

Outcome results