Can Feeding a Bifido Bacteria That Readily Digests Lactose and Galactooligosacharides Improve Lactose Digestion and Tolerance Through Alteration of the Microbiome?

Bifidobacterium adolescentis IVS-1, is a strain of the bacterial species Bifidobacterium adolescentis that has been thoroughly characterized. It is deposited with the American Type Culture Collection (ATCC®) under Patent Deposit Designation as PTA-120614. B. adolescentis IVS-1 is part of the broader group of bacteria within the genus. These bacteria are one of the major genera of microorganisms that make up the gastrointestinal tract microbiota in mammals. Bifidobacterium is also long considered to contribute to a healthy gastrointestinal tract in infants as well as adults. These organisms have been used in food products and dietary supplements for decades, with a record of safe consumption. B. adolescentis IVS-1 is a specially selected strain. Krumbeck et. al. isolated bifidobacteria from fecal samples of human individuals who had consumed the prebiotic GOS during a previous human trial. For this isolation, a combination of approaches was used to select a candidate strain (B. adolescentis strain IVS-1) enriched by GOS in vivo. The subject consumed increasing doses of GOS for nine weeks. A retrospective analysis of the fecal microbiota of one subject revealed an 8-fold enrichment in B. adolescentis strain IVS-1 during GOS administration. Thus, the strain originated from a subject who showed a strong bifidogenic response to GOS. The functionality of GOS to support the establishment of IVS-1 in the gastrointestinal tract was then evaluated in rats. Strain-specific quantitative real-time PCR showed that the addition of GOS increased B. adolescentis IVS-1 abundance in the distal intestine by nearly two logs. Illumina 16S rRNA sequencing not only confirmed the increased establishment of IVS-1 in the intestine but also revealed that the strain was able to outcompete the resident Bifidobacterium population when provided with GOS. The preparation containing Bifidobacterium adolescentis IVS-1 is manufactured at Centro Sperimentale Del Latte srl, Strada Provinciale per Merlino, 3, 26839, 26839 Zelo Buon Persico LO, Italy, in accordance with current good manufacturing practices (cGMPs); approved and recognized by Global Food Safety Initiative. The facility is FSSC 2200 certified.

Bifidus and lactose intolerance:

The use of probiotics, including Bifidobacterium, has had mixed success in improving lactose tolerance. The failures are likely due to dose and strain, as demonstrated in our lab. Supplementation with Bifidobacterium can change the colonic microflora to improve lactose digestion, and changes in the gut microbiome can mediate lactose intolerance symptoms as first shown in our lab and more recently by others. Bifidobacterium adolescentis IVS-1 presents a unique opportunity to evaluate both species and dose of a very well characterized probiotic in improving lactose digestion, altering the microbiome, and improving lactose tolerance.

Study Procedures:

Participants will undergo a pre-Informed Consent phone screening for eligibility. Informed Consent will be obtained. Demographic/ contact information and a departmental Subject Payment Form will be completed. Study staff contact information and study information handout will be provided. Consented participants will then undergo an abbreviated hydrogen breath test (3 hours duration) which involves drinking 8 oz. of 2% fat commercial milk and giving a breath sample and rating any symptoms they might have at 1 and 2 hours post milk dose. Participants who register a hydrogen value of 20ppm or above will be eligible to proceed to Part 1 of the study.