Quantification of Changes in Bifidobacteria and Lactobacilli Colony-forming Units During Rifaximin Treatment and Synbiotic Gel in Healthy Volunteers

Summary

This clinical trial evaluated counts of bifidobacteria and lactobacilli after 1 week of rifaximin treatment and a Synbiotic Gel composed of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi07, with agave inulin, during the rifaximin treatment and 4 weeks after, compared with a placebo gel, showing that the Synbiotic Gel may help maintain lactobacilli and bifidobacteria.

Abstract

Although the gut microbiota is generally stable, it can be influenced by antibiotic treatment. Rifaximin, which is used to treat gastrointestinal disorders, is frequently administered with probiotics to reduce the risk of dysbiosis. Lactobacillus acidophilus interacts with intestinal cells and uses prebiotic compounds. Bifidobacteria, particularly Bifidobacterium infantis ssp. lactis Bi07, is a probiotic that has been associated with beneficial effects in the gut. In vitro studies have demonstrated the superiority of agave fructans over chicory inulin. No studies have documented changes in fecal lactobacilli and bifidobacteria counts following the concomitant administration of rifaximin and synbiotic. Our objective was to evaluate changes in the CFU counts of gut bifidobacteria and lactobacilli in healthy volunteers after consumption of Synbiotic Gel, which contains Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bi07, and agave inulin as a prebiotic, during 1 week of rifaximin treatment and for 4 weeks after. In a randomized, placebo-controlled, double-blind clinical trial, healthy participants without antimicrobial treatment in the previous month were randomized 1:1 in two groups (10 participants per group). The Synbiotic Gel group received 10.32 g of agave inulin as a prebiotic and 4 × 10⁹ CFU/g of Lactobacillus acidophilus NCFM and 4 × 10⁹ CFU/g of Bifidobacterium lactis Bi07 per day, for 5 weeks, and 200 mg rifaximin twice a day for the first week. The Placebo Gel group received placebo gel for 5 weeks and 200 mg rifaximin twice a day for the first week. Bacterial changes were estimated by quantifying CFU by microbiological assessment of feces. Five weeks later, the lactobacilli and bifidobacteria populations did not change. The detection of Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi07 in some stool samples suggests transient and partial colonization, highlighting the need for dose-response studies with this synbiotic product.

Introduction

The human gut microbiota is a densely populated community that includes permanently present native species and other transient microorganisms. Although its composition can vary between individuals, it is generally considered stable. However, it can be influenced by age, infection, and antibiotic treatment^1,2,3. Rifaximin, a broad-spectrum antibiotic with low intestinal absorption, is used to treat intestinal disorders and can alter microbiota. Probiotic bacteria from the genera Lactobacillus and Bifidobacterium are used to mitigate these effects

Protocol

The protocol was approved by the Institutional Committee for Biomedical Research in Humans (CIIBH) of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran (INCMNSZ) (REFERENCE 1734). All participants provided informed consent before being included in this study.

Study design and population

This was a randomized, placebo-controlled, double-blind clinical trial with a 5-week follow-up period. Workers of the INCMNSZ were invited to participate in the study, and healthy volunteers aged 20–50 years without antimicrobial treatment in the previous month who accepted and ....

Results

Twenty healthy volunteers were randomly divided into the Synbiotic Gel group (n = 10) and Placebo Gel group (n = 10) (Figure 2 and Table 1). In the Synbiotic Gel group, seven were men, and three were women, with a median age of 31 years (range, 27–35 years); in the Placebo Gel group, three were men, and seven were women, with a median age of 33 years (range, 28–38 years). The groups were similar in terms of age, sex, weight, and BMI. Treatment adherence was .......

Discussion

In the present study, we found a significant reduction in enterobacterial counts in the fecal samples of subjects in the placebo group from the first week of intervention and in subjects in the Synbiotic Gel group in the first and second weeks. This change can be explained using rifaximin, which has been described as mitigating pathogenic bacterial overgrowth¹⁴. In our study, the Synbiotic Gel group following rifaximin showed a positive effect: the median population of Lactobacillus strain did not.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
BBL tube	NA	NA	Any brand can be used
DP medium	NA	NA	Any brand can be used
Frozen gel packs
MacConkey medium	NA	NA
MRS medium	NA	NA	Any brand can be used
PBG vial			Phosphate buffer, gelatine, salts 0.05% cysteine as reducing agent for02
Petri dishes
Placebo Blend	KuragoBiotek-BabyCat.	NA	Same physical and sensory properties as the sym iotic gel, but without the active ingredients
Styrofoam continer
Symbiotic blend	KuragoBiotek-BabyCat.	NA	Non-dairy product composed of Lactobacillus acidophilus NCMF and Bifidobacterium infantis Bi-07 (2 x 109 CFU/g), and 17.2 g of agave inulin as a prebiotic in a pack of 15 g