Probiotic Vivomixx May Help to Restore Gut Microbiome, Ease CFRD

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Treatment with the probiotic Vivomixx appeared to lead to healthful changes in the gut microbiome of cystic fibrosis (CF) patients in a small clinical trial, including six with CF-related diabetes (CFRD), that may improve glucose metabolism.

The study, “The effect of probiotic administration on metabolomics and glucose metabolism in CF patients,” was published in the journal Pediatric Pulmonology.

Many people with CF experience digestive issues, and up to half of adults with CF develop CFRD, which is characterized by problems in the body’s ability to metabolize glucose.

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Dysbiosis — disease-associated changes in the makeup of the gut microbiome, the friendly microbes living in the digestive tract — is common in people with CF, and may contribute to these issues. Probiotics are supplements containing specific strains of bacteria designed to promote a more healthful gut microbiome.

Researchers in Italy and Israel conducted a clinical trial to test Vivomixx, a probiotic containing eight bacterial strains, in people with CF.

“We aimed to assess the effect of Vivomixx administration on clinical outcomes, metabolomics, inflammatory parameters, and glucose metabolism in CF patients,” the team wrote. Metabolomics refers to the large-scale study of small molecules, collectively known as the metabolome, within cells, biofluids, tissues, or organisms.

“To the best of our knowledge, this is the first study to examine the effect of probiotics on glucose metabolism and metabolomics in CF patients,” the scientists added.

The study enrolled 23 people with CF; most (52%) were female and the group’s mean age was about 17. Six patients had CFRD and were on standard insulin treatment.

Patients took Vivomixx daily for four months. Those younger than 12 received one sachet of Vivomixx each day, those between 12 and 18 took two sachets daily, and those older than 18 received two sachets twice a day. The probiotic treatment was generally well-tolerated, with no significant side effects reported.

Digestion-related quality of life, assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), improved significantly after two months on Vivomixx. By the end of the four-month trial, however, quality of life scores had decreased again until they were similar to scores at its start.

“Our study showed a transient improvement in the digestive symptom domain in CFQ-R,” the researchers wrote. They speculated that this pattern may be because participants were more likely to be taking the probiotic as instructed during earlier than later trial months, but “further conclusions cannot be made.”

Some patients “complained about the taste,” the study noted, and were advised to mix the powdered probiotic with cold foods such as yogurt or ice cream.

Analyses of 16 participants’ urine at the trial’s start and end showed that Vivomixx led to a significant increase in levels of several molecules related to glucose metabolism: namely, cysteine, lactulose, arabinose, mannitol, and indole 3-lactate. Significant decreases were observed in urinary levels of 3-methylhistidine and N-Acetyl glutamine, and also in stool levels of 2-hydroxyisobutyrate and 3-methyl-2-oxovalerate, based on data from seven participants.

These changes were significant in patients with and without CFRD, the researchers noted.

“In this single-center prospective pilot study, probiotic administration in CF patients resulted in significant changes in stool and urine metabolomics,” the team wrote. “The change in metabolites profile suggests a positive effect of Vivomixx on glucose metabolism in these patients.”

Researchers stressed that this study is limited by its small size, and by the lack of a control group of patients on a placebo.

“Larger, randomized double blind placebo-controlled studies using different probiotics products, will help in extending our knowledge,” the scientists wrote. “Understanding the interplay between microbial imbalance, inflammation, and glucose metabolism in CF may be beneficial in preventing CFRD.”