Efficacy of a Preparation Based on Calcium Butyrate, Bifidobacterium bifidum, Bifidobacterium lactis, and Fructooligosaccharides in the Prevention of Relapse in Ulcerative Colitis: A Prospective Observational Study

Abstract

Several compounds based on short chain fatty acids and/or probiotics/prebiotics have shown promising results in the therapy of ulcerative colitis (UC), possibly due to its key role in restoring gut homeostasis as well as intestinal barrier integrity. Here, we investigated the efficacy of a patented preparation based on calcium butyrate, Bifidobacterium bifidum, Bifidobacterium lactis, and fructooligosaccharides (FEEDColon®, Princeps, Cuneo, Italy) in maintaining remission and improving subjective symptoms and inflammatory indices in patients with UC receiving 5-ASA therapy. A total of 42 patients were prospectively recruited and randomized in 21 patients receiving combination therapy with mesalamine (5-ASA) plus FEEDColon® and 21 patients treated with standard 5-ASA therapy. Patients were assessed at baseline, at 6-month, and 12-month follow-up (FU). Therapeutic success (defined as Mayo partial score ≤ 2 and faecal calprotectin (FC) < 250 µg/g at 12-month FU) was reached by 32 (76%) patients: 20 (95%) among those treated with 5-ASA + FeedColon®, and 12 (57%) among those treated with 5-ASA only (p = 0.009). Consistently, patients treated with combination therapy improved subjective symptoms (quality of life, abdominal pain, and stool consistency) and reduced FC values, while those treated with 5-ASA alone, improved neither subjective symptoms nor FC during the FU. In conclusion, FEEDColon® supplementation appears to be a valid add-on therapy for the maintenance of remission in patients with UC. Further multicentre, placebo-controlled, double-blind clinical trials are needed to validate our results on larger cohorts of patients with UC.

Probiotic-Based Intervention in the Treatment of Ulcerative Colitis: Conventional and New Approaches

“…Moreover, their standalone administration can lead to the suppression of inflammation as well as changes in microbial composition and metabolism associated with increased SCFA production [ 106 ]. Some clinical trials have shown that the intake of synbiotics (probiotics together with prebiotics) seems to also be an effective method of UC management [ 97 , 99 , 107 , 108 ]. Reduced sigmoidoscopy scores and inflammation, the regeneration of epithelial tissue, and reduced expression of β-defensins and the pro-inflammatory cytokines TNF-α and IL-1α were documented after 6 weeks of synbiotic supplementation composed of B. longum and a fructooligosacharide/inulin mix in patients with active UC [ 107 ].…”

“…Patients with longer durations of active disease responded significantly better to the intervention (with Lactocare ® ) compared to those with shorter ones (less than 5 years). Furthermore, synbiotics with conventional medication as a combinational therapy appeared to be more effective in improving subjective symptoms such as quality of life, abdominal pain, and stool consistency [ 108 ]. A selection of recent clinical trials in which probiotics alone, in combination with prebiotics, or as an adjuvant therapy to 5-ASA have shown promising outcomes in UC, both active and in remission, are listed in Table 1 .…”

Microbial Metabolite Regulation of Epithelial Cell-Cell Interactions and Barrier Function

“…These findings suggest that inflammation is directly related to SCFAs (specifically butyrate) synthesis, uptake, and metabolism, suggesting that SCFAs supplementation alone may not be sufficient to regain homeostasis. Promising combined clinical approaches utilizing butyrate and butyrate-producing bacteria have resulted in prevention of relapse in IBD patients [127,128]. Collectively, these findings demonstrate the importance SCFAs in gut health and that a combination of approaches to regain butyrate uptake and metabolism may be a promising treatment in the clinical management of IBD.…”

Evolutionary Insights Into Microbiota Transplantation in Inflammatory Bowel Disease

“…found that FEEDColon ® (consists of Bifidobacterium bifidum, Bifidobacterium lactis , calcium butyrate and oligosaccharides) was an effective adjunctive therapy for prolonged UC remission. Further analysis revealed that the remission rate of 5-ASA + FEEDColon ® was greater than of 5-ASA alone (95% > 57%) (P = 0.009) ( Caviglia et al., 2021 ).…”

“…In addition, polyphenols and polyunsaturated fatty acids, which act on gut microbes, are also classified as prebiotics. Example of this type of combination include Profermin ® ( Krag, 2012 ), FEEDColon ® ( Caviglia et al., 2021 ) and YBF ( ClinicalTrials.gov, 2010 ).…”