Study: Probiotic bacteria Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis Bi-07 in functional intestinal disorders

reference

Ringel Y, Ringel-Kulka T, Maier D, et al. Probiotic bacteria Lactobacillus Acidophilus NCFM and Bifidobacterium Lactis Bi-07 compared to placebo for symptoms of flatulence in patients with functional bowel disorders - a double-blind study.J Clin Gastroenterol.March 22, 2011. (Epub ahead of print)

design

Double-blind, placebo-controlled, randomized clinical trial. The study duration was 14 weeks in total, including a two-week run-in period, an eight-week intervention period and a four-week follow-up period.

Participant

Sixty eligible patients with functional bowel disease (FBD) without constipation who met Rome III criteria for irritable bowel syndrome without constipation, functional diarrhea, or functional flatulence.

Study medications and dosage

Sixty patients were randomized into two parallel intervention arms: an active probiotic arm and a placebo arm. During the 8-week intervention period, the active probiotic arm (n=31) received a pill consisting of an equal mixture twice dailyLactobacillus acidophilusNCFM andBifidobacterium animalis sp. LactisBi-07, which yielded 1×1011 CFU per pill, while the placebo arm (n=29) received placebo pills composed of microcrystalline cellulose.

Target parameters

Assessments were made at 4 and 8 weeks of the intervention period. The two primary endpoints were global gastrointestinal symptom relief and a satisfaction survey. Secondary outcomes included changes in specific functional GI symptoms (e.g., abdominal pain, bloating, postprandial symptoms), stool frequency, stool consistency, symptom severity, general well-being, and a health-related quality of life questionnaire.

Key findings

Although the two primary endpoints were inconclusive, abdominal distension severity, a secondary endpoint, was lower in the active probiotic arm compared to the placebo group at 4 weeks (4.10 ± 3 vs. 6.17 ± 3).P=0.009) and after 8 weeks (4.26 ± 3 vs. 5.84 ± 3).P=0.06). Analysis of pre- and post-intervention changes in bloating severity revealed a significant improvement in the active probiotics arm compared to the placebo group at 4 weeks (-1.58 vs. 0.95).P=0.02) and after 8 weeks (-1.4 vs. 0.6)P<0.01), corresponding to a 15% reduction in clinical flatulence symptoms. Analyzes of a subgroup with nonconstipated irritable bowel syndrome (IBS) showed similar results. Importantly, genetic analysis of the fecal microbiota confirmed the presence of the probiotic test strains in the intervention group. There were no differences between groups in stool analysis for inflammatory biomarkers either at baseline or at the end of the 8-week intervention. Finally, there were no differences in adverse events between the intervention and placebo groups.

Clinical implications

According to the Rome III Diagnostic Criteria Functional Gastrointestinal Disorders (FGIDs), functional bloating is classified into functional bowel diseases (FBDs) with irritable bowel syndrome, functional constipation, functional diarrhea and unspecified functional bowel diseases.^1.2Interestingly, bloating symptoms overlap with other FGIDs, as up to 96% of IBS patients report this symptom. In a previous study of 337 subjects, Ringel and colleagues reported that bloating was the second most bothersome symptom in irritable bowel syndrome patients after abdominal pain and the third most important reason for seeking medical help.³Nevertheless, the authors point out that there are few effective treatment options due to the current lack of mechanistic understanding.

Probiotics are in the sense of Food and Agriculture Organization of the United Nations (FAO) as “live microorganisms that, when administered in sufficient quantities, confer a health benefit to the host.”⁴Probiotics are often used to treat gastrointestinal symptoms. In particular, the effect of probiotics on flatulence symptoms is the subject of research interest. However, results to date have generally been modest and inconsistent. The current study reported partial, significant relief of bloating symptoms after 4 and 8 weeks of intervention by a combination of two strain-specific probiotics:Lactobacillus acidophilusNCFM andBifidobacterium animalis sp. LactisBi-07. Another study found a similar, statistically significant reduction in abdominal bloating after the intervention (P=0.046) using a multispecies probiotic mixture (VSL#3®), although no comparisons between groups were reported.⁵

Until more general data are available, these effects on bloating must be attributed to the specific probiotic strains and doses used in these studies. There is some concern among clinicians that probiotic interventions actually have effects on stool microbiology. Therefore, it is noteworthy that Ringel and colleagues performed stool analysis of microbial DNA using qPCR. In the current study, L-NCFM was detected in fecal DNA only in the post-intervention group. B-LBi07 was detected in all groups, although at a higher concentration after the intervention (PCR primers for B-LBi07 are less specific and may amplify other related strains). Importantly, treatment with combined L-NCFM and B-LBi07 provided good safety and tolerability data, with no significant adverse events or changes in blood tests reported between baseline, mid-intervention, and post-intervention periods.

The combination of probiotic strains L-NCFM and B-LBi07 at 1×1011 CFU BID effectively manipulates the microbiota in patients with FBDs and may provide clinical benefit by reducing the severity of flatulence symptoms in patients diagnosed with irritable bowel syndrome without constipation, functional diarrhea, etc. Functional flatulence. This study further supports the argument for the use of multispecies probiotics as a means to treat various gastrointestinal symptoms in patients with FBDs.