Study: probiotic bacteria lactobacillus acidophilus ncfm and bifidobacterium lactis bi-07 for functional intestinal disorders

Reference

Ringel Y, Ringel-Kulka T, Maier D, et al. Prediotic bacteria lactobacillus acidophilus ncfm and bifidobacterium lactis bi-07 compared to placebo for the symptoms of flatulence in patients with functional intestinal disorders-a double-blind study. J Clin Gastroenterol. March 22, 2011. (Epub before printing)

Design

double -blind, placebo -controlled, randomized clinical study. The duration of studies was 14 weeks, including a two -week inlet phase, an eight -week intervention phase and a four -week follow -up.

participant

Sixty-suitable patients with functional bowel diseases (FBD) without constipation that met the Rome III criteria for irritable bowel syndrome without constipation, functional diarrhea or functional flatulence.

study medication and dosage

Sixty patients were randomized in two parallel arms of intervention: an active probiotic arm and a placebo arm. During the 8-week intervention period, the active probiotic arm (n = 31) received a pill twice a day, consisting of an equal mix lactobacillus acidophilus ncfM and bifidobacterium Animalis sp. Lactis Bi-07, which resulted in 1 × 1011 KBE per pill, while the placebo arm (n = 29) received placebo pills that consisted of microcrystalline cellulose.

target parameter

The ratings were made after 4 and 8 weeks of the intervention period. The two primary endpoints were a worldwide relief of the gastrointestinal symptoms and a satisfaction survey. The secondary endpoints include changes in specific functional GI symptoms (e.g. abdominal pain, flatulence, postprandial symptoms), stool frequency, stool consistency, severity of symptoms, general well-being and a questionnaire on health-related quality of life.

most important knowledge

Although the two primary endpoints were not conclusive, the severity of the abdominal bloating, a secondary end point, was lower in the active probiotic arm compared to the placebo group after 4 weeks lower (4.10 ± 3 vs. 6.17 ± 3). p = 0.009) and after 8 weeks (4.26 ± 3 vs. 5.84 ± 3). p = 0.06). The analysis of the changes before and after the intervention in the severity of the flatulence resulted in a significant improvement in the active probiotic arm compared to the placebo group (-1.58 vs. 0.95) after 4 weeks. p = 0.02) and after 8 weeks (-1.4 vs. 0.6) p <0.01), which corresponds to a reduction in clinical bloating symptoms by 15 %. Analyzes of a subgroup with non -blocked irritable bowel syndrome (IBS) showed similar results. It is important that the genetic analysis of the fecal microbiota confirmed the presence of the probiotic test strains in the intervention group. There was no difference between the groups at the start of the study or at the end of the 8-week intervention between the groups regarding the stool analysis on inflammatory biomarkers. After all, there were no differences in the unwanted events between the intervention and placebo group.

clinical implications

According to the Rome III Diagnostic Criteria Functional Gastrointestinal Disorders (FGIDS), functional flatulence in functional intestinal diseases (FBDS) with irritable bowel syndrome, functional constipation, functional diarrhea and non -referred functional intestinal diseases are divided. Bloating symptoms with other FGIDs, since up to 96 % of IBS patients report on this symptom. In an earlier study with 337 subjects, ringel and colleagues reported that bloating after abdominal pain is the second most littered symptom in irritable bowel syndrome patients and the third most important reason for the search for medical help. ^{3 Nevertheless, the authors point out that due to the current lack of mechanistic understanding there is only a few effective treatment options.}

Probiotics are in the sense of the nutritional and agricultural organization of the United Nations (fao) as" living microorganisms, which are given a health benefit to the inn Give. ” ^{4 Probiotics are often used to treat gastrointestinal symptoms. In particular, the effect of probiotics on flatulence symptoms is the subject of research interest. However, the previous results were generally modest and inconsistent. The current study reported on a partially, significant relief of the bloating symptoms after 4 and 8 weeks of intervention by a combination of two trunk -specific probiotics: lactobacillus acidophilus ncfM and bifidobacterium Animalis sp. Lactis Bi-07. Another study resulted in a similar statistically significant reduction in flatulence in the abdominal cavity after the intervention ( p = 0.046) using a probiotic multi-species mix (VSL#3®), although no comparisons were reported between groups.}

to more general data are available, these effects on flatulence must be assigned to the specific probiotic trunks and doses used in these studies. There are certain concerns among clinicians that probiotic interventions actually have an impact on chair microbiology. It is therefore noteworthy that Ringel and colleagues have carried out a stool analysis of the microbial DNA using QPCR. In the current study, L-NCFM was only detected in the post intervention group in the Fäkalen DNA. B-LBI07 has been demonstrated in all groups, but in a higher concentration after the intervention (PCR primer for B-LBI07 are less specific and can amplify other related trunks). It is important that treatment with combined L-NCFM and B-LBI07 provided good security and compatibility data without significant undesirable events or changes in the blood tests between the starting value, the middle of intervention and the periods after the intervention.

The combination of the probiotic trunks L-NCFM and B-LBI07 at 1 × 1011 KBE BID effectively manipulated the microbiota in patients with FBDs and can offer clinical benefits by reducing the severity of the bloating symptoms in patients with diagnosed irritable bowel syndrome without constipation, functional diarrhea, etc. This study continues to support the argument for the use of multi-spezies probiotics as a means of treating various gastrointestinal symptoms in patients with FBDS.