LactoBi ProBiotic Complex - Clinical Trials

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Indication: dysbacteriosis, constipation, unstable stool, traveler’s diarrhea prophylaxis, damaged intestinal lining, long term drug treatment.

Actions: normalizes intestinal microflora, suppresses pathogenic bacteria, essential after antibiotic therapy, improves digestion and metabolism, strengthens the immune system, recommended for allergy sufferers, contains unique soluble dietary fiber Fibersol 2™.

Ingredients (per one packet – 5.5 g):

Probiotic Blend - 2.3 billion CFU: Bifidobacterium bifidum, Lactobacillus acidophilus, Bifidobacterium longum, Lactobacillus casei, Lactobacillus rhamnosus; Calcium (as calcium carbonate) - 40 mg; Xylitol - 50 mg; Fibersol 2 (soluble dietary fiber) - 5000 mg.


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ProBiotic Complex - Clinical Trials:

Department of Food Science, National Chung Hsing University, Taichung, Taiwan.

The antioxidative effect of intact cells and intracellular cell-free extracts of intestinal lactic acid bacteria B. longum (ATCC 15708) and L. acidophilusB. longum and L. acidophilus demonstrated antioxidative activity, inhibiting linoleic acid peroxidation by 28-48%. This indicated that these two strains demonstrated excellent antioxidative activity. B. longum and L. acidophilus also showed the ability to scavenge alpha,alpha-diphenyl-beta-picrylhydrazyl (DPPH) free radical, scavenging 21-52%. The intact cells of these two intestinal bacteria demonstrated a high inhibitory effect on the cytotoxicity of 4-nitroquinoline-N-oxide (4NQO). Cytotoxicity of 4NQO was reduced by L. acidophilus by approximately half and by almost 90% by B. longum. Nevertheless, no inhibition of cytoxicity observed for intracellular cell-free extracts of 10(9) cells of B. longum and L. acidophilus. The effect of B. longum and L. acidophilus on inhibiting plasma lipid peroxidation was also evaluated. The results showed that both intestinal strains were able to protect plasma lipid from oxidation at different degrees. The inhibition rates on plasma lipid peroxidation ranged from 11 to 29% for 10(9) cells of B. longum and L. acidophilus. Generally speaking, B. longum demonstrated better antioxidative ability than L. acidophilus in this study. (1)



Small bowel bacterial overgrowth and related diarrhea is a condition that frequently accompanies anatomic disorders, surgically created blind loops or strictures with partial small bowel obstruction and although it is often controlled with antimicrobial therapy, alternative treatment may be needed. The aim of this study was to evaluate the efficacy of an oral probiotic preparation of 2 viable lyophilized strains of lactobacilli (1.5 g each) compared with placebo. Twenty two patients with proven overgrowth and chronic diarrhea are described. In random order and double-blind fashion, 2 groups of patients received identical capsules with both Lactobacillus casei and L. acidophillus strains CERELA (12 patients) (LC) and placebo (10 patients) (P) during three consecutive periods of 7 days each followed by a similar three periods of control after withdrawal. At the end of each period the mean daily number of stools, glucose breath H2 test, and symptoms were considered. Lactobacillus were investigated in feces in both groups at day 0 (baseline), on day 21 of treatment with LC and P and on day 21 after withdrawal. Compared with P a significant reduction in mean daily number of stools was achieved with LC (p < 0.005) at 15 days, and (p < 0.0005) at 21 days and the effect was sustained at 7 days and 15 days (p < 0.005) after withdrawal. With respect to breath H2 level a significant decrease in H2 concentration was noted at 7 days (p < 0.005) at 15 days, and 21 days (p < 0.0001) with LC and only a significant decrease (p < 0.005) was observed at 7 days after withdrawal. No significant changes were observed with respect to symptoms. The Lactobacillus CERELA strains were isolated from the feces in all patients LC (n = 12) on day 21, and by contrast no Lactobacillus were observed except in two patients out of seven patients after withdrawal. In summary, this study provides evidence that LC are effective for treatment of bacterial overgrowth--related chronic diarrhea, and suggest that probiotics must be used with continuity. (2)



Probiotic bacteria exhibit a variety of properties, which are unique to a particular strain. Lactobacillus acidophilus-SDC 2012, 2013 are new strains isolated from Korean infants' feces. The potential utility of Lactobacillus acidophilus-SDC 2012, 2013 in irritable bowel syndrome (IBS) was studied. Forty IBS patients were randomized into a placebo (n = 20) and probiotics group (n = 20). Four weeks of treatment with L. acidophilus-SDC 2012, 2013 was associated with a reduced score for abdominal pain or discomfort compared to the baseline (P = 0.011). The percent reduction in abdominal pain or discomfort exceeded the placebo scores by more than 20% (23.8 and 0.2% for probiotics and placebo, respectively, P = 0.003). There was a significant difference in the proportion of responders between the probiotics and placebo groups (P = 0.011). There was no drop out or adverse events for either group during the study period. Lactobacillus acidophilus-SDC 2012, 2013 appeared to have a beneficial effect in patients with IBS. Further studies are warranted. (3)



This review considers whether probiotics are effective agents for the treatment and/or prevention of bacterial vaginosis (BV). There seems to be an association between the absence of, or low concentrations of, vaginal lactobacilli and the development of BV. Many studies have suggested that the presence of H2O2-producing vaginal lactobacilli may protect against BV, although some studies do not support this hypothesis. In-vitro studies have suggested that certain specific strains of lactobacilli are able to inhibit the adherence of Gardnerella vaginalis to the vaginal epithelium and/or produce H2O2, lactic acid and/or bacteriocins, which inhibit the growth of bacteria causing BV. Most clinical trials showed that intra-vaginal administration of Lactobacillus acidophilus for 6-12 days, or oral administration of L. acidophilus or Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 for 2 months, resulted in the cure of BV (defined as a 0-1 positive score according to Amsel's criteria), and/or reduced the recurrences of BV, and/or caused an increase in vaginal lactobacilli and restoration of a normal vaginal microbiota, significantly more frequently than did a placebo, acetic acid or no treatment. (4)



Fatigue and impaired performance in athletes is well recognised and has been loosely linked to "overtraining". Reduced concentration of IgA in the saliva and increased shedding of Epstein Barr virus (EBV) have been associated with intense training in elite athletes. OBJECTIVE: To determine whether athletes presenting with fatigue and impaired performance had an immune defect relevant to defective containment of EBV infection, and whether a probiotic preparation (Lactobacillus acidophilus) shown to enhance mucosal immunity in animal models could reverse any detected abnormality. RESULTS: The fatigued athletes had clinical characteristics consistent with re-activation of EBV infection and significantly (p = 0.02) less secretion of interferon (IFN) gamma from blood CD4 positive T cells. After one month of daily capsules containing 2 x 10(10) colony forming units of L acidophilus, secretion of IFNgamma from T cells had increased significantly (p = 0.01) to levels found in healthy control athletes. A significant (p = 0.03) increase in salivary IFNgamma concentrations in healthy control athletes after the one month course of L acidophilus demonstrated in man the capacity for this probiotic to enhance the mucosal IFNgamma concentration. CONCLUSION: This is the first evidence of a T cell defect in fatigued athletes, and of its reversal following probiotic therapy.  (5)



Two controlled clinical studies were performed to examine effects of consumption of one daily serving of fermented milk (FM) (yogurt) on serum lipids. METHODS: In the first study, subjects were randomly allocated to FM containing Lactobacillus acidophilus L1 of human origin or to FM containing L. acidophilus ATCC 43211 of swine origin. In this single-blind study, subjects consumed one 200 ml serving of FM daily for 3 weeks. The second study was a double-blind, placebo-controlled, cross-over study. Subjects completed a 4-week first treatment, had a 2-week washout, and completed a second 4-week treatment. In the second study subjects consumed FM containing L. acidophilus L1 or placebo FM over 4 weeks. RESULTS: In the first study, FM containing L. acidophilus L1 was accompanied by a 2.4% (p<0.05) reduction of serum cholesterol concentration. In the second study, strain L1 reduced serum cholesterol concentration by 3.2% (p<0.05) in the first treatment period. In the second treatment period there were no significant changes in serum cholesterol concentration. Combined analysis of the two L1 treatment studies demonstrated a 2.8% (p<0.01) reduction in serum cholesterol concentration. CONCLUSION: Since every 1% reduction in serum cholesterol concentration is associated with an estimated 2% to 3% reduction in risk for coronary heart disease, regular intake of FM containing an appropriate strain of L. acidophilus has the potential of reducing risk for coronary heart disease by 6 to 10%.  (6)



Convincing evidence that probiotic administration can lower the risk of antibiotic-associated diarrhoea is limited to certain micro-organisms. AIM: To determine the efficacy of administration of Lactobacillus rhamnosus (strains E/N, Oxy and Pen) for the prevention of antibiotic-associated diarrhoea in children. METHODS: Children (aged 3 months to 14 years) with common infections were enrolled in a double-blind, randomized, placebo-controlled trial in which they received standard antibiotic treatment plus 2 x 10(10) colony forming units of a probiotic (n = 120) or a placebo (n = 120), administered orally twice daily throughout antibiotic treatment. Analyses were by intention to treat. RESULTS: Any diarrhoea (>or=3 loose or watery stools/day for >or=48 h occurring during or up to 2 weeks after the antibiotic therapy) occurred in nine (7.5%) patients in the probiotic group and in 20 (17%) patients in the placebo group (relative risk, RR 0.45, 95% confidence interval, CI 0.2-0.9). Three (2.5%) children in the probiotic group developed AAD (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared to nine (7.5%) in the placebo group (RR 0.33, 95% CI 0.1-1.06). No adverse events were observed. CONCLUSION: Administration of L. rhamnosus (strains E/N, Oxy and Pen) to children receiving antibiotics reduced the risk of any diarrhoea, as defined in this study. (7)



University of Helsinki, Institute of Biomedicine, Pharmacology, PO Box 63, 00014 Helsinki, Finland.

AIM: To evaluate the effects of three potentially anti-inflammatory probiotic bacteria from three different genera on immune variables in healthy adults in a clinical setting based on previous in vitro characterization of cytokine responses. METHODS: A total of 62 volunteers participated in this randomized, double-blind and placebo-controlled parallel group intervention study. The volunteers were randomized to receive a milk-based drink containing either Lactobacillus rhamnosus GG (LGG), Bifidobacterium animalis ssp. lactis Bb12 (Bb12), or Propionibacterium freudenreichii ssp. shermanii JS (PJS) or a placebo drink for 3 wk. Venous blood and saliva samples were taken at baseline and on d 1, 7 and 21. Fecal samples were collected at baseline and at the end of intervention. RESULTS: The serum hsCRP expressed as the median AUC(0-21) (minus baseline) was 0.018 mg/L in the placebo group, -0.240 mg/L in the LGG group, 0.090 mg/L in the Bb12 group and -0.085 mg/L in the PJS group (P = 0.014). In vitro production of TNF-alpha from in vitro cultured peripheral blood mononuclear cells (PBMC) was significantly lower in subjects receiving LGG vs placebo. IL-2 production from PBMC in the Bb12 group was significantly lower compared with the other groups. CONCLUSION: In conclusion, probiotic bacteria have strain-specific anti-inflammatory effects in healthy adults. (8)



Tufts University School of Medicine, Boston, Massachusetts 02111, USA. This email address is being protected from spambots. You need JavaScript enabled to view it.

Probiotic bacteria are used to treat or prevent a broad range of human diseases, conditions, and syndromes. In addition, there are areas of medical use that have been proposed for future probiotic applications. Randomized double-blind studies have provided evidence of probiotic effectiveness for the treatment and prevention of acute diarrhea and antibiotic-induced diarrhea, as well as for the prevention of cow milk-induced food allergy in infants and young children. Research studies have also provided evidence of effectiveness for the prevention of traveler's diarrhea, relapsing Clostridium difficile-induced colitis, and urinary tract infections. There are also studies indicating that probiotics may be useful for prevention of respiratory infections in children, dental caries, irritable bowel syndrome, and inflammatory bowel disease. Areas of future interest for the application of probiotics include colon and bladder cancers, diabetes, and rheumatoid arthritis. The probiotics with the greatest number of proven benefits are Lactobacillus rhamnosus strain GG and Saccharomyces boulardii. (9)


Department of Internal Medicine, Kaohsiung Municipal United Hospital, Kaohsiung, Taiwan, Republic of China.

Evidence suggests that ingesting lactic acid bacteria exerts a suppressive effect on Helicobacter pylori infection in both animals and humans. Supplementing with Lactobacillus- and Bifidobacterium-containing yogurt (AB-yogurt) was shown to improve the rates of eradication of H. pylori in humans. OBJECTIVE: We administered AB-yogurt to subjects with asymptomatic H. pylori to test whether the yogurt could inhibit H. pylori growth. DESIGN: The in vitro inhibition of H. pylori growth was determined by inoculating Lactobacillus acidophilus La5 or Bifidobacterium lactis Bb12 on plates that were inoculated with H. pylori. Assessment of the viability of H. pylori was performed by the mixed culture method with La5 or Bb12. In an intervention study, 59 adult volunteers infected with H. pylori were given AB-yogurt (10(7) colony-forming units of both La5 and Bb12/mL) twice daily after a meal for 6 wk. Eleven subjects positive for H. pylori infection were treated with milk placebo as control subjects. H. pylori bacterial loads were determined with use of the (13)C-urea breath test, which was performed before and 4 and 8 wk after the start of AB-yogurt supplementation. RESULTS: Bb12 exerted an in vitro inhibitory effect against H. pylori, whereas La5 did not show an effect. Administration of AB-yogurt decreased the urease activity of H. pylori after 6 wk of therapy (P < 0.0001). CONCLUSION: Regular intake of yogurt containing Bb12 and La5 effectively suppressed H. pylori infection in humans. (10)



This study was designed to evaluate whether probiotics improve symptoms in patients with irritable bowel syndrome. METHODS: PubMed, Embase, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials were searched for studies that investigated the efficacy of probiotics in the management of irritable bowel syndrome. Clinical improvement was the key outcome of interest. Data were searched within the time period of 1966 through September 2007. RESULTS: Eight randomized, placebo-controlled, clinical trials met our criteria and were included in the analysis. Pooling of eight trials for the outcome of clinical improvement yielded a significant relative risk of 1.22 (95 percent confidence interval, 1.07-1.4; P = 0.0042). CONCLUSIONS: Probiotics may improve symptoms of irritable bowel syndrome and can be used as supplement to standard therapy. (11)