Clinical Research

An essential resource for Lactobacillus LB publications and developments.

Publications about Lactéol®

The active ingredient of Lactéol® is heat - treated Lactobacillus LB and its culture medium. Lactéol® is one of the most scientifically well documented micro - organism based therapeutics in the world regarding both efficacy and safety. In the past 30 years well over 50 articles describing Lactobacillus LB have been published in peer - reviewed scientific journals.

Lactéol® research and publications

  • Well over 40 primary research and clinical studies have been published supporting the use of Lactéol®
  • There is over 100 years of clinical experience with Lactéol® (it was first marketed in 1907)

The information set out below is a description of a select group of well - designed randomised controlled trials that have been conducted in adults and children with Lactéol®. These studies demonstrate Lactéol®’s efficacy and safety in a variety of diarrhea subtypes in both adult and paediatric patients.

Yap Soo Kor JA, et al. Lacteol® Fort treatment reduces antibiotic associated diarrhea. Singapore Fam Physician 2010;34:46-9

Background

Exploratory study on the effect of Lactéol® on antibiotic - associated bowel disturbances in a primary care population.

Methods

Consecutive patients attending a primary care clinic, as a result of infection and who were prescribed antibiotics, were recruited prospectively. All patients seen by one of the attending physicians were prescribed antibiotics without Lactéol® (antibiotic only) (n=96, 29% male, mean age 38 years). All patients seen by a second attending physician were prescribed 2 Lactéol® capsules twice daily for one week during the antibiotic treatment course (antibiotic + Lactéol®) (n=88, 43% male, mean age 36.4 years). Healthy patients attending the annual health screening from the same centre (n=141, 23% male, mean age 39.7 years) were enrolled in the study as healthy controls. All subjects completed a structured questionnaire at entry, and kept a bowel diary for two weeks from the start of treatment.

Results

Conclusions

These results suggest that Lactéol® treatment may reduce the risks of diarrhea associated with antibiotic treatment.

Xiao SD, et al. Multicentre, randomized, controlled trial of heat - killed Lactobacillus acidophilus LB in patients with chronic diarrhea. Adv Ther 2003;20:253-60

Background

Chronic diarrhea is a common bowel disorder; disturbance of intestinal microorganisms may play a role in its pathogenesis. This study assessed the clinical efficacy of lyophilized, heat - killed Lactobacillus acidophilus LB [Lactéol®] versus living lactobacilli [Lacidophilin®] in the treatment of chronic diarrhea.

Methods

One hundred thirty - seven patients with chronic diarrhea were randomly allocated to receive either a 4 - week course of 2 capsules of Lactéol® twice a day* (Lactéol® group, 69 patients) or a 4 - week course of 5 chewable tablets of Lacidophilin® [probiotic] three times a day (Lacidophilin® group, 64 patients). The frequency of stools was recorded quantitatively, and semi - quantitative parameters such as stool consistency, abdominal pain, distention, and feeling of incomplete evacuation were evaluated.

Results

Conclusions

At the ends of the treatment, the clinical symptoms were markedly improved in the Lactéol® group, indicating that L. acidophilus LB is more effective than living lactobacilli in the treatment of chronic diarrhea.

*Each capsule contains 5 billion L. acidophilus (LB strain from human origin) that have been heat - killed and lyophilized in the presence of fermented culture medium (80 mg).

Tarrerias AL, et al. The effect of inactivated Lactobacillus LB fermented culture medium on symptom severity: observational investigation in 297 patients with diarrhea - predominant irritable bowel syndrome (IBS). Dig Dis 2011;29:588-91

Background

Little is known about the intensity of symptoms of diarrhea - predominant IBS or the consequences of the disease on patients’ health - related quality of life (HRQOL). This observational investigation assessed the symptoms (abdominal pain, bloating, number of stools per day, and stool consistency), impact on HRQOL, and consequence on anal continence in 297 patients with IBS before and after 1 month of treatment with Lactéol® (inactivated Lactobacillus LB plus fermented culture medium).

Methods

Functional assessment using a standardized visual analogue scale in order to quantify abdominal pain, bloating, and quality of life before and after 1 month of treatment with 2 capsules/day of Lactéol®. The number of symptomatic days per week, number of stools, consistency of stools, secondary faecal incontinence rate, and potential trigger effect of food were quantified. A χ2 test was used to compare qualitative data and the variance of quantitative criteria was analysed.

Results

Conclusions

This observational investigation shed new light on patients with IBS - D, the HRQOL of which is altered by a faecal incontinence rate twice as high as that of the general population. Correlation with diet is confirmed by 1 out of 2 patients reporting poor tolerance of fibre and dairy products. Nutritional management should thus be part of these patients’ treatment. Inactivated Lactobacillus LB plus fermented culture medium is a postbiotic drug that has been used by physicians for a long time to treat patients with diarrhea. Strongly concentrated, it has no side effects and seems to help these patients. Due to a strong placebo effect in patients with this pathology, however, a controlled study is necessary to confirm this result.

Simakachorn N, et al. Clinical evaluation of the addition of lyophilized, heat - killed Lactobacillus acidophilus LB to oral rehydration therapy in the treatment of acute diarrhea in children. J Pediatr Gastroenterol Nutr 2000;30:68-72

Background

In this trial, the clinical efficacy of a medication (Lactéol® sachets) containing lyophilized heat - killed Lactobacillus acidophilus LB* [Lactéol®] was assessed as an adjunct to oral rehydration therapy.

Methods

Children aged 3 to 24 months with acute diarrhea and mild or moderate dehydration were enrolled in the study. Children received oral rehydration therapy for the first 4 hours. After this first rehydration phase, undiluted milk formula or breast milk was fed alternately with oral rehydration solution. Children were fed rice gruel as tolerated. They received either one sachet containing 10 billion lyophilized heat - treated L. acidophilus LB or placebo at admission and at 12 - hour intervals for five doses.

Results

Conclusions

Addition of L. acidophilus LB to oral rehydration therapy was effective in the treatment of children with acute diarrhea by decreasing the duration of diarrhea.

*The children received either 2 x 1010 bacteria/day (sachets of 10 billion lyophilized and heat - killed L. acidophilus LB and 160 mg of fermented lyophilized culture medium) or placebo.

Salazar-Lindo E, et al. Effectiveness and safety of Lactobacillus LB in the treatment of mild acute diarrhea in children. J Pediatr Gastroenterol Nutr 2007;44:571-6

Background

Acute diarrhea is an important cause of morbidity and mortality in children. Oral rehydration salts (ORS) have lowered mortality without having an effect on the duration or severity of diarrhea. Some studies have reported that heat - killed Lactobacillus bacteria have a beneficial effect in the treatment of acute diarrhea. In this placebo - controlled study the duration of diarrhea was compared for 2 types of treatment: Lactobacillus LB (Lactéol®) in association with oral rehydration and oral rehydration alone.*

Methods

A total of 80 non - dehydrated children between the ages of 3 months and 4 years with acute watery diarrhea were randomly assigned to be treated with Lactobacillus LB or placebo plus ORS. The primary endpoint was the duration of diarrhea; intake of ORS and change in body weight between the time of randomization and the last assessment were also measured.

Results

Conclusions

Lactobacillus LB is an effective and safe treatment for children with well - established diarrhea (>24 h).

*Children received an initial dose of 2 sachets of placebo or Lactobacillus LB and continued treatment at home with 1 sachet every 12 hours for 4.5 days (10 sachets on completed treatment). The active treatment administered was Lactéol® 340 mg powder for oral suspension in single sachet doses. Each patient in the treatment group received 20 billion units of heat - treated Lactobacillus LB strain and 320 mg of neutralized supernatant spent culture medium per day (in sachets containing 10 billion microbes each).

Liévin-Le Moal V, et al. An experimental study and a randomized, double-blind, placebo-controlled clinical trial to evaluate the antisecretory activity of Lactobacillus acidophilus strain LB against non-rotavirus diarrhea. Pediatrics 2007;120:e795-803

Background

Previous studies have shown that selected strains of Lactobacillus have the capacity to antagonize rotavirus - induced diarrhea. However, only a few reports have documented their efficacy against non - rotavirus diarrhea. This study involved an experimental investigation and a clinical trial of the antisecretory activity of Lactobacillus acidophilus strain LB [Lactéol®] in the context of non - rotavirus diarrhea.

Methods

The activity of a culture of L. acidophilus LB or of the lyophilized, heat - treated L. acidophilus LB bacteria plus their spent culture medium was tested in inhibiting the formation of fluid – formed domes in cultured human intestinal Caco - 2/TC7 cell monolayers infected with diarrheagenic, diffusely adhering Afa/Dr Escherichia coli C1845 bacteria. A randomized, double – blind, placebo – controlled clinical trial of male or female children who were 10 months of age and presented with non - rotavirus, well – established diarrhea was conducted to evaluate the therapeutic efficacy of a pharmaceutical preparation that contains 10 billion heat – treated L. acidophilus LB plus 160 mg of spent culture medium.*

Results

Conclusions

Heat - treated L. acidophilus LB plus its culture medium (Lactéol®) antagonizes the C1845 - induced in paracellular permeability in intestinal Caco - 2/TC7 cells and produces a clinically significant benefit in the management of children with non - rotavirus, well established diarrhea.

*Patients received Lactéol® sachets, each sachet containing 10 billion heat - treated L. acidophilus LB plus 160 mg of spent culture medium; at an initial dose of 2 sachets and subsequently 1 sachet every 12 hours, with a total of 8 sachets ingested between meals.

All the above studies may not have been included in the marketing authorization application in all the countries where Lactéol® is registered.

  1. Yap Soo Kor JA, Gwee Kok A, Chen ZA, Tai Bee Choo A, Wong Mee L. Lacteol® Fort treatment reduces antibiotic associated diarrhea. Singapore Fam Physician 2010;34:46-9.
  2. Xiao SD, Zhang DZ, Lu H, et al. Multicenter, randomized, controlled trial of heat-killed Lactobacillus acidophilus LB in patients with chronic diarrhea. Adv Ther 2003;20:253-60.
  3. Tarrerias AL, Costil V, Vicari F, et al. The effect of inactivated Lactobacillus LB fermented culture medium on symptom severity: observational investigation in 297 patients with diarrhea-predominant irritable bowel syndrome. Dig Dis 2011;29:588-91.
  4. Simakachorn N, Pichaipat V, Rithipornpaisarn P, Kongkaew C, Tongpradit P, Varavithya W. Clinical evaluation of the addition of lyophilized, heat-killed Lactobacillus acidophilus LB to oral rehydration therapy in the treatment of acute diarrhea in children. J Pediatr Gastroenterol Nutr 2000;30:68-72.
  5. Salazar-Lindo E, Figueroa-Quintanilla D, Caciano MI, Reto-Valiente V, Chauviere G, Colin P. Effectiveness and safety of Lactobacillus LB in the treatment of mild acute diarrhea in children. J Pediatr Gastroenterol Nutr 2007;44:571-6.
  6. Liévin-Le Moal V, Sarrazin-Davila LE, Servin AL. An experimental study and a randomized, double-blind, placebo-controlled clinical trial to evaluate the antisecretory activity of Lactobacillus acidophilus strain LB against nonrotavirus diarrhea. Pediatrics 2007;120:e795-803.

UPCOMING EVENTS

Selected international conferences and congresses in the near future covering ‘biotics’ and the microbiome are listed here…

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