Frequently Asked Questions
Some commonly asked questions about Lactéol® are addressed here. Further information can be found in the Lactéol® Summary of Product Characteristics or the Prescribing Information. Package labelling and indications may differ between countries.
The WHO defines probiotics as live microorganisms which when administered in adequate amounts confer a health benefit on the host.1 Lactéol®’s active ingredients are freeze - dried, heat - treated Lactobacillus LB and its cell culture supernatant. Lactéol® is a postbiotic because the micro - organisms have been heat - treated.2
Lactéol® has been shown in clinical studies to be effective and well tolerated in both children and adults for the treatment of any type of diarrhea of any cause.3-5
The mechanisms of action of live and inactivated micro - organisms (such as heat – treated micro – organisms) are different.6 The efficacy of Lactéol® does not depend on the viability of the cells. lts efficacy is based on the active microbial components. lnactivated micro – organisms and cell culture supernatants contain fragments of cellular structures and liberated bacterial secretions. These are capable of crossing both the outer and the inner mucosal layers and can directly stimulate the epithelial cells.6 As the cellular fragments and metabolites released by the heat – treatment of postbiotics gradually cross the mucosal layers, they tend to accumulate on the apical side, reinforcing the barrier’s integrity.6
Lactéol® can be prescribed for both adults and children with diarrhea. Lactéol® should be taken as soon as possible after the start of diarrhea; rehydration and/or dietary measures should also be initiated. The dosage of 1 to 2 sachets or capsules should be adjusted according to the intensity of the diarrhea, with the possibility of taking up to 3 sachets or capsules on the first day of treatment. *8,9
* Dosage for the 340 mg capsules and sachets.8,9 For 170 mg the dosage is 2 to 4 capsules per day, based on the intensity of the condition and may be increased to 6 capsules on the first day of treatment.7
Yes. Lactéol® is indicated to be given as an adjunct to oral rehydration and/or dietary measures.7-9
Yes. Lactéol® demonstrated to reduce the risk of diarrhea in patients taking antibiotic therapy.3
Yes. Lactéol® has been shown to be effective for both rotavirus - associated and non - rotavirus diarrhea.4,5 When administered of with oral rehydration and/or dietary measures it reduces the frequency and increases the consistency of stool.4,5
Lactéol® has been designed for use by the whole family, from the very young to the very old. Lactéol® is formulated as 340 mg and 170 mg capsules for children over 6 and for adults. Lactéol® is also available as 340 mg sachets for dispersion in water to allow those under the age of 6 to be able to take it more easily. 7-9
Lactéol® is unique because it is the first postbiotic with clinically demonstrated efficacy and safety that is suitable for the whole family, from the youngest to the oldest.7-9 Lactéol® has unique properties. The unique bacterial species in Lactobacillus LB are registered and stored at the Pasteur Institute in Paris, and are owned by Adare. Lactéol® is manufactured in France to certified pharmaceutical production standards. The production process is also proprietary technology. Lactéol®’s unique composition offers effective treatment of diarrhea with the benefits of being heat – treated.
Lactéol® has a good safety profile.7-9 ln its decades of wide use and many clinical studies, no serious events have been reported with regards to Lactéol®.3,4,10-12 Moreover, due to the absence of potential drug interactions, Lactéol® can be taken concomitantly with other treatments.
There are no serious side effects reported with Lactéol®, however some potential allergic reactions have been reported as a possible reaction to excipients.7-9 Lactéol® is made from heat - treated Lactobacillus species that are already present in the human microbiota and a reduced risk of side effects would be expected. Hypersensitivity reactions and urticaria have been reported as part of the pharmacovigilance program. Lactéol® contains lactose, it should not be used by patients with a history of allergy to cow milk proteins or with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare metabolic diseases).7-9
Lactéol® contains freeze - dried, heat - treated Lactobacillus LB and its fermented culture medium (fermentation supernatant), so it is very stable and can be taken with hot or cold drinks without any effect on its efficacy.
The Lactobacillus LB and culture supernatant in Lactéol® have been heat - treated, which affords them a very high degree of stability, thus no special refrigeration for storage or transport is required. Provided the packaging remains unopened, Lactéol® can be stored at room temperature (below 25°C) until its expiry date.7-9
- Hill C, Guarner F, Reid G, et al. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol 2014;11:506-14.
- Wegh CAM, Geerlings SY, Knol J, Roeselers G, Belzer C. Postbiotics and their potential applications in early life nutrition and beyond. Int J Mol Sci 2019;20.
- 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.
- 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.
- 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.
- Piqué N, Berlanga M, Miñana-Galbis D. Health benefits of heat-killed (tyndallized) probiotics: an overview. Int J Mol Sci 2019;20.
- Lactéol® 170 mg capsules. Summary of Product Characteristics. Houdan, France: Adare Pharmaceuticals; 2017.
- Lactéol® 340 mg capsules. Summary of Product Characteristics. Houdan, France: Adare Pharmaceuticals; 2017.
- Lactéol® 340 mg sachets. Summary of Product Characteristics. Houdan, France: Adare Pharmaceuticals; 2017.
- 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.
- Salgado AJ, Garcia Jara JA. Treatment with Lactéol® Fort of adults suffering from acute diarrhea in Mexico. Rev Hosp Mujer 1993;2:61-3.
- 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.
ADARE BIOME, WORLD - CLASS EXPERTISE IN POSTBIOTICS
Adare Biome is a specialty division of Adare Pharma Solutions dedicated to harnessing the power of the microbiome. Adare Biome is located in Houdan, near Paris France, and for many decades has used its proprietary fermentation processes and expertise in the development of microbiome therapeutics …