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NEW: Published in August 2022, a randomised, double-blinded and placebo-controlled study in 200 premature babies demonstrated that, in the group who received Labinic Drops, there were no cases of NEC and feed tolerance significantly improved. Full text PDF link here. or Full text open access article link here.
Previous meta-analyses of studies of over 19,000 babies have consistently shown a substantial reduction in necrotising enterocolitis, mortality and Late onset sepsis in premature babies recieving multistrain probiotics. A recent review showed a significant reduction in NEC and mortality in a UK NICU using Labinic Drops. Labinic has been used even in the most premature babies (22 weeks onwards) due to its excellent safety profile.
There are 3 strains of probiotics present in equal quantities in Labinic Drops. 0.2ml provides 2 billion probiotic bacteria of:
Labinic Drops are not classified as medicines in the UK/EU and in some other jurisdictions. In others they have an intermediate classification. Labinic Drops are classified as food supplements with no health claims permitted.
Labinic Drops are manufactured to pharmaceutical standards in specialised probiotic-only facilities. This is far more stringent than normal dietary supplement manufacturing.
- Facilities: Our new production facilities meet the international standards of Good Manufacturing Practice (GMP) and Good Pharmacy Practice (GPP) and are rated A-grade as a manufacturing pharmacy.
- Quality Control: Every batch undergoes pre- and post-production quality checks, to verify that they meet strict quality and safety standards. This is supervised by a Pharmacist and a Microbiologist.
- Contaminant checks: Labinic is manufactured in positive-pressure clean-room conditions. Full bacterial and fungal contaminant monitoring is carried out and available for every batch.
- Live strain viability counts: Certificates of Compliance and Certificates of Analysis are produced for every batch. This includes live counts at time of manufacture. In addition, we have conducted 2 year stability testing, at different environmental temperatures. The live CFU count at the end of shelf-life meets the Conformance Standards.
Exposure to antibiotics (either at Caesarean Section, through breast milk or from courses of antibiotics) can cause intestinal dybiosis (disruption of the normal healthy gut microbiome) in babies. In addition, antacids (e.g. gaviscon, omeprazole, lanzoprazole) can also cause dysbiosis. This may cause reflux, abdominal pain, excessive/painful wind, diarrhoea and/or mucousy stools.
Labinic Drops can help to correct a dysbiosis and assist in the restoration of a more normal microbiome, with subsequent resolution of symptoms.
Labinic Drops represent great value. Labinic is manufactured to pharmaceutical standards and provides 2 billion probiotics for a very low daily price. How do we do it?
The costs of NEC are substantial worldwide. In the USA, Johnson et al estimated the cost of medical NEC at $43-74,000 and surgical NEC (occuring 30% of cases) at $138-220,000, with the cost of short bowel syndrome over 5 years costing $1.5million per patient.
In the UK as an example, the estimated costs are lower: surgical NEC is £54-71,000 per patient, and medical NEC is £21-37,000 (Renfrew et al). In 2013 575 cases of surgical NEC cost about £33m (ONS). The costs of sepsis are lower but significant. It is possible to assign costs of mortality and disability based on lost QALYs.
Based on the meta-analysis reductions in NEC, mortality and sepsis, we estimate that if every premature baby born in the NHS (UK) at less than 34 weeks was given Labinic Drops once they had started milk feeds, and that Labinic was continued until 37 weeks corrected gestation, then the NHS could save £20 million every year (including the cost of the Labinic Drops).
None of this includes the suffering and distress caused by these potentially modifiable conditions.
Live bacterial preparations such as Labinic Drops should be handled and used with sensible precautions and care. Whilst they are generally recognised as safe, there are rare reported cases of infections arising from use of probiotics particularly in immunocompromised individuals, such as extremely preterm babies and patients receiving immune suppressants, patients with damaged intestinal tract (e.g. intestinal perforations and necrotising enterocolitis) where the live bacteria can enter the blood stream.
No reports of infections have been reported from the use of Labinic Drops, and over 1.5 million doses have to date (2020) been given.
In any patient who becomes unwell who is receiving Labinic Drops, the administration should be ceased immediately and appropriate investigations and treatment commenced. Labinic bacteria would normally be sensitive to combinations of Penicillin/Gentamicin, Ampicillin/Gentamicin, Meropenem/Vancomycin, Piptazobactam/Vancomycin, Cefotaxime/Vancomycin although the advice of a Pharmacist and Microbiologist should always be sought.
United Kingdom NHS and private distribution of Labinic Drops in the UK is currently directly provided by Biofloratech Ltd
Ireland Labinic Drops are available from our distribution partner MedFind Solutions
Australia and New Zealand Labinic Drops are available from our distribution partner Medsurge in Australia and New Zealand.
Southern Africa Labinic Drops are available from our distribution partner Safeline in Southern Africa.
Middle East and Hong Kong Labinic Drops are available from our distribution partner Miller and Miller.
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