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BioGaia

Protectis Baby Drops

Digestive health in infants and children

Lactobacillus reuteri DSM 17938 infant probiotic drops are clinically effective in preventing and alleviating colic, among other beneficial infant outcomes.

  • Infant Colic Prevention
  • Significantly reduces infant constipation and abdominal pain
  • Prevents infant allergies

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BENEFITS

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CLINICALLY PROVEN;


  • Infant Colic Prevention

  • Super efficiancy over medication Simethicone

  • Significantly reduces infant constipation and abdominal pain

  • Reduces Constipation in pregnancy

  • Prevents infant allergies

  • Reductions in infectious diarrhoea

  • Fewer infant respiratory tract infections

  • Reduced maternal use of antibiotics

  • Less absence from work and day care

  • Reduces antibiotic requirement and antibiotic-associated side effects


INFANT MICROBIOME


The first 1000 days after conception are crucial for the establishment of the intestinal microbiota and immune system maturation. This microbiota plays a central role in health, intervening in key
host metabolic and immunological functions.


Maternal nutrition, health of the microbiota, mode of delivery and antibiotic use are some of the key influencers on establishment of the infant’s microbiota.[7]


LACTOBACILLUS REUTERI DSM 17938


Lactobacillus reuteri DSM 17938 is derived from human mother’s milk. 


It is indigenous to the digestive tract and one of few bacteria that have co-evolved with humans since beginning of time. The microbiota health of the pregnant and breastfeeding mother is important for the establishment of the infant’s gut bacteria. L. reuteri DSM 17938 can promote maternal growth of beneficial bacteria, inhibit pathogens, strengthen mucosal integrity by tightening

the epithelial barrier, and improve the immune response. 


Supplementation has also been shown to reduce common pregnancy complications, such as constipation and gingivitis, while reducing the side effects of antibiotics, which are often prescribed in pregnancy.


REDUCES INFANT AND MATERNAL CONSTIPATION 


More than half of all pregnant women suffer from constipation in pregnancy. Lactobacillus reuteri DSM 17938 modulates gut motility, normalising stool frequency and reduces methane production, which positively affects intestinal transit time[1].


In one clinical trial Lactobacillus reuteri DSM 17938 taken for four weeks significantly reduced methane production, with an approximate 30% increase in bowel movements[1].


PROTECTS AGAINST INFECTIONS


Lactobacillus reuteri DSM 17938 protects against infections A healthy microbiota is essential for a well-functioning immune system for both mother and baby as 80% of the immune system is located in the gastrointestinal tract (GIT).


Lactobacillus reuteri DSM 17938 has antipathogenic and immunomodulatory effects, which makes it more difficult for pathogenic bacteria to grow in the gut. It is a prolific producer of a highly unique antimicrobial substance called reuterin, shown to be effective against multiple pathogens [2].


Studies show that supplementation with this probiotic can lead to:


• Reductions in infectious diarrhoea
• Fewer respiratory tract infections
• Reduced use of antibiotics
• Less absence from work and day care [2]


REDUCED ANTIBIOTIC REQUIREMENT


Antibiotics are among the most widely used drugs in pregnancy. The most common reasons for use are:


• Urinary tract infections (UTIs)
• Respiratory tract infections (RTIs)
• Prophylactic use prior to C-section delivery


Women going through pregnancy and labour are at a greater risk of infections. Since infections like UTIs and postpartum infection may risk the health of both mother and child, affected women are often treated with antibiotics. Antibiotics given to the mother can change bacterial exposure of the foetus before birth, which may result in an unbalanced development of the immune system.


Antibiotic use during pregnancy can cause alterations in the mother’s vaginal microbiota and possible long-term effects on the early microbial colonisation of the child. Probiotic supplementation during pregnancy and early infancy can mitigate this risk.


Research shows Lactobacillus reuteri DSM 17938 reduces the need for antibiotics and successfully reduces antibiotic-associated side effects when used as an adjunct to antibiotic treatment, including:


  • Diarrhoea incidence

  • Abdominal pain

  • Nausea

  • Bloating

  • Constipation


In this clinical trial, 40 subjects took Lactobacillus reuteri DSM 17938 as adjunct to antibiotic therapy for 10 days. Abdominal pain, distension, and defecation disorders and were reduced both during and after antibiotic therapy. [3][4][5]


ENHANCES ORAL HEALTH


Gingivitis is more common in pregnancy and may increase the risk of premature deliveries or low birth weight infants. Streptococcus mutans, a bacterium that can reside in the oral cavity, has been linked with periodontitis and gingivitis. Lactobacillus reuteri DSM 17938 has been shown to inhibit Streptococcus mutans, possibly through the production of the antimicrobial substance reuterin.[6]


PREVENTS INFANT ALLERGIES


Lactobacillus reuteri DSM 17938 have been tested clinically with benefits in allergy symptom prevention and treatment. Research shows that the risk of allergy prevalence may be reduced when probiotics are given to the mother during pregnancy and to the baby from birth and ongoing. This is especially important in pregnant women at high risk of having an allergic child.


Infants born by Caesarean birth do not have direct contact with the mother’s microbiota during the birth and are more likely to develop allergy and asthma later in life. These infants in particular may benefit from support is establishing a health microbiota.


REDUCTION IN INFANT ABDOMINAL PAIN


In a clinical trial Children (age 4-18 years) referred to pediatric gastroenterologist at Children’s Hospital Zagreb from May 2012 to December 2014, diagnosed as FAP or IBS, were randomized to receive L. reuteri DSM 17938 10⁸ CFU daily or placebo. The study was a prospective, randomized, double-blind, placebo-controlled parallel study. Symptoms were evaluated using Wong-Baker FACES pain rating scale for pain and Bristol scale for stool shape and consistence.[9]


Data were analyzed for 55 children (26 in the intervention group and 29 in the placebo group). Children in the intervention group had significantly more days without pain (median 89.5 vs 51 days, P = 0.029). Abdominal pain was less severe in children taking probiotics during the second month (P < 0.05) and fourth month (P < 0.01).[9]


REDUCTION IN INFANT CONSTIPATION


A double-blind, placebo-controlled, randomized study was conducted from January 2008 to December 2008 in 44 consecutive infants at least 6 months old (mean age+/-SD, 8.2+/-2.4 SD; male/female, 24/20) admitted to the Gastrointestinal Endoscopy and Motility Unit of the Department of Pediatrics, University “Federico II” of Naples, with a diagnosis of functional chronic constipation. The 44 infants with chronic constipation were randomly assigned to 2 groups: group A (n=22) received supplementation with the probiotic L. reuteri (DSM 17938) and group B (n=22) received an identical placebo. Primary outcome measures were frequency of bowel movements per week, stool consistency, and presence of inconsolable crying episodes, recorded in a daily diary by parents.[10]


Infants receiving L. reuteri (DSM 17938) had a significantly higher frequency of bowel movements than infants receiving a placebo at week 2 (P=.042), week 4 (P=.008), and week 8 (P=.027) of supplementation. In the L. reuteri group, the stool consistency was reported as hard in 19 infants (86.4%) at baseline, in 11 infants (50%) at week 2, and in 4 infants (18.2%) at weeks 4 and 8.[10]


INFANT COLIC PREVENTION


A prospective, multicenter, double-masked, placebo-controlled randomized clinical trial was performed on term newborns (age <1 week) born at 9 different neonatal units in Italy between September 1, 2010, and October 30, 2012. Parents were asked to record in a structured diary the number of episodes of regurgitation, duration of inconsolable crying (minutes per day), number of evacuations per day, number of visits to pediatricians, feeding changes, hospitalizations, visits to a pediatric emergency department for a perceived health emergency, pharmacologic interventions, and loss of parental working days. In total, 589 infants were randomly allocated to receive L. reuteri DSM 17938 or placebo daily for 90 days. The primary outcome was to evaluate the Reduction of daily crying time, regurgitation, and constipation during the first 3 months of life. Secondary outcomes included a cost-benefit analysis of the probiotic supplementation.[11]


At 3 months of age, the mean duration of crying time (38 vs 71 minutes; P < .01), the mean number of regurgitations per day (2.9 vs 4.6; P < .01), and the mean number of evacuations per day (4.2 vs 3.6; P < .01) for the L. reuteri DSM 17938 and placebo groups, respectively, were significantly different.[11]


EFFECIENCY OVER MEDICATION SIMETHICONE

Ninety breastfed colicky infants were assigned randomly to receive either the probiotic L. reuteri (108) live bacteria per day) or simethicone (60 mg/day) each day for 28 days. The mothers avoided cow’s milk in their diet. Parents monitored daily crying times and adverse effects by using a questionnaire.[12]


Eighty-three infants completed the trial: 41 in the Lactobacillus reuteri probiotic group and 42 in the simethicone group. The infants were similar regarding gestational age, birth weight, gender, and crying time at baseline. Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day, respectively, on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day. On day 28, 39 patients (95%) were responders in the probiotic group and 3 patients (7%) were responders in the simethicone group.[12]

INGREDIENTS

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Item

Description

Item

Description

DIRECTIONS

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Infant / Children: 

Shake well for 10 seconds before each use. 

Tilt the bottle and dispense 5 drops into formula / into a syringe / or onto a spoon and deliver to your child’s mouth.

EVIDENCE

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References


[1] Ojetti V, Petruzziello C, Migneco A, et al. 2017. Effect of Lactobacillus reuteri (DSM 17938) on methane production in patients affected by functional constipation: A retrospective study. Eur Rev Med Pharmacol Sci. 21(7):1702-8.

[2] Walter J, et al. Proc Natl Acad Sci U S A. 2011;108: 4645-4652. 4. Valeur N, et al. Appl Environ Microbiol. 2004;70: 1176-1181.

[3] Stokholm J, et al. (2013) Prevalence and Predictors of Antibiotic Administration during Pregnancy and Birth. PLoS ONE 8(12): e82932; Gyte GM et al. Cochrane Database of Systematic Reviews 2014, Issue 11. Art. No.: CD008726; Lionetti E, Miniello VL, Castellaneta SP et al. 2006. 

[4] Lactobacillus reuteri therapy to reduce side-effects during anti- Helicobacter pylori treatment in children: a randomised placebo-controlled trial. Aliment Pharmacol Ther. 24:1461-1468.; Weizman
Z, Asli G, Alsheikh A. 

[5] Effect of a probiotic infant formula on infections in child care centers: comparison of two probiotic agents. Pediatrics. 2005 Jan 1;115(1):5-9; Gutierrez-Castrellon P, et al. Diarrhea in preschool children and Lactobacillus reuteri: a randomized controlled trial. Pediatrics. 2014 Apr 1;133(4):e904-9.

[6] Wu, M et al (2015). Mediators Inflamm 2015, 623427; Ide M et al (2013). J Clin Periodontol 2013; 40 (Suppl. 14): S181–S194; Dani S, et al. Assessment of Streptococcus mutans in healthy versus gingivitis and chronic periodontitis: A clinico- microbiological study. Contemporary clinical dentistry. 2016 Oct;7(4):529.

[7] Adapted from: Indrio F, Martini S, Francavilla R, Corvaglia L, Cristofori F, Mastrolia SA, Neu J, Rautava S, Russo Spena G, Raimondi F, Loverro G. Epigenetic matters: the link between early nutrition, microbiome, and long-term health development. Frontiers in Pediatrics. 2017 Aug 22;5:178.

[8] Zuccotti G, et al. Probiotics for prevention of atopic diseases in infants: systematic review and meta‐analysis. Allergy. 2015 Nov;70(11):1356-71; Cuello-Garcia, C.A., et al. 2015. Probiotics for the prevention of allergy: a systematic review and meta- analysis of randomized controlled trials. Journal of Allergy and Clinical immunology, 136(4), pp.952-961; Fiocchi A, et al. World Allergy Organization-McMaster university guidelines for allergic disease prevention (GLAD-P): probiotics. World Allergy Organization Journal. 2015 Dec;8(1):1; Neu J, Rushing J. Cesarean versus vaginal delivery: long-term infant outcomes and the hygiene hypothesis. Clinics in perinatology. 2011 Jun 1;38(2):321-31.

[9] Jadrešin O, Hojsak I, Mišak Z, Kekez AJ, Trbojević T, Ivković L, Kolaček S. J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):925-929

[10]  Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. Coccorullo P, Strisciuglio C, Martinelli M, Miele E, Greco L, Staiano A. J Pediatr. 2010 Oct;157(4):598-602.

[11] Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. JAMA Pediatr. 2014 Mar;168(3):228-33.

[12] Lactobacillus reuteri ATCC 55730 versus simethicone in the treatment of infantile colic: a prospective randomized study. Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Journal: Pediatrics. 2007 Jan;119(1):e124-30.

WARNINGS

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Use only as directed

BQBGPBD

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