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BioGaia

Protectis Chewable

Probiotic for Constipation

Protectis contains the clinically trialled strain, L. reuteri DSM 17938, proven effective for alleviating constipation, pain and bloating.

  • Alleviates constipation
  • Reduces abdominal pain and bloating
  • Infant Colic Prevention

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BENEFITS

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CLINICALLY PROVEN;


DIGESTIVE HEALTH


  • Alleviates constipation

  • Reduces abdominal pain and bloating 


PREGNANCY


  • Infant Colic Prevention

  • 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]


CONSTIPATION 


A double-blind, placebo RCT was conducted in 40 adults (18M/22F, 35+/-15 years) affected by functional constipation according to the Rome III criteria. Patients were randomly assigned to receive a supplementation of L. reuteri (DSM 17938), or matching placebo for 4 weeks. The increase of bowel movements/week was the primary outcome, while the improvement of stool consistency was the secondary outcome.[12]


At week 4, the mean increase in bowel movements/week was 2.6 (SD +/-1.14, 95% CI:1.6-3.6) in the L. reuteri group and 1.0 (SD+/-1. 95% CI:0.12-1.88) in the placebo group (p=0.046). At the end of the treatment, the mean bowel movements/week was 5.28+/-1.93 in the L. reuteri group and 3.89+/-1.79 in the placebo group. There was a not significant difference in the stool consistency between the two groups.[12]


REDUCES ABDOMINAL PAIN AND BLOATING 


In another clinical trial L. reuteri DSM 17938 was administered for 105 days in a randomised double-blind clinical trial (28 patients per arm). Individual and cumulative scores including the Constipaq, a modified Constipation Scoring System (CSS) that considers the patient assessment of constipation-QoL (PAC-QoL), were calculated during the preliminary visit (V0), at day 15 (end of the induction period with a L. reuteri DSM 17938 double dosage, 4×108 cfu), day 60 (intermediate evaluation) and day 105 (V4) after a standard dosage (2×108 CFU).[13]


At the end of treatment, the beneficial effect of L. reuteri DSM 17938 compared to placebo was significantly evident for symptoms related to gas content and dysbiosis (abdominal discomfort, pain and bloating), incomplete defecation and helps for defecation (P<0.05). At the end of the whole L. reuteri DSM 17938 treatment, a marked and positive effect on both the CSS single and the cumulative items was evident with the exception of unfruitful attempt and Bristol score.[13]

INGREDIENTS

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DIRECTIONS

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Adults:
Adults and children: chew 1-2 tablets daily, with meals

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] The effect of Lactobacillus reuteri supplementation in adults with chronic functional constipation: a randomized, double-blind, placebo-controlled trial. Ojetti V, Ianiro G, Tortora A, D'Angelo G, Di Rienzo TA, Bibbò S, Migneco A, Gasbarrini A. J Gastrointestin Liver Dis. 2014;23(4):387-91

[13] Randomised double blind placebo controlled trial on Lactobacillus reuteri DSM 17938: improvement in symptoms and bowel habit in functional constipation. Riezzo G, Orlando A, D'Attoma B, Linsalata M, Martulli M, Russo F. (2018). Journal: Benef Microbes. 2018;9:51-60.

WARNINGS

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Use only as directed

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