Oral lactase for infantile colic: a randomized double-blind placebo-controlled trial.

BACKGROUND: Infantile colic is a common problem during the first three months of life. This randomized, double-blind, placebo-controlled trial conducted in an urban hospital in Delhi, India evaluated the efficacy and safety of oral lactase in management of infantile colic. METHODS: One hundred sixty-two clinically healthy infants aged < 5 months age [mean (SD) = 63.5 (30.5) days] fulfilling the Rome-IV diagnostic criteria for infantile colic were enrolled. Eligible children were randomly allocated to receive 5 drops of lactase (600 FCC units/mL) (n = 80) or placebo (n = 82) mixed with breast milk or formula feed four times a day for a duration of 4 weeks. Primary outcomes were duration of crying or fussing (min/d), and number of days with colic lasting > 3 h/d; secondary outcomes were parental satisfaction and adverse events. RESULTS: At the end of four weeks, mean (SD) crying or fussing time (min/d) was significantly shorter in infants receiving lactase in comparison to placebo [89.9 (115.2) vs.178.5 (153.2); P = 0.001]. The mean (SD) number of days with colic was also significantly less in the lactase group as compared to placebo group at the end of the treatment [12.1 (7.8) vs 17.6 (8.4); P < 0.001]. By the end of 4th week, parental satisfaction in terms of infant's mood, activity, alertness, comfort and oral intake was better in intervention group. The adverse event profile was comparable between two groups. CONCLUSIONS: Oral lactase treatment in infantile colic results in symptomatic relief in terms of shortening of duration of crying or fussing, and better parental satisfaction. TRIAL REGISTRATION: Clinical trial registry of India (CTRI/2017/12/010930) registered on 20/12/2017.

Treatment of lactase deficiency in children's obesity with genotype c/c 13910 of lactase gene.

OBJECTIVE: Introduction: Excess lactose in the diet of modern man causes the development of not only lactase deficiency, but it can be a factor that contributes to obesity. The aim: To study associations between obesity and genotype C/C 13910 of lactase gene (LCT) in children, to investigate the effectiveness of treatment using drug exogenous lactase and a low-lactose diet. PATIENTS AND METHODS: Materials and methods: genotyping of lactase gene by real-time polymerase chain reaction, determining the level of lactose maldigestion by hydrogen breath test (HBT), estimating the insulin resistance with the HOMA-IR index in 70 obese children and 40 healthy children 6 - 18 years. Obese children with genotype C/C 13910 and lactose maldigestion (n=40) were randomized in two groups: children from group I (n=20) received an exogenous lactase preparation, and children from group II (n=20) - low-lactose diet. RESULTS: Results: in obese children, the genotype C/C 13910 is 2 times more often than in healthy children. Obese children with genotype C/C 13910 have a significantly higher value of HBT (32.8-39.8 ppm) compared to healthy children (p<0.05), and an increased value of the HOMA-IR index. After treatment, there was a significant decrease in HBT and the HOMA-IR index in the two comparison groups. CONCLUSION: Conclusions: signs of insulin resistance are observed in children with obesity, genotype C/C 13910 and lactose maldigestion. The use of exogenous lactase in the therapy or the administration of a low-lactose diet cause approximately the same decrease in the HOMA-IR index.

Clinical Efficacy Of Lactase Enzyme Supplement In Infant Colic: A Randomised Controlled Trial.

OBJECTIVE: To determine the efficacy of lactase enzyme supplement in infant colic. METHODS: The double-blind randomised clinical trial was conducted from November 2014 to June 2017 at Kharadar General Hospital, Karachi, and comprised infants aged 0-6 months with infant colic, excessive crying lasting at least 3 hours a day on at least 3 days a week for at least 3 weeks. The subjects were randomised into intervention group A which received lactase enzyme Colibid, and placebo group B. Five drops of intervention preparation were received by all the infants before each feed for two weeks. Confidentiality of active agent and placebo was maintained through drug codes. The duration of crying was recorded at baseline then after first and second weeks of intervention. The two groups were compared with level of significance set at p<0.05. RESULTS: There were 104 subjects with 52(50%) in each of the two groups Overall, 50(48.1%) were boys. At baseline, all (100%) the subjects had infant colic or excessive crying. After two-week intervention, significant improvement was seen in the duration of crying in group A 45(86.5%) compared to group B 31(59.6%) (p<0.05). CONCLUSIONS: Significant improvement was seen in the duration of crying in infants who received lactase enzyme supplement..

Diagnostic algorithm and peculiarities of monitoring for infants with disorders of the gastrointestinal tract.

INTRODUCTION: The most common medical conditions in infants, which belong to pediatric and gastroenterological disease areas, are functional gastrointestinal disorders, food hypersensitivity and food allergy. First of all, these symptoms can disguise lactase deficiency, cow's milk protein allergy, eosinophilic gastroenteritis, allergic proctocolitis, gastrointestinal manifestations of atopic dermatitis, functional disorders of gastrointestinal and biliary tract, etc. The aim of our study was to develop an algorithm of monitoring for infants with disorders of the gastrointestinal tract and to study the efficacy of probiotic and enzyme replacement therapy. Materials and metods: 47 children aged 1 to 3 years with gastrointestinal and atopic dermatitis symptoms underwent clinical and laboratory examinations. RESULTS: Analysis of additional examination revealed the causes of gastrointestinal disorders, and the following diagnoses were made: 15 children (32 %) had secondary lactase deficiency, 9 children (19 %) had sensitization to cow's milk protein and caseins. Molecular-genetic analysis of С > Т polymorphism at position 13910 of lactase gene (LСT) demonstrated that C/C-13910 genotype was observed in 44.7 % of children, С/Т-13910 heterozygous genotype was found in 36.2 %, and 19.1 % of children had Т/Т-13910 genotype; these were interpreted in conjunction with other clinical criteria for verification of secondary lactase deficiency diagnosis. CONCLUSIONS: Assessment of children over time during their treatment showed that combined therapy using lactase preparation and probiotics contributed to relief of clinical symptoms. All patients had their fecal pH increased (> 5.5), whereas the majority of children demonstrated improvement yet on days 2-3 (i.e., decrease in pain syndrome, flatulency, and stool frequency; restoration of normal stool consistency). Based on the obtained data, we proposed a practical algorithm for verification and monitoring of children with gastrointestinal disorders.

Digestive Enzyme Replacement Therapy: Pancreatic Enzymes and Lactase.

Maldigestion occurs when digestive enzymes are lacking to help break complex food components into absorbable nutrients within the gastrointestinal tract. Education is needed to help patients manage the intricacies of digestive enzyme replacement therapies and ensure their effectiveness in reducing symptoms of maldigestion.

[Lactose intolerance: past and present. Part II]. / A laktózintoleranciáról: Múlt és jelen - II. rész.

The author summarises the interrelations between lactose intolerance, calcium and vitamin D metabolism and osteoporosis. Lactose intolerance enhances the risk of forearm and hip fractures in some patients. Lactase gene genotype and fracture risk are related in some populations. Calcium and vitamin D supplementation increase bone mineral content and they are justified in children, during pregnancy and lactation, and in postmenopausal women. The intake of milk and milk products could increase the risk of ovarian carcinoma. CC genotype of the lactase gene increased the risk of colorectal carcinoma in Finns; no such effect was observed in British, Spanish and Italian patients. Even small quantities of lactose in drugs (10-750 mg) could elicit intolerance symptoms due to individual susceptibility. In spite of public knowledge and advertising, controlled studies did not prove the beneficial effect of either a lactose-free diet, enzyme supplementation or probiotics in an evidence-based manner. While accepted guidelines are lacking, a personalised therapy is mandatory. In spite of increasing public interest in lactose intolerance, many unknown factors must still be studied.

Lactase treated feeds to promote growth and feeding tolerance in preterm infants.

BACKGROUND: Successful transition from parenteral nutrition to full enteral feedings during the immediate neonatal period is associated with improved growth in preterm infants. Lactase is the last of the major intestinal disaccharidases to develop in preterm infants. Because of inadequate lactase activity, preterm infants are unable to digest lactose. Lactase preparations could potentially be used to hydrolyse lactose in formulas and breast milk to minimize lactose malabsorption in preterm infants. OBJECTIVES: To assess the effectiveness and safety of the addition of lactase to milk compared to placebo or no intervention for the promotion of growth and feeding tolerance in preterm infants. PRIMARY OUTCOMES: weight gain expressed as grams/kg/day, growth expressed as weight, length and head circumference percentile for postmenstrual age (PMA), assessed at birth and at 40 weeks PMA, days to achieve full enteral feeds. SECONDARY OUTCOMES: several common outcomes associated with preterm birth, and adverse effects. SEARCH METHODS: Electronic and manual searches were conducted in January 2005 of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2004, Issue 4), MEDLINE (1966 to Jan 2005), EMBASE (1980 to Jan 2005) and CINAHL (1982 to Jan 2005), personal files, bibliographies of identified trials and abstracts by the Pediatric Academic Societies' Meetings and the European Society of Pediatric Research Meetings published in Pediatric Research. The searches were repeated in May 2012 of The Cochrane Library, MEDLINE, EMBASE and CINAHL and abstracts from the Pediatric Academic Societies' Annual Meetings from 2000 to 2012 (Abstracts2View). The Web of Science was searched using the only previously identified trial by Erasmus 2002 as the starting point to search for additional trials that cited this trial. SELECTION CRITERIA: Types of studies: randomized or quasi-randomized controlled trials. PARTICIPANTS: preterm infants < 37 weeks PMA. INTERVENTION: addition of lactase to milk versus placebo or no intervention. DATA COLLECTION AND ANALYSIS: The standard methods of the Cochrane Neonatal Review Group were followed independently by the review authors to assess study quality and report outcomes. Treatment effects, calculated using Review Manager 5, included risk ratio (RR), risk difference (RD) and mean difference (MD), all with 95% confidence intervals (CI). A fixed-effect model was used for meta-analyses. We did not perform heterogeneity tests as only one study was identified. MAIN RESULTS: The repeat searches conducted in May 2012 did not identify any additional studies for inclusion. One study enrolling 130 infants of 26 to 34 weeks PMA (mean postnatal age at entry 11 days) was identified and no identified study was excluded. The study was a double blind randomized controlled trial of high quality. Lactase treated feeds were initiated when enteral feedings provided > 75% of daily intake. None of the primary outcomes outlined in the protocol for this review and only one of the secondary outcomes, necrotizing enterocolitis (NEC) were reported on. The RR for NEC was 0.32 (95% CI 0.01 to 7.79); the RD was -0.02 (95% CI -0.06 to 0.03) (a reduction which was not statistically significant). There was a statistically significant increase in weight gain at study day 10 in the lactase treated feeds group but not at any other time points. Overall, there was not a statistically significant effect on weight gain. No adverse effects were noted. AUTHORS' CONCLUSIONS: The only randomized trial to date provides no evidence of significant benefit to preterm infants from adding lactase to their feeds. Further research regarding effectiveness and safety are required before practice recommendations can be made. Randomized controlled trials comparing lactase versus placebo treated feeds and enrolling infants when enteral feeds are introduced are required. The primary and secondary outcomes for effectiveness and safety should include those identified in this review.

Management of infantile colic.

Although infantile colic is considered to be a self-limiting and benign condition, it is often a frustrating problem for parents and caregivers. It is a frequent source of consultation with healthcare professionals and is associated with high levels of parental stress and anxiety.(1,2) Several published reviews of the literature have explored dietary, pharmacological, complementary and behavioural therapies as options for the management of infantile colic.(1,3) Here, we assess whether these management options are supported by the literature and if there are any novel treatment options.

Lactose intolerance: from diagnosis to correct management.

This review discusses one of the most relevant problems in gastrointestinal clinical practice: lactose intolerance. The role of lactase-persistence alleles the diagnosis of lactose malabsorption the development of lactose intolerance symptoms and its management. Most people are born with the ability to digest lactose, the major carbohydrate in milk and the main source of nutrition until weaning. Approximately, 75% of the world's population loses this ability at some point, while others can digest lactose into adulthood. Symptoms of lactose intolerance include abdominal pain, bloating, flatulence and diarrhea with a considerable intraindividual and interindividual variability in the severity. Diagnosis is most commonly performed by the non invasive lactose hydrogen breath test. Management of lactose intolerance consists of two possible clinical choice not mutually exclusive: alimentary restriction and drug therapy.

Lactase treated feeds to promote growth and feeding tolerance in preterm infants.

BACKGROUND: Successful transition from parenteral nutrition to full enteral feedings during the immediate neonatal period is associated with improved growth in preterm infants. Lactase is the last of the major intestinal disaccharidases to develop in preterm infants. Because of inadequate lactase activity, preterm infants are unable to digest lactose. Lactase preparations could potentially be used to hydrolyze lactose in formulas and breast milk to minimize lactose malabsorption in preterm infants. OBJECTIVES: To assess the effectiveness and safety of the addition of lactase to milk compared to placebo or no intervention for the promotion of growth and feeding tolerance in preterm infants. PRIMARY OUTCOMES: Weight gain expressed as g/kg/day, growth expressed as weight, length and head circumference percentile for gestational age, assessed at birth and at 40 weeks post-menstrual age, days to achieve full enteral feeds. SECONDARY OUTCOMES: Several common outcomes associated with preterm birth, and adverse effects. SEARCH STRATEGY: Electronic and manual searches were conducted in January 2005 of Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2004), MEDLINE (1966-Jan 2005), EMBASE (1980-Jan 2005) and CINAHL (1982-Jan 2005), personal files, bibliographies of identified trials and abstracts by the Pediatric Academic Societies' and the European Society of Pediatric Research Meetings published in Pediatric Research. SELECTION CRITERIA: Types of studies: Randomized or quasi-randomized controlled trials. PARTICIPANTS: Preterm infants < 37 weeks gestational age. INTERVENTION: Addition of lactase to milk versus placebo or no intervention. DATA COLLECTION AND ANALYSIS: The standard methods of the Cochrane Neonatal Review Group were followed independently by the reviewers to assess study quality and report outcomes. Treatment effects, calculated using RevMan 4.2, included relative risk (RR), risk difference (RD) and mean difference (MD), all with 95% confidence intervals (CI). A fixed effect model was used for meta-analyses. Heterogeneity tests were not performed as only one study was identified. MAIN RESULTS: One study enrolling 130 infants of 26 - 34 weeks postconceptual age (mean postnatal age at entry 11 days) was identified and no identified study was excluded. The study was a double blind randomized controlled trial of high quality. Lactase treated feeds were initiated when enteral feedings provided > 75% of daily intake. None of the primary outcomes outlined in the protocol for this review and only one of the secondary outcomes, necrotizing enterocolitis (NEC), were reported on. The RR for NEC was 0.32 (95% CI 0.32 (0.01, 7.79); the RD was -0.02 (95% CI -0.06, 0.03) (a reduction which was not statistically significant). There was a statistically significant increase in weight gain at study day 10 in the lactase treated feeds group but not at any other time points. Overall, there ws not a statistically significant effect on weight gain. No adverse effects were noted. AUTHORS' CONCLUSIONS: The only randomized trial to date provides no evidence of significant benefit to preterm infants from adding lactase to their feeds. Further research regarding effectiveness and safety are required before practice recommendations can be made. Randomized controlled trials comparing lactase vs placebo treated feeds and enrolling infants when enteral feeds are introduced are recommended. The primary and secondary outcomes for effectiveness and safety should include those identified in this review.

[Benefits of a thickened infant formula with lactase activity in the management of benign digestive disorders in newborns]. / Intérêt d'une formule infantile épaissie avec activité lactasique dans la prise en charge des troubles digestifs bénins du nourrisson.

This study aimed at evaluating the interest of a thickened infant formula with lactase activity by comparison with a standard infant formula in the management of benign digestive disorders in infants. Infants of both sex (N =109), ranging in age from 0 to 3 months, were included in a randomised double blind trial. Infants went to the paediatrician because of benign digestive disorders such as regurgitation, eructation or hiccup, colic, persistent crying and/or meteorism. Nine hundred and three infants were included and randomised in two parallel groups: they consumed daily either the thickened infant formula with lactase activity or a standard infant formula. There were no significant difference in the infants included in both groups. Both formula were well accepted and tolerated. Growth of the infants and compliance during the study were identical and good in the two groups. The efficiency of the formula tested was showed on digestive symptoms through: a decrease of the intensity of the digestive discomforts more important in the test than in the standard formula group; a decrease of the intensity of the gaz significantly more important in the test than in the standard formula group; significant decreases in frequency and intensity of the gaz in the test group while there were no significant diminution in the standard group; This study showed the good tolerance, acceptability and efficiency of a thickened infant formula with lactase activity on benign digestive disorders of young infants.