Clinical Response to Two Formulas in Infants with Parent-Reported Signs of Formula Intolerance: A Multi-Country, Double-Blind, Randomized Trial.

BACKGROUND: Signs of feeding intolerance are common in formula-fed infants. We evaluated the clinical response to a partially hydrolyzed 100% whey protein formula with high sn-2 palmitate and reduced lactose (FA) and to an alpha-lactalbumin-enriched whey-predominant intact protein formula with full lactose (FB) in healthy full-term infants with parent-reported signs of feeding intolerance. METHODS: In a double-blind, parallel-group trial in 6 Asian study centers, exclusively formula-fed infants aged 30 to 90 days, whose parents reported fussiness-crying for ≥2 hours/day plus gassiness and/or stooling difficulty, and intended to switch formula, were randomly assigned to FA (n = 130) or FB (n = 129) for 14 days. Primary endpoint was daily duration of fussiness-crying. Secondary endpoints included gassiness, spitting-up, vomiting, sleep pattern, Infant Gastrointestinal Symptom Questionnaire (IGSQ) Index, infant temperament and maternal anxiety. RESULTS: Mean ± SE minutes/day of fussiness-crying in the 256 analyzed infants (FA, n = 127 and FB, n = 129) substantially decreased from baseline to study end in FA (291 ± 14 to 140 ± 8; -52%, P < .001), and FB (313 ± 14 to 153 ± 11, -51%, P < .001) with no difference between groups. Similarly, gassiness, spitting-up, vomiting and sleep pattern significantly improved by study end for both formulas. Mean ± SE IGSQ index scores significantly decreased from baseline to study end (FA: 44.5 ± 0.9 to 28.6 ± 0.7; FB: 44.5 ± 0.8 to 29.0 ± 0.7; P < .001) with no differences between groups. Infant temperament and maternal anxiety also improved significantly in both groups by study end. CONCLUSION: Switching from standard, full-lactose, intact whey/casein infant formulas to either study formula resulted in an improvement of gastrointestinal symptoms and associated behaviors in infants with signs of feeding intolerance. TRIAL REGISTRATION: https://clinicaltrials.gov, NCT02021058.

Unremitting watery diarrhoea in early childhood period.

Chronic watery diarrhoea can be a presentation of gastrointestinal disease itself or a less-evident systemic disease. A 17-month-old boy presented with intractable diarrhoea, failure to gain weight, refractory tachycardia and severe hypertension. The ability to recognise and make a quick diagnosis of secretory type of diarrhoea dictated the outcome of patients with this ailment. Catecholamine hypersecretion was considered with the additional clues of refractory tachycardia and hypertension, a well-recognised phenomenon of neuroblastic tumours. A neuroblastic tumour can lead to vasoactive intestinal peptide (VIP) overexpression, which may result in secretory diarrhoea. In this situation, measurements of plasma VIP enabled crucial diagnosis. Imaging studies were used to identify and localise a neuroblastic tumour. Subsequent removal of the tumour was curative and led to the resolution of the symptoms.

Effect of a whey-predominant starter formula containing LCPUFAs and oligosaccharides (FOS/GOS) on gastrointestinal comfort in infants.

Development of new infant formulas aims to replicate the benefits of breast milk. One benefit of breast milk over infant formulas is greater gastrointestinal comfort. We compared indicators of gastrointestinal comfort in infants fed a whey-predominant formula containing long-chain polyunsaturated fatty acids, galacto-oligo-saccharides and fructo-oligosaccharides, and infants fed a control casein-predominant formula without additional ingredients. The single-centre, prospective, double-blind, controlled trial randomly assigned healthy, full-term infants (n=144) to receive exclusively either experimental or control formula from 30 days to 4 months of age. A group of exclusively breast-fed infants served as reference (n=80). At 1, 2, 3, and 4 months, infants' growth parameters were measured and their health assessed. Parents recorded frequency and physical characteristics of infants' stool, frequency of regurgitation, vomiting, crying and colic. At 2-months, gastric emptying (ultrasound) and intestinal transit time (H2 breath test) were measured, and stool samples collected for bacterial analysis. Compared to the control (n=69), fewer of the experimental group (n=67) had hard stools (0.7 vs 7.5%, p<0.001) and more had soft stools (90.8 vs 82.3%, p<0.05). Also compared to the control, the experimental group's stool microbiota composition (mean % bifidobacteria: 78.1 (experimental, n=17), 63.7 (control, n=16), 74.3 (breast-fed, n=20), gastric transit times (59.6 (experimental, n=53), 61.4 (control, n=62), 55.9 (breast-fed, n=67) minutes) and intestinal transit times (data not shown) were closer to that of the breast-fed group. Growth parameter values were similar for all groups. The data suggest that, in infants, the prebiotic-containing whey-based formula provides superior gastrointestinal comfort than a control formula.

Incidence and risk factors of upper gastrointestinal bleeding in mechanically ventilated children.

OBJECTIVE: To identify the incidence and factors related to upper gastrointestinal (UGI) bleeding in children requiring mechanical ventilation for longer than 48 hrs. DESIGN: Prospective analytic study. SETTING: Ten-bed-pediatric intensive care unit of a tertiary care University Hospital. PATIENTS: A total of 110 patients requiring mechanical ventilation for longer than 48 hrs from January 1, 2005 to December 31, 2005. MEASUREMENTS AND RESULTS: UGI bleeding was defined by evidence of blood in nasogastric aspirates, hematemesis, or melena within 5 days of pediatric intensive care unit admission. We prospectively collected data on patient demographics, admission diagnosis, operative status, and pediatric risk of mortality score. UGI bleeding and the potential risk factors including organ failure, coagulopathy, maximum ventilator setting, enteral feeding, stress ulcer prophylaxis as well as sedation were daily monitored. Of the 110 patients who required mechanical ventilation for >48 hrs, the incidence of UGI bleeding was 51.8%, in which 3.6% of the cases presented with clinically significant bleeding (shock, requiring blood transfusion and/or surgery). Significant risk factors were thrombocytopenia, prolonged partial thromboplastin time, organ failure, high pressure ventilator setting >/=25 cm H2O, and pediatric risk of mortality score >/= 10 using univariate analysis. However, the independent factors of UGI bleeding in the multivariate analysis were organ failure (relative risk = 2.85, 95% confidence interval 1.18-6.92) and high pressure ventilator setting >/=25 cm H2O (relative risk = 3.73, 95% confidence interval 1.59-8.72). CONCLUSION: The incidence of UGI bleeding is high in children requiring mechanical ventilation. Organ failure and high pressure ventilator setting are significant risk factors for UGI bleeding.

Randomized control trial of live Lactobacillus acidophilus plus Bifidobacterium infantis in treatment of infantile acute watery diarrhea.

OBJECTIVE: To evaluate the effectiveness of live Lactobacillus acidophilus plus Bifidobacterium infantis in the treatment of acute watery diarrhea. DESIGN: Open, randomized control trial. SETTING: King Chulalongkorn Memorial Hospital, Bangkok, Thailand. MATERIAL AND METHOD: Seventy-one infants (aged 1-24 months) with acute watery diarrhea that presented at Department of Pediatrics, King Chulalongkorn Memorial Hospital, Bangkok were enrolled after parental signed informed consent. They were randomized into 2 groups. The Study group (n = 35) received live Lactobacillus plus Bifidobacterium (3 x 10(9) CFU) bid and ORS and the Control group (n = 36) received ORS only. All infants received lactose free milk. Case record forms were completed daily for 5 days by the parents. RESULTS: All 71 infants completed the present study. There was no difference of the patients'characteristics and baseline clinical symptoms between the study group and the control group. Live Lactobacillus plus Bifidobacterium shortened the diarrhea duration (1.6 +/- 0.7 days vs 2.9 +/- 1.7 days, p < 0.01) compared to controls. However the stool frequency and duration of hospitalization were not significantly different (p > 0.05, study group vs control group). CONCLUSION: Live Lactobacillus acidophilus plus Bifidobacterium infantis may be an effective treatment for acute watery diarrhea in infants. The 2-day course treatment can significantly shorten the duration of diarrhea.

Prevalence of CagA and VacA genotype of Helicobacter pylori in Thai children.

UNLABELLED: Seroprevalence of Helicobacter pylori infection in children is variable according to geographical location and family sanitation. A previous study in Bangkok showed an incidence of 25.5% in 1998. The higher incidence in the urban and rural area is predicted in lower economic classes and poor sanitation. OBJECTIVE: To study the occurance of CagA and VacA genotype in Thai children using the Western blot technique. MATERIAL AND METHOD: Sera of 159 Thai native children aged 0-15 year without associated abdominal pain from different provinces in 4 parts of the Kingdom of Thailand were tested with the rapid screening test for H. pylori. The positive specimen was further tested with the Western blot technique for determination of Urea A (p37), CagA (p116) and VacA (p89). RESULT: Fiftyfive andfifty two (34.6%) were tested positive by the rapid test while 32.7% were positivefor the band of current infection marker (CIM). The 28 selected positive sera with complete history of housing and water supply were analysed. Thai children living in urban areas have a higher prevalence and the CagA+, VacA+ are found in 96.43% of infected patients. The transmission may be through the water supply. CONCLUSION: A high prevalence of Helicobacter pylori infection was found in childhood period in urban areas and may be associated with the local water supply.

Effect of carob bean on gastric emptying time in Thai infants.

Thickening agents, such as carob bean gum or galactomannan, have been successfully administered for the treatment of gastroesophageal reflux in infants. To study the effect of carob bean gum on gastric emptying and to symptoms of regurgitation, we recruited 20 full term Thai infants (mean age=13.4+/-7 week; mean body weight=4943+/-1272gm) without pathological gastroesophageal reflux. Initially, we determined half time gastric emptying (T 1/2 GET) by Tc99m radioscintigraphy method (mean T 1/2 GET=116.1+/-72 min) in infants consuming standard infant cow's milk formula for 2 weeks. Afterwards, carob bean infant formula was given for 2-4 weeks and weight gain, vomiting symptoms, night cough, colic, flatus, defaecation character and T 1/2 GET were assessed. There were statistically significant improvements in symptoms of vomiting (a smaller quantity P<0.001 and frequency of vomiting P<0.0001) and improvements in weight gain per week (W1=121.2+106.9gm, W2=221.3+136.1gm; P=0.005) when infants consumed the carob bean formula. However, there was no significance difference in gastric emptying half time (GET1=116.1+72, GET2=148.5+130.9; P=0.154). In conclusion, carob bean gum, as a thickening agent, improves the clinical symptoms of regurgitating infants, but does not significantly alter the gastric emptying physiology.

Gastrointestinal manifestations of cow's milk protein allergy during the first year of life.

BACKGROUND: Cow's milk protein sensitive enteropathy (CMPSE) is a common condition in the first year of life. Clinically CMPSE usually presents with symptoms like vomiting, chronic diarrhea, mucous bloody diarrhea and hematemesis. More unusual symptoms associated with CMPSE are infantile colic, gastroesophageal reflux and chronic constipation. The objective of this study was to assess the gastrointestinal manifestations and allergic march in CMPSE patients. METHOD: The authors reviewed the records of 10 CMPSE patients observed by the Gastrointestinal Unit at King Chulalongkorn Memorial Hospital from 1997-2001 including patient characteristics, laboratory investigations, endoscopy and follow-up outcome. RESULTS: Of 10 CMPSE patients, the median age of CMPSE onset was 3.5 months. The gastrointestinal manifestations were hematemesis (n = 6), mucous bloody diarrhea (n = 3) and chronic watery diarrhea (n = 2). Exclusively breast-fed infants seemed to have more delayed onset of symptoms than those who were not. Anemia (n = 3), high serum IgE (n = 4) and positive skin prick test for cow's milk (n = 5) were found. Neither peripheral eosinophilia nor hypoalbuminemia was found. Endoscopy revealed acute and chronic gastritis. Treatment was successful by changing to soy or extensive hydrolysate formula with mean duration of cow's milk intolerance of 24 months. In 2-year follow-up, three of ten patients who had high serum IgE level developed allergic rhinitis and eczema. CONCLUSION: CMPSE can be manifested in various symptoms. Exclusive breast feeding for more than 4 months can postpone the onset of CMPSE. Serum IgE or specific IgE level to cow's milk protein may identify the atopic career of CMPSE individuals.