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The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial.
Huang, Y, Zhou, Y, Li, H, Chen, Y, Mu, Y, Yuan, A, Yang, Y, Liu, J
Nutrients. 2021;(10)
Abstract
Partially hydrolyzed formula (pHF) containing low lactose and probiotics may benefit the gastrointestinal health of infants. We aimed to assess the effects of pHF on mild gastrointestinal disorders (MGDs) of infants. In this single-armed trial, 80 full-term infants with MGDs were enrolled and fed a pHF for 14 consecutive days. The primary outcome resulted from the scores of gastrointestinal symptoms reported by parents using a validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) at Day 0 (baseline), Day 7, and Day 14. The total IGSQ scores ranged from 13 to 65. Higher scores indicated worse gastrointestinal symptoms. The IGSQ scores (mean ± SD) decreased from Day 0 (36.0 ± 5.7) to Day 7 (28.7 ± 7.4) and Day 14 (26.5 ± 8.1 (p < 0.001), with corresponding digestive distress prevalence (IGSQ score > 30) decreasing from 87.5% to 35.0% and 28.8% (p < 0.001). In the first three days, vomiting and flatulence scores decreased at Day 1 versus Day 0, and the crying score decreased at Day 2, but no significant changes were observed for fussy and stool characteristics. All growth parameters increased and no parents reported adverse events. In conclusion, feeding with a pHF containing low lactose and probiotics may comfort infants with MGDs, and the comforting effect likely manifests early in the first three days of the feeding interventions. Trial registration: ClinicalTrials.gov NCT04112056.
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A Pilot and Feasibility Study of Oatmeal Consumption in Children to Assess Markers of Bowel Function.
Paruzynski, H, Korczak, R, Wang, Q, Slavin, J
Journal of medicinal food. 2020;(5):554-559
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Inadequate dietary fiber intake contributes to irregular bowel movements and may contribute to difficulty with defecation in children. Whole grain foods, such as oatmeal, may improve stool consistency and stool frequency in children; however, no studies have examined its effects. The purpose of this study was to investigate if 2 weeks of oatmeal consumption in children (ages 7-12 years) increases stool frequency, improves stool consistency, and gastrointestinal (GI) symptoms. In this single-arm intervention study, children who reported ≤5 bowel movements per week during screening, consumed two servings of instant oatmeal daily for 2 weeks. The primary outcome was stool frequency and secondary outcomes included stool consistency and GI symptoms. Participants recorded bowel movements daily, food intake, and GI symptoms during baseline and 2 intervention weeks. Photos of the children's stool were taken at three timepoints during the study to assess stool consistency. In total, 33 children (15 female and 18 male) completed the study. Linear mixed models were used to detect change between baseline and the intervention weeks and accounted for repeated measures within subjects. No statistical differences in stool frequency or consistency were observed between the intervention weeks vs. baseline; however, dietary fiber intake significantly increased during the 2 weeks of oatmeal consumption (P = .008). The addition of oatmeal to children's diets is an effective way to increase fiber consumption and may reduce some GI symptoms such as gas, straining, and feeling of incomplete evacuation. Trial identification number: NCT02868515.
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Nutritional Status, Body Surface, and Low Lean Body Mass/Body Mass Index Are Related to Dose Reduction and Severe Gastrointestinal Toxicity Induced by Afatinib in Patients With Non-Small Cell Lung Cancer.
Arrieta, O, De la Torre-Vallejo, M, López-Macías, D, Orta, D, Turcott, J, Macedo-Pérez, EO, Sánchez-Lara, K, Ramírez-Tirado, LA, Baracos, VE
The oncologist. 2015;(8):967-74
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BACKGROUND The main reason for dose reduction of afatinib is gastrointestinal toxicity (GT). In a phase II study, we analyzed anthropometrical, nutritional, and biochemical factors associated with GT induced by afatinib. MATERIALS AND METHODS Patients diagnosed with non-small cell lung cancer who progressed to prior chemotherapy received 40 mg of afatinib. Malnutrition was determined by Subjective Global Assessment, and lean body mass (LBM) was determined by computed tomography scan analysis using a pre-established Hounsfield unit threshold. Toxicity was obtained during four cycles by Common Terminology Criteria for Adverse Events. RESULTS Eighty-four patients were enrolled. Afatinib was administered as the second, third, and fourth line of treatment in 54.8%, 38.1%, and 7.12% of patients, respectively. Severe diarrhea, mucositis, and overall severe GT were present in 38.9%, 28.8%, and 57.5%, respectively. Of the patients, 50% developed dose-limiting toxicity (DLT). Patients with malnutrition have higher risk for severe GT. Patients with lower LBM and body mass index developed more DLT (71.4% vs. 18.8%). CONCLUSION Malnutrition is associated with a higher risk of severe GT induced by afatinib. Determination of nutritional status and body composition are helpful in identifying patients at higher risk of severe GT and could allow initiating treatment with lower doses according to tolerance.
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Lactose intolerance is not the cause of gastrointestinal adverse effects in beta thalassemia patients treated with deferasirox.
Pazgal, I, Brown, M, Perets, TT, Niv, Y, Rachmilewitz, E, Stark, P
American journal of hematology. 2014;(9):938-9
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Safety and adequacy of a semi-elemental formula for children with gastro-intestinal disease.
Vandenplas, Y, Plaskie, K, Hauser, B
Amino acids. 2010;(3):909-14
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A prospective, open trial was conducted to evaluate the nutritional adequacy of a semi-elemental diet in 47 children with functional gastro-intestinal disorders. Nutritional adequacy was assessed based on growth relative to Euro-growth standards for body mass index (BMI)-for-age z-scores and evaluations of blood parameters. Twenty-five patients completed the study. In total, 533 l of "New-Alfare" was consumed during 775 trial-days. The mean intake per infant was 85.8 +/- 26.8 kcal/kg/day or 122.5 +/- 38.3 ml/kg/day. Weight and length evolution during the 4 weeks trial were within normal range. The mean BMI-for-age z-score (P < 0.05) and albumin concentration (P < 0.01) increased significantly after 4 weeks. Plasma threonine concentration decreased significantly (P = 0.01) and the tryptophan concentration increased (P = 0.06). No adverse events related to the study formula were reported. These results show that "New Alfaré" is safe and nutritionally adequate for pediatric patients with gastro-intestinal disease.
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Community-based randomized double-blind study of gastrointestinal effects and copper exposure in drinking water.
Araya, M, Olivares, M, Pizarro, F, Llanos, A, Figueroa, G, Uauy, R
Environmental health perspectives. 2004;(10):1068-73
Abstract
We assessed gastrointestinal effects in 1,365 adults exposed to either < 0.01 (controls), 2, 4, or 6 mg copper/L of drinking water for 2 months in a randomized, double-blind community-based study. The risk of symptoms increased with increasing Cu exposure and decreased with time. The best model by counting-process analysis included Cu concentration and sex. The risk of symptoms remained significantly higher in women than in men during weeks 1-4 for all concentrations tested; at week 1 comparison with the < 0.01-mg/L group showed that differences became significant in women at 4 mg/L [relative risk (RR) = 1.53; 95% confidence interval (CI), 1.02-2.05), and in men at 6 mg/L (RR = 1.9; 95% CI, 1.02-2.79). At week 2 for men and week 4 in women, the Cu concentration required to obtain significant differences on symptom report was > 6 mg Cu/L. We conclude that exposure to Cu in drinking water results in gastrointestinal symptoms, which are modulated by Cu concentration, time, and sex.
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The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903].
Mills, E, Prousky, J, Raskin, G, Gagnier, J, Rachlis, B, Montori, VM, Juurlink, D
BMC clinical pharmacology. 2003;:4
Abstract
BACKGROUND Niacin is widely available over the counter (OTC). We sought to determine the safety of 500 mg immediate release niacin, when healthy individuals use them as directed. METHODS 51 female and 17 male healthy volunteers (mean age 27 years SD 4.4) participated in a randomized placebo-controlled blinded trial of a single dose of an OTC, immediate-release niacin 500 mg (n = 33), or a single dose of placebo (n = 35) on an empty stomach. The outcomes measured were self-reported incidence of flushing and other adverse effects. RESULTS 33 volunteers on niacin (100%) and 1 volunteer on placebo (3%) flushed (relative risk 35, 95% confidence interval (CI) 6.8-194.7). Mean time to flushing on niacin was 18.2 min (95% CI: 12.7-23.6); mean duration of flushing was 75.4 min (95% CI: 62.5-88.2). Other adverse effects occurred commonly in the niacin group: chills (51.5% vs. 0%, P <.0001), generalized pruritus (75% vs. 0%, P = <.001), gastrointestinal upset (30% vs. 3%, P =.005), and cutaneous tingling (30% vs. 0%, P = <.001). Six participants did not tolerate the adverse effects of niacin and 3 required medical attention. CONCLUSION Clinicians counseling patients about niacin should alert patients not only about flushing but also about gastrointestinal symptoms, the most severe in this study. They should not trust that patients would receive information about these side effects or their prevention (with aspirin) from the OTC packet insert.
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Gastrointestinal tolerance of a new infant milk formula in healthy infants: multicenter study conducted in Taiwan.
Chen, N, Alarcon, PA, Comer, GM, Tressler, RL
Asia Pacific journal of clinical nutrition. 2002;(2):151-6
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The objective of this study was to test whether the gastrointestinal tolerance of a new infant formula equalled or exceeded the tolerance of other milk-based infant formulas, and to compare the tolerance of the new formula to that of human milk. This prospective, observational, multicenter, open-label study was conducted in Taiwan. Healthy, full-term infants aged 28-98 days were enrolled on their current feeding regimen (no treatment assigned). Feeding regimens included human milk (HM), a new infant formula (NF, Similac Advance), other marketed infant formulas (OF, mainly Enfalac or S-26, HM + NF and HM + OF. Data for stool frequency, stool consistency and gastrointestinal intolerance symptoms were recorded in study diaries by parents for a period of two weeks. Gastrointestinal tolerance was evaluated in 967 infants, of whom 481 (49.7%) received NF, 312 (32.2%) received OF, 101 (10.4%) received HM + NF, 41 (4.2%) received HM + OF and 32 (3.3%) received HM. Infants fed HM only had softer and more frequent stools than those who received NF only or OF only (P < 0.001). Infants fed NF only had softer stools than those fed OF only (P < 0.001), including those fed either Enfalac or S-26 (P < 0.001). There were no significant differences between feeding groups for the incidence of general intolerance, spit-up or flatulence. All feeding regimens were well tolerated. We thereby concluded that NF is well tolerated in healthy infants and results in stool consistencies that more closely resemble those of infants fed human milk than those of infants fed other formulas.
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Randomised controlled study of oral erythromycin for treatment of gastrointestinal dysmotility in preterm infants.
Ng, PC, So, KW, Fung, KS, Lee, CH, Fok, TF, Wong, E, Wong, W, Cheung, KL, Cheng, AF
Archives of disease in childhood. Fetal and neonatal edition. 2001;(3):F177-82
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AIM: To evaluate the effectiveness of oral erythromycin as a prokinetic agent for the treatment of moderately severe gastrointestinal dysmotility in preterm very low birthweight infants. METHODS A prospective, double blind, randomised, placebo controlled study in a tertiary referral centre of a university teaching hospital was conducted on 56 preterm infants (< 1500 g) consecutively admitted to the neonatal unit. The infants were randomly allocated by minimisation to receive oral erythromycin (12.5 mg/kg, every six hours for 14 days) or an equivalent volume of placebo solution (normal saline) if they received less than half the total daily fluid intake or less than 75 ml/kg/day of milk feeds by the enteral route on day 14 of life. The times taken to establish half, three quarters, and full enteral feeding after the drug treatment were compared between the two groups. Potential adverse effects of oral erythromycin and complications associated with parenteral nutrition were assessed as secondary outcomes. RESULTS Twenty seven and 29 infants received oral erythromycin and placebo solution respectively. The times taken to establish half, three quarters, and full enteral feeding after the drug treatment were significantly shorter in the group receiving oral erythromycin than in those receiving the placebo (p < 0.05, p < 0.05 and p < 0.0001 respectively). There was also a trend suggesting that more infants with prolonged feed intolerance developed cholestatic jaundice in the placebo than in the oral erythromycin group (10 v 5 infants). None of the infants receiving oral erythromycin developed cardiac dysrhythmia, pyloric stenosis, or septicaemia caused by multiresistant organisms. CONCLUSIONS Oral erythromycin is effective in facilitating enteral feeding in preterm very low birthweight infants with moderately severe gastrointestinal dysmotility. Treated infants can achieve full enteral feeding 10 days earlier, and this may result in a substantial saving on hyperalimentation. However, until the safety of erythromycin has been confirmed in preterm infants, this treatment modality should remain experimental. Prophylactic or routine use of this medication for treatment of mild cases of gastrointestinal dysmotility is probably not warranted at this stage.
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Effect of long term consumption of probiotic milk on infections in children attending day care centres: double blind, randomised trial.
Hatakka, K, Savilahti, E, Pönkä, A, Meurman, JH, Poussa, T, Näse, L, Saxelin, M, Korpela, R
BMJ (Clinical research ed.). 2001;(7298):1327
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OBJECTIVE To examine whether long term consumption of a probiotic milk could reduce gastrointestinal and respiratory infections in children in day care centres. DESIGN Randomised, double blind, placebo controlled study over seven months. SETTING 18 day care centres in Helsinki, Finland. PARTICIPANTS 571 healthy children aged 1-6 years: 282 (mean (SD) age 4.6 (1.5) years) in the intervention group and 289 (mean (SD) age 4.4 (1.5) years) in the control group. INTERVENTION Milk with or without Lactobacillus GG. Average daily consumption of milk in both groups was 260 ml. MAIN OUTCOME MEASURES Number of days with respiratory and gastrointestinal symptoms, absences from day care because of illness, respiratory tract infections diagnosed by a doctor, and course of antibiotics. RESULTS Children in the Lactobacillus group had fewer days of absence from day care because of illness (4.9 (95% confidence interval 4.4 to 5.5) v 5.8 (5.3 to 6.4) days, 16% difference, P=0.03; age adjusted 5.1 (4.6 to 5.6) v 5.7 (5.2 to 6.3) days, 11% difference, P=0.09). There was also a relative reduction of 17% in the number of children suffering from respiratory infections with complications and lower respiratory tract infections (unadjusted absolute % reduction -8.6 (-17.2 to -0.1), P=0.05; age adjusted odds ratio 0.75 (0.52 to 1.09), P=0.13) and a 19% relative reduction in antibiotic treatments for respiratory infection (unadjusted absolute % reduction -9.6 (-18.2 to -1.0), P=0.03; adjusted odds ratio 0.72 (0.50 to 1.03), P=0.08) in the Lactobacillus group. CONCLUSIONS Lactobacillus GG may reduce respiratory infections and their severity among children in day care. The effects of the probiotic Lactobacillus GG were modest but consistently in the same direction.