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1.
Efficacy of Soy-Based Formulas in Alleviating Gastrointestinal Symptoms in Infants With Milk-Based Formula Intolerance: A Randomized Clinical Trial.
Lasekan, JB, Baggs, GE
Clinical pediatrics. 2021;(3):184-192
Abstract
A randomized, blinded pilot clinical study was conducted to assess gastrointestinal (GI) tolerance in healthy, full-term infants (2-9 weeks old), whose pediatricians recommended a formula change due to perceived cow's milk formula intolerance. Infants were randomized and exclusively fed either a commercial control soy formula (SF; n = 22), an experimental partially hydrolyzed SF (10% hydrolyzed, n = 23), or a 5% hydrolyzed SF (n = 26) for 2 weeks. Age-matched reference cohorts (n = 72) with no GI intolerance on milk-based formula were assessed in parallel. Results indicated that all SF-fed groups contributed to reduction (P < .05) in common GI tolerance symptoms to levels not different from the non-symptomatic reference cohort at study end. The control SF group had more reduced fussiness, gas, and crying and higher formed stools versus hydrolyzed SF groups. In conclusion, the study suggests that SFs reduced GI intolerance symptoms in otherwise healthy infants with poor tolerance on milk-based formulas.
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2.
Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study).
Reintam Blaser, A, Padar, M, Mändul, M, Elke, G, Engel, C, Fischer, K, Giabicani, M, Gold, T, Hess, B, Hiesmayr, M, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(8):4932-4940
Abstract
BACKGROUND & AIMS To develop a five grade score (0-4 points) for the assessment of gastrointestinal (GI) dysfunction in adult critically ill patients. METHODS This prospective multicenter observational study enrolled consecutive adult patients admitted to 11 intensive care units in nine countries. At all sites, daily clinical data with emphasis on GI clinical symptoms were collected and intra-abdominal pressure measured. In five out of 11 sites, the biomarkers citrulline and intestinal fatty acid-binding protein (I-FABP) were measured additionally. Cox models with time-dependent scores were used to analyze associations with 28- and 90-day mortality. The models were estimated with stratification for study center. RESULTS We included 540 patients (224 with biomarker measurements) with median age of 65 years (range 18-94), the Simplified Acute Physiology Score II score of 38 (interquartile range 26-53) points, and Sequential Organ Failure Assessment (SOFA) score of 6 (interquartile range 3-9) points at admission. Median ICU length of stay was 3 (interquartile range 1-6) days and 90-day mortality 18.9%. A new five grade Gastrointestinal Dysfunction Score (GIDS) was developed based on the rationale of the previously developed Acute GI Injury (AGI) grading. Citrulline and I-FABP did not prove their potential for scoring of GI dysfunction in critically ill. GIDS was independently associated with 28- and 90-day mortality when added to SOFA total score (HR 1.40; 95%CI 1.07-1.84 and HR 1.40; 95%CI 1.02-1.79, respectively) or to a model containing all SOFA subscores (HR 1.48; 95%CI 1.13-1.92 and HR 1.47; 95%CI 1.15-1.87, respectively), improving predictive power of SOFA score in all analyses. CONCLUSIONS The newly developed GIDS is additive to SOFA score in prediction of 28- and 90-day mortality. The clinical usefulness of this score should be validated prospectively. TRIAL REGISTRATION NCT02613000, retrospectively registered 24 November 2015.
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3.
Intra-Abdominal Pressure as a Marker of Enteral Nutrition Intolerance in Critically Ill Patients. The PIANE Study.
Bordejé, ML, Montejo, JC, Mateu, ML, Solera, M, Acosta, JA, Juan, M, García-Córdoba, F, García-Martínez, MA, Gastaldo, R, ,
Nutrients. 2019;(11)
Abstract
To determine whether elevated intra-abdominal pressure (IAP) is associated with a higher rate of enteral nutrition-related gastrointestinal (GI) complications; to assess the value of IAP as a predictor of enteral nutrition (EN) intolerance. Intensive Care Unit (ICU) patients on mechanical ventilation requiring at least 5 days of EN were recruited for a prospective, observational, non-interventional, multicenter study. EN was performed and GI complications were managed with an established protocol. IAP was determined via a urinary catheter. Patients who developed any GI complications were considered as presenting EN intolerance. Variables related to EN, IAP and GI complications were monitored daily. Statistical analysis compared patients without GI complications (group A) vs. GI complications (group B). 247 patients were recruited from 28 participating ICUs (group A: 119, group B: 128). No differences between groups were recorded. Patients in group B (p < 0.001) spent more days on EN (8.1 ± 8.4 vs. 18.1 ± 13.7), on mechanical ventilation (8.0 ± 7.7 vs. 19.3 ± 14.9) and in the ICU (12.3 ± 11.4 vs. 24.8 ± 17.5). IAP prior to the GI complication was (14.3 ± 3.1 vs. 15.8 ± 4.8) (p < 0.003). The best IAP value identified for EN intolerance was 14 mmHg but it had low sensitivity and specificity. Although a higher IAP was associated with EN intolerance, IAP alone did not emerge as a good predictor of EN intolerance in critically ill patients.
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4.
Safety and efficacy of intravenous ferric carboxymaltose in Japanese patients with iron-deficiency anemia caused by digestive diseases: an open-label, single-arm study.
Ikuta, K, Ito, H, Takahashi, K, Masaki, S, Terauchi, M, Suzuki, Y
International journal of hematology. 2019;(1):50-58
Abstract
Iron-deficiency anemia (IDA) accounts for majority of anemia. Although iron replacement therapy is effective, in Japan, conventional iron formulations have disadvantages such as gastrointestinal side effects for oral formulations and issues of frequent administration for intravenous (IV) formulations. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron source overseas. In this multi-center, open-label, single-arm study, we investigated the safety and efficacy of FCM up to 12 weeks after the start of administration in patients with IDA caused by digestive diseases. Thirty-nine patients diagnosed with IDA based on hemoglobin and serum ferritin levels were included. Eligible subjects were administered FCM until the total calculated iron dose (1000 or 1500 mg) was achieved over intervals of at least 1 week. A single iron dose was 500 mg. In the full analysis set (n = 39), the incidence of adverse events and adverse drug reactions was 71.8 and 48.7%, respectively. All events were as expected from the safety profile of IV iron. The mean change from baseline (10.39 g/dL) to the highest observed hemoglobin level was 3.31 g/dL. These results indicate the safety and efficacy of FCM for treating IDA caused by digestive diseases in Japanese patients.
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5.
Growth, Gastrointestinal Tolerance and Stool Characteristics of Healthy Term Infants Fed an Infant Formula Containing Hydrolyzed Whey Protein (63%) and Intact Casein (37%): A Randomized Clinical Trial.
Wu, SL, Ding, D, Fang, AP, Chen, PY, Chen, S, Jing, LP, Chen, YM, Zhu, HL
Nutrients. 2017;(11)
Abstract
To investigate whether healthy term infants, fed an infant formula containing hydrolyzed whey protein (HWP-F, hydrolyzed whey/intact casein =63/37), differ in growth, gastrointestinal tolerance and stool characteristics from those fed an infant formula containing intact whey protein (IWP-F, intact whey/intact casein =61/39) or breast milk. Healthy term infants, born within 14 days of the study's commencement, were randomly assigned to be fed IWP-F or HWP-F until 13 weeks of age, and breast-fed (BF) infants were enrolled as a reference group. Anthropometric measurements, gastrointestinal tolerance indexes and stool characteristics were assessed at baseline, and 7 and 13 weeks of age. There were no significant differences in any growth measurements and the occurrence of crying, spit-up and difficult defecation among the three feeding groups during the study period. However, daily feeding frequency was consistently lower in the formula-fed infants than in the BF group throughout the study (p < 0.05), and infants in the HWP-F group consumed more formula than those in the IWP-F group at 7 and 13 weeks of age (p ≤ 0.002). The HWP-F-fed infants had more similar stool characteristics to the breast-fed infants than infants in the IWP-F group at 13 weeks of age, regardless of frequency, volume, color or consistency of stool. This study demonstrates that the HWP-F could support the normal growth of healthy term infants, to a comparable extent to that of breast-fed infants during the first three months of life. Moreover, stool characteristics of HWP-F-fed infants are much closer to breast-fed infants than IWP-F-fed infants, but no significant gastrointestinal tolerance improvement was observed in HWP-F group.
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6.
Effect of saline 0.9% or Plasma-Lyte 148 therapy on feeding intolerance in patients receiving nasogastric enteral nutrition.
Reddy, S, Bailey, M, Beasley, R, Bellomo, R, Mackle, D, Psirides, A, Young, P
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine. 2016;(3):198-204
Abstract
OBJECTIVE To compare the effect of Plasma-Lyte (PL)-148 and saline 0.9% (saline) on gastrointestinal (GI) feeding intolerance in mechanically ventilated patients receiving nasogastric (NG) feeding in an intensive care unit. DESIGN AND SETTING A single-centre pilot study, nested within a multicentre, double-blind, cluster-randomised, double-crossover trial, performed in a mixed medical and surgical ICU. PARTICIPANTS All adult patients who required crystalloid fluid therapy as part of the 0.9% Saline versus Plasma-Lyte 148 for Intensive Care Unit Fluid Therapy (SPLIT) trial, were expected to need mechanical ventilation for more than 48 hours and were receiving enteral nutrition exclusively by NG tube were eligible. We enrolled 69 patients and assigned 35 to PL-148 and 34 to saline. INTERVENTIONS We randomly allocated saline or PL-148 for four alternating 7-week blocks, with staff blinded to the solution. MAIN OUTCOME MEASURES The primary outcome was the proportion of patients with GI feeding intolerance, defined as high gastric residual volume (GRV), diarrhoea or vomiting while receiving NG feeding in the ICU. The proportions of patients with each of high GRV, diarrhoea and vomiting were secondary outcomes. RESULTS In the PL-148 group, 21 of 35 patients (60.0%) developed GI feeding intolerance, compared with 22 of 34 patients (64.7%) in the saline group (odds ratio [OR], 0.82; 95% CI, 0.31-2.17; P = 0.69). A high GRV was seen in four of 35 patients (11.4%) in the PL-148 group, and in 11 of 34 patients (32.4%) in the saline group (OR, 0.27; 95% CI, 0.08-0.96; P = 0.04). CONCLUSION Among mechanically ventilated patients receiving NG feeding, the use of PL-148, compared with saline, did not reduce the proportion of patients developing GI feeding intolerance, but was associated with a decreased incidence of high GRV.
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7.
Gastrointestinal symptoms, inflammation and hypoalbuminemia in chronic kidney disease patients: a cross-sectional study.
Zhang, X, Bansal, N, Go, AS, Hsu, CY
BMC nephrology. 2015;:211
Abstract
BACKGROUND Few studies have focused on investigating hypoalbuminemia in patients during earlier stages of chronic kidney disease (CKD). In particular, little is known about the role of gastrointestinal (GI) symptoms. Our goal in this paper is to study how GI symptoms relate to serum albumin levels in CKD, especially in the context of and compared with inflammation. METHODS We performed a cross-sectional study of 3599 patients with chronic kidney disease enrolled in the Chronic Renal Insufficiency Cohort (CRIC) study. All subjects were asked to complete the Modification of Diet in Renal Disease (MDRD) study patient symptom form. Our main predictor is GI symptom score. Serum level of C-reactive protein (CRP) was measured as well. Main outcome measures are serum albumin levels and prevalence of hypoalbuminemia. RESULTS Of the participants assessed, mean serum albumin was 3.95 ± 0.46 g/dL; 12.7 % had hypoalbuminemia. Patients with lower estimated glomerular filtration rate (eGFR) were likely to have more GI symptoms (apparent at an eGFR <45 ml/min/1.73 m(2)). Patients with worse GI symptoms had lower dietary protein intake. GI symptoms, like inflammation, were risk factors for lower serum albumin levels. However, adding GI symptom score or CRP into the multivariable regression analysis, did not attenuate the association between lower eGFR and lower albumin or hypoalbuminemia. CONCLUSIONS Increased prevalence of GI symptoms become apparent among CKD patients at relatively high eGFR levels (45 ml/min/1.73 m(2)), long before ESRD. Patients with more severe GI symptoms scores are more likely to have hypoalbuminemia. But our data do not support GI symptoms/decreased protein intake or inflammation as being the main determinants of serum albumin level in CKD patients.
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8.
Enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients experiencing gastrointestinal intolerance: a multicenter, double-blind, randomized study.
Langone, AJ, Chan, L, Bolin, P, Cooper, M
Transplantation. 2011;(4):470-8
Abstract
BACKGROUND Two open-label studies demonstrated that conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) significantly reduces gastrointestinal (GI) symptom burden and improves GI-specific health-related quality of life. Using a randomized design, this study evaluated changes in GI symptoms and health-related quality of life in patients converted from MMF to EC-MPS versus patients who continued with MMF-based treatment. METHODS In this 4-week, multicenter, randomized, prospective, double-blind, parallel-group trial, renal transplant recipients with GI symptoms receiving MMF plus a calcineurin inhibitor ± corticosteroids were randomized to an equimolar dose of EC-MPS+MMF placebo or continue on their MMF-based regimen+EC-MPS placebo. The primary efficacy outcome was a change from baseline in total Gastrointestinal Symptom Rating Scale score of a minimally important difference of more than or equal to 0.3. RESULTS Three hundred ninety-six patients (EC-MPS group: n=199; MMF group: n=197) were included. A greater proportion of EC-MPS patients (62%) reached the primary efficacy outcome compared with MMF patients (55%); however, the difference was not statistically significant (P=0.15). EC-MPS patients had a significantly greater decrease in the Gastrointestinal Symptom Rating Scale indigestion syndrome dimension versus MMF patients. Within the subgroups of patients with diabetes, patients transplanted 6 to 12 months of study enrollment, and patients on steroids, a statistically significant greater proportion of EC-MPS versus MMF patients reached the primary efficacy outcome. CONCLUSIONS Conversion from MMF to EC-MPS may be associated with improvements in presence and severity of GI symptoms, particularly in patients with indigestion, diabetes, on steroids, and in patients converted between 6 and 12 months posttransplantation.
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9.
Improved gastrointestinal symptoms and quality of life after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients receiving tacrolimus.
Hwang, HS, Hyoung, BJ, Kim, S, Oh, HY, Kim, YS, Kim, JK, Kim, YH, Kim, YL, Kim, CD, Shin, GT, et al
Journal of Korean medical science. 2010;(12):1759-65
Abstract
It is reported that a conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) relieves gastrointestinal (GI) symptom burden and improves health-related quality of life (HRQoL). However, it is unclear whether renal transplant recipients using tacrolimus receive the same benefit from the conversion. In this prospective, multi-center, open-label trial, patients were categorized into two groups by their GI symptom screening. Equimolar EC-MPS (n=175) was prescribed for patients with GI burdens; those with no complaints remained on MMF (n=83). Gastrointestinal Symptom Rating Scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI) were evaluated at baseline and after one month. Patients and physicians completed Overall Treatment Effect (OTE) at one month. EC-MPS-converted patients had worse GSRS and GIQLI scores at baseline than MMF-continued patients (all P<0.001). Significant improvements in GSRS and GIQLI scores were observed for EC-MPS-converted patients at one month, but MMF-continued patients showed worsened GSRS scores (all P<0.05). OTE scale indicated that EC-MPS patients improved in overall GI symptoms and HRQoL more than MMF patients did (P<0.001). In tacrolimus-treated renal transplant recipients with GI burdens, a conversion from MMF to EC-MPS improves GI-related symptoms and HRQoL.
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10.
Efficacy of a synbiotic supplementation in the prevention of common winter diseases in children: a randomized, double-blind, placebo-controlled pilot study.
Cazzola, M, Pham-Thi, N, Kerihuel, JC, Durand, H, Bohbot, S
Therapeutic advances in respiratory disease. 2010;(5):271-8
Abstract
BACKGROUND AND AIMS The purpose of this study was to investigate the efficacy of a synbiotic supplementation in reducing common winter diseases in children. METHODS A randomized, double-blind, placebo-controlled, multicentre study was conducted in young school-age children (3-7 years old) during a winter period. Participants were otherwise healthy children who suffered from at least three episodes of ear, nose and throat (ENT), respiratory tract or gastrointestinal illness during the previous winter. They were supplemented daily with either a synbiotic preparation (Lactobacillus helveticus R0052, Bifidobacterium infantis R0033, Bifidobacterium bifidum R0071, and fructooligosaccharide) or a matched placebo for 3 months. Over this period, all emergent health episodes of any type were recorded by parents in a diary. They were checked by investigators at regular monthly visits. The main study outcome was the percentage of children free of any episode during the study course. RESULTS We randomized 135 children (mean age: 4.1±1.0 years) to the synbiotic group (n = 62) or placebo (n = 73) group. At least one illness episode was reported in 32 children in the synbiotic group and 50 in the placebo group (51.6% versus 68.5%). This corresponded to a significant 25% relative risk reduction (95% CI 0.6-44.3%; p = 0.045). This difference was due to a decrease in the number of children who suffered from at least one ENT, respiratory tract or gastrointestinal disorder (50.0% with synbiotic versus 67.1% with placebo; p = 0.044). At least one sickness school day loss was noted in 25.8% of children with the synbiotic as compared with 42.5% with placebo (p = 0.043). No treatment related side effects were detected in either group. CONCLUSIONS This study suggests that a 3-month supplementation with this synbiotic preparation can decrease the risk of occurrence of common infectious diseases in children and limits the risk of school day loss.