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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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Abstract
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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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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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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Abstract
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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Gastrointestinal side effects in liver transplant recipients taking enteric-coated mycophenolate sodium vs. mycophenolate mofetil.
Lopez-Solis, R, DeVera, M, Steel, J, Fedorek, S, Sturdevant, M, Hughes, C, Humar, A
Clinical transplantation. 2014;(7):783-8
Abstract
In the setting of liver transplantation, mycophenolate mofetil (MMF) may be used as an adjuvant therapy for immunosuppression to prevent graft rejection; however, its use may be limited due to severe gastrointestinal (GI) side effects. In contrast, enteric-coated mycophenolate sodium (EC-MPS) may be associated with less severe side effects and hence better tolerability. We compared the side effects of EC-MPS to MMF in liver transplant patients in a de novo study (Study I-randomized, prospective, double-blinded) and a conversion study (Study II). In both studies, the severity of GI symptoms was assessed at various time points using the Gastrointestinal Symptoms Rating Scale (GSRS) survey, a validated survey of GI symptoms (abdominal pain, reflux, indigestion, diarrhea, and constipation). In Study I, the symptoms of 30 recipients receiving EC-MPS (n = 15) were compared to 15 recipients receiving MMF. A multivariate analysis of variance (MANOVA) of the total GSRS scores and symptom syndrome subscores revealed no significant difference (p > 0.05) between the two medications over time. A conversion study (Study II) with 29 participants, however, showed that over time, all GI symptoms improved significantly (p < 0.001) when the patients were treated with EC-MPS instead of MMF.
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Early detection of coagulation abnormalities in patients at nutritional risk: the novel role of thromboelastography.
Xu, Z, Li, Y, Yang, X, Wang, J, Li, J
The American surgeon. 2014;(1):81-6
Abstract
It is believed that malnutrition is common among hospitalized patients and associated with increased risk of morbidity and mortality. It is unclear if it is more likely to cause coagulation disorders in patients with malnutrition. We, therefore, investigate the feasibility of using thromboelastography (TEG) in early detection of coagulation abnormalities in patients at nutritional risk. Fifty successive adult patients with gastrointestinal disease were prospectively divided into one of two groups according to nutritional risk score (less than 3 and 3 or greater). Blood samples were collected at admission for analysis of standard biochemical parameters, routine coagulation tests, and TEG parameters. A total of 62 per cent of patients (n = 31) were at nutritional risk. Serum concentrations of prealbumin, transferrin, total protein, low-density lipoprotein, high-density lipoprotein, and cholesterol were much lower in the nutritional risk group than in the no-risk group (P ≤ 0.05). There was no significant difference in routine coagulation tests, whereas most of the TEG parameters showed significant differences between the two groups. The overall coagulation function was worse in patients at nutritional risk than in patients with good nutritional status (P ≤ 0.01). TEG appears to be more sensitive for the detection of coagulation abnormalities compared with routine coagulation tests in patients at nutritional risk. The phenomenon described in this article should be useful in further studies of patients with malnutrition.
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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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[Effect of fried bacon and parsley sauce on gastrointestinal symptoms in healthy old boys footballer].
Grønbæk, H, Jensen, MP
Ugeskrift for laeger. 2012;(49):3074-8
Abstract
INTRODUCTION Knowledge of the importance of diet on gastrointestinal function and symptoms is generally poorly. In recent years, The New Nordic Food Culture is suggested to have favourable effects. Unfortunally there are huge waiting lists at the most popular restaurants, so we investigated the more traditional "Nordic kitchen". There are no previous studies concerning intake of fried bacon and parsley sauce (FBPS) in healthy middle-aged footballers. MATERIAL AND METHODS Non-blinded, non-randomized, crossover study with a questionnaire survey of 18 healthy old boys footballers before and after FBPS intake. Ten players responded to the questionnaire, including one who was not exposed to FBPS. RESULTS The median intake was 15 pieces of fried bacon (range 12-23), 1.5 dl parsley sauce (range 1-5 dl), and eight potatoes (range 6-30), but no dessert. We found a significantly increased stool frequency and a trend towards change in consistency compared to baseline. We found increased abdominal pain and a decrease in general well-being, but could not demonstrate any impact on complaints from the family. CONCLUSION In otherwise healthy old boys footballers the FBPS diet has great impact on a range of gastrointestinal symptoms. FBPS affected stool frequency and abdominal pain, but caused no effect on family complaints. We cannot exclude a dose-response effect or a gender/age phenomenon; and we suggest supplemental dose-response studies and studies including women of all ages. Further, we recommend a detailed dietary assessment before referring patients with gastrointestinal symptoms for invasive procedures like colonoscopy or CT-scanning. TRIAL REGISTRATION none FUNDING none.
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Longitudinal analysis of genitourinary and bowel symptoms in prostate cancer patients following brachytherapy.
Eckman, MH, Ying, J, Hertzfeld, K, Kumar, N, Barrett, W
American journal of clinical oncology. 2010;(1):1-10
Abstract
OBJECTIVES Multiple options with similar cure rates exist for men with localized adenocarcinoma of the prostate. Therefore, treatment-related morbidity is a major consideration for treatment selection. We present a descriptive, longitudinal analysis of genitourinary and bowel symptoms following treatment in a brachytherapy registry at the University of Cincinnati. METHODS Between 1995 and 2007, 394 consecutive patients with newly diagnosed early stage prostate cancer underwent radioactive (125)I seed implantation. Patients were followed for an average of 5.0 +/- 3.1 years. Follow-up data regarding genitourinary and bowel symptoms and clinical/biochemical evidence of cancer recurrence were collected during posttreatment visits. RESULTS Forty percent of men developed urinary obstructive symptoms, generally within the first 3 to 6 months following brachytherapy. These symptoms resolved in a large proportion of men. Impaired potency occurred in 15% of men by 6 months and in more than 40% of men by 60 months. Bowel symptoms were less common and had a slower onset. CONCLUSION Symptoms following brachytherapy each have their own temporal pattern for development and resolution. These patterns are well explained by the underlying pathophysiology of therapeutic radiation injury and healing. Men and their partners can use this information to guide and inform treatment decisions.
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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.