scholarly journals The Effects of a Partially Hydrolyzed Formula with Low Lactose and Probiotics on Mild Gastrointestinal Disorders of Infants: A Single-Armed Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 3371
Author(s):  
Yongying Huang ◽  
Yubo Zhou ◽  
Hongtian Li ◽  
Yipu Chen ◽  
Yingchao Mu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Primary Outcome ◽  
Gastrointestinal Symptom ◽  
Growth Parameters ◽  
Gastrointestinal Symptoms ◽  
Gastrointestinal Disorders ◽  
Term Infants ◽  
Gastrointestinal Health ◽  
Hydrolyzed Formula ◽  
Feeding Interventions

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

scholarly journals Who uses probiotics and why? A survey study conducted among general gastroenterology patients

2021 ◽  
Vol 8 (1) ◽  
pp. e000742
Author(s):  
Elissa Lynch ◽  
Jordan Troob ◽  
Benjamin Lebwohl ◽  
Daniel E Freedberg
Keyword(s):  
Gastrointestinal Symptom ◽  
Gastrointestinal Symptoms ◽  
Sociodemographic Factors ◽  
Cross Sectional Study ◽  
Survey Study ◽  
Free Text ◽  
Academic Hospital ◽  
Cross Sectional ◽  
Gastrointestinal Health ◽  
Paper Survey

BackgroundThe rapid growth of the probiotic industry suggests patients will continue to seek advice from gastroenterologists about probiotics. To best address patient questions and concerns, we must first understand who uses probiotics and why.MethodsThis was a cross-sectional study conducted in the endoscopy suite of an academic hospital from June to October of 2019. Surveys were anonymous and contained a combination of multiple choice, free text and Likert scale questions. Participants privately completed a paper survey in English or Spanish and the results were reviewed with them by study personnel to clarify responses. Descriptive statistics were generated and multivariable logistic regression modelling was used to compare characteristics of probiotic users versus non-users.ResultsDuring the 5-month study period, 600 patients were approached and 537 (90%) agreed to participate. Among participants, 89% completed at least 24 survey items and were included in the analysis. Overall, 27% of patients reported probiotic use. Bloating, rather than diarrhoea, was the main gastrointestinal symptom associated with use of probiotics (aOR 2.59, 95% CI 1.52 to 4.44 for bloating; aOR 1.03, 95% CI 0.55 to 1.94 for diarrhoea). Frequent reasons cited for taking probiotics were the beliefs that they improved overall health and longevity (54%) and that they improved gastrointestinal symptoms (45%).ConclusionsProbiotic use is common among general gastroenterology patients, many of whom believe that probiotics confer general rather than specific gastrointestinal health benefits. Symptoms—especially bloating—and not sociodemographic factors seem to motivate probiotic use. By understanding patient expectations for probiotics, clinicians can better advise them.

Efficacy of Soy-Based Formulas in Alleviating Gastrointestinal Symptoms in Infants With Milk-Based Formula Intolerance: A Randomized Clinical Trial

2020 ◽  
pp. 000992282097301
Author(s):  
John B. Lasekan ◽  
Geraldine E. Baggs
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Randomized Clinical Trial ◽  
Gastrointestinal Symptoms ◽  
Milk Formula ◽  
Term Infants ◽  
Healthy Infants ◽  
Pilot Clinical Study ◽  
Poor Tolerance ◽  
Reference Cohort

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.

scholarly journals Growth, Tolerance, and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula with Added 2′-FL Fucosyllactose (2′-FL) Human Milk Oligosaccharide

Nutrients ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 186
Author(s):  
Carlett Ramirez-Farias ◽  
Geraldine E. Baggs ◽  
Barbara J. Marriage
Keyword(s):  
Primary Outcome ◽  
Clinical Symptoms ◽  
Food Protein ◽  
Feeding Intolerance ◽  
Feeding Trial ◽  
Study Results ◽  
Z Scores ◽  
Hydrolyzed Formula ◽  
Intended Use ◽  
Weight For Age

Background: The purpose of this study was to evaluate the growth, tolerance and compliance effects of an extensively hydrolyzed formula with added 2′-FL in an intended use population of infants. Methods: A non-randomized, single-group, multicenter study was conducted. Infants (0–60 days of age) with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an extensively hydrolyzed formula (eHF) was deemed appropriate were enrolled in a 2-month feeding trial. The primary outcome was maintenance of weight for age z-score during the study. Weight, length, head circumference, formula intake, tolerance measures, clinical symptoms and questionnaires were collected. Forty-eight infants were enrolled and 36 completed the study. Results: Weight for age z-scores of infants showed a statistically significant improvement from study day 1 to study day 60 (0.32 ± 0.11, p = 0.0078). Conclusions: Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population.

scholarly journals Prevalence of functional gastrointestinal disorders in infants and young children in China

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ying Huang ◽  
Serene Yaling Tan ◽  
Panam Parikh ◽  
Vanitha Buthmanaban ◽  
Shaman Rajindrajith ◽  
...  
Keyword(s):  
Young Children ◽  
Maternal Education ◽  
Functional Gastrointestinal Disorders ◽  
Gastrointestinal Symptoms ◽  
Functional Constipation ◽  
Gastrointestinal Disorders ◽  
Cross Sectional ◽  
Validated Questionnaire ◽  
Rome Iv ◽  
Infants And Young Children

Abstract Background The prevalence of functional gastrointestinal disorders (FGIDs) in children, particularly from Asia, is largely unknown. There are not many studies done in Asia especially using the Rome IV criteria. The aim of this study is to assess the prevalence of FGIDs in infants and young children in a representative sample in China. Methods A prospective, cross-sectional, community-based survey was conducted among healthy infants and young children between the ages of 0–4 years in Jinhua and Shanghai, China. A total of 2604 subjects (1300 subjects from Jinhua and 1304 subjects from Shanghai) completed a validated questionnaire on pediatric gastrointestinal symptoms. FGIDs in infants and young children were diagnosed using the Rome IV criteria. Results According to the Rome IV criteria, the prevalence of having a FGID in Chinese infants and young children is 27.3%. Infant regurgitation (33.9%) was the most common FGID among the 0–6 months old while functional constipation (7.0%) was the most common among the 1–4 years old. Risk factor analysis revealed that prevalence of infantile colic was higher with better maternal education and low birth weight. Prevalence of infantile regurgitation was significantly greater in males, living in a rural area, being exclusively breast fed at least up to 4 months and starting formula feeds within the first month. The risk of functional constipation was lower for infants who were delivered vaginally. Conclusions Infantile regurgitation was the most common FGID in Chinese infants while functional constipation was most prevalent among young Chinese children. Trial registration Netherlands Trial Registry Identifier: NL6973/NTR7161.

scholarly journals Eosinophilic Gastrointestinal Diseases: Review and Update

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Mahreema Jawairia ◽  
Ghulamullah Shahzad ◽  
Paul Mustacchia
Keyword(s):  
Gastrointestinal Tract ◽  
Clinical Features ◽  
Gastrointestinal Symptoms ◽  
Gastrointestinal Diseases ◽  
Gastrointestinal Disorders ◽  
Diverse Group ◽  
Intestinal Diseases ◽  
Gastrointestinal Inflammation ◽  
Eosinophilic Gastrointestinal Disorders

Eosinophilic gastrointestinal disorders (EGIDs) are a progressively more frequent diverse group of intestinal diseases. The intention of this paper is to present the newest developments in the care of patients with EGIDs and to sum up a rising literature defining the clinical features and mechanistic elements of eosinophils and their intricate associations with the gastrointestinal tract. Clinicians ought to stay sensitive to EGIDs as a diagnostic likelihood for patients with general gastrointestinal symptoms. Further research is warranted to establish various methods leading to dysfunction coupled with eosinophilic gastrointestinal inflammation.

scholarly journals Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial

2014 ◽  
Vol 14 (1) ◽  
Author(s):  
Ita Litmanovitz ◽  
Fabiana Bar-Yoseph ◽  
Yael Lifshitz ◽  
Keren Davidson ◽  
Alon Eliakim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Double Blind ◽  
Term Infants ◽  
High Beta

scholarly journals Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (3) ◽  
pp. e1003415
Author(s):  
María Elvira Balcells ◽  
Luis Rojas ◽  
Nicole Le Corre ◽  
Constanza Martínez-Valdebenito ◽  
María Elena Ceballos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Clearance Rate ◽  
Neutralizing Antibodies ◽  
Statistical Power ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Group Versus ◽  
Hospital Length Of Stay

Background Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. Methods and findings The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32–2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19–2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion. Conclusions In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration. Trial registration NCT04375098.

Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: A randomized clinical trial

2003 ◽  
Vol 142 (6) ◽  
pp. 669-677 ◽  
Author(s):  
Dennis R. Hoffman ◽  
Eileen E. Birch ◽  
Yolanda S. Castañeda ◽  
Sherry L. Fawcett ◽  
Dianna H. Wheaton ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Visual Function ◽  
Term Infants ◽  
Breast Fed ◽  
Long Chain
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