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.

Influence of Feeding Types during the First Months of Life on Calciuria Levels in Healthy Infants: A Secondary Analysis from a Randomized Clinical Trial

2017 ◽  
Vol 70 (2) ◽  
pp. 132-139 ◽  
Author(s):  
Natalia Ferré ◽  
Carmen Rubio-Torrents ◽  
Veronica Luque ◽  
Ricardo Closa-Monasterolo ◽  
Veit Grote ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Dietary Factors ◽  
Calcium Excretion ◽  
Dietary Intakes ◽  
Linear Regression Models ◽  
Term Infants ◽  
Spot Urine ◽  
Feeding Types ◽  
Healthy Infants

Background/Aims: Dietary factors can modify calciuria. We aim to investigate urinary calcium excretion in healthy infants according to their protein. Methods: Secondary data analysis from a randomized clinical trial where healthy term infants were randomized after birth to a higher (HP) or lower (LP) protein content formula that was consumed until age 1 year. A non-randomized group of breastfed (BF) infants was used for reference. Anthropometry, dietary intakes and calciuria (calcium/creatinine ratios) from spot urine samples were assessed at ages 3 and 6 months. At 6 months, the kidney volumes were assessed using ultrasonography, and the serum urea and creatinine levels were determined. Results: BF infants showed the highest calciuria levels, followed by the HP and the LP groups (p < 0.001 for all comparisons). Either protein intakes or formula types modulated the calciuria in linear regression models adjusted for other influencing dietary factors. The usual cut-off values classified 37.8% (BF), 16.8% (HP) and 4.9% (LP) of the infants as hypercalciuric. Conclusions: Feeding types during the first months of life affect calciuria, with BF infants presenting the highest levels. We propose new cut-off values, based on feeding types, to prevent the overestimation in hypercalciuria diagnoses among BF infants.

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

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

Effectiveness of nutritional treatment and synbiotic use on gastrointestinal symptoms reduction in HIV-infected patients: Randomized clinical trial

2017 ◽  
Vol 36 (3) ◽  
pp. 680-685 ◽  
Author(s):  
Annelisa Silva e Alves de Carvalho Santos ◽  
Erika Aparecida da Silveira ◽  
Marianne Oliveira Falco ◽  
Max Weyler Nery ◽  
Marilia Dalva Turchi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Gastrointestinal Symptoms ◽  
Nutritional Treatment

Clinical Outcome of Aspergillus-Specific Cytotoxic T Lymphocytes for Refractory Invasive Aspergillosis in Patients with Hematological Malignancies.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2215-2215 ◽  
Author(s):  
Tong Wu ◽  
Chun-Rong Tong ◽  
Xing-Yu Cao ◽  
Jing-Bo Wang ◽  
Lung-Ji Chang ◽  
...  
Keyword(s):  
Clinical Study ◽  
T Lymphocytes ◽  
Invasive Aspergillosis ◽  
Cytotoxic T Lymphocytes ◽  
Hematological Malignancies ◽  
Antifungal Agents ◽  
Cytotoxic T Lymphocyte ◽  
Complete Response ◽  
Pilot Clinical Study ◽  
Poor Tolerance

Abstract Invasive aspergillosis has high mortality in patients with hematological malignancies after chemotherapy or allogeneic stem cell transplantation (SCT) due to usually low response rate to current antifungal agents and relatively poor tolerance to the toxicities of the antifungal medicines. In this pilot clinical study, we explore to manage the patients with refractory invasive aspergillosis with aspergillus-specific cytotoxic T lymphocytes (aspergillus CTL). Ten patients who were either no longer response to antifungal medicines or have to stop antifungal agents due to severe toxicities were included in this clinical study. Diagnosis are ALL (2 cases), AML (5 cases), and CML (3 cases). The median age was 37 (10 to 62) years old. Seven of them received allogeneic SCT (unrelated 3 cases, haploidentical 3 cases, identical sibling 1 case), and 3 patients were after chemotherapy. Aspergillus CTLs were either donor origin (5 cases) or patient origin (5 cases) if original donor was not available. Patients received 1 to 3 infusions of aspergillus CTLs. The median CTLs infused were 3.61 (0.28–40.00) x 105/kg. No infusion-related reactions were noted. No pre-existed graft-versus-host disease deteriorated. With aspergillus CTL therapy, one of them (10%) achieved complete response, 6 patients (60%) improved significantly, 1 case was stable, and 2 patients became worse. Our preliminary data has shown that aspergillus-specific cytotoxic T lymphocyte is a safe and promising mean to manage refractory invasive aspergillosis in patients with hematological malignancies.

Bioreconstructive Poly-L/D-Lactide Implant Compared With Swanson Prosthesis in Metacarpophalangeal Joint Arthroplasty in Rheumatoid Patients: a Randomized Clinical Trial

2010 ◽  
Vol 35 (9) ◽  
pp. 746-753 ◽  
Author(s):  
P.B. Honkanen ◽  
R. Thonen ◽  
E.T. Skyttä ◽  
M. Ikävalko ◽  
M.U.K. Lehto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Randomized Clinical Trial ◽  
Joint Destruction ◽  
Metacarpophalangeal Joint ◽  
Joint Arthroplasty ◽  
Silicone Implant ◽  
Clinical Assessments ◽  
Randomized Clinical Study

It was hypothesized that the bioresorbable interposition implant might offer a viable alternative to conventional silicone implant arthroplasty in rheumatoid metacarpophalangeal joint destruction. A randomized clinical study was performed to compare a stemless poly-L/D-lactide copolymer 96: 4 (PLDLA) implant with the Swanson silicone implant. Results in 52 patients (53 hands and 175 joints) at a mean follow-up of 2 years (minimum 1 year) showed that the improvement in clinical assessments was comparable in both groups, except for better maintenance of palmar alignment in the Swanson group. The lack of implant fractures and intramedullary osteolysis were advantages of the PLDLA implant. The bioresorbable PLDLA interposition implant may offer an alternative tool for tailored reconstruction of rheumatoid metacarpophalangeal joints.

scholarly journals Fecal S100A12 in Healthy Infants and Children

2013 ◽  
Vol 35 ◽  
pp. 295-299 ◽  
Author(s):  
A. S. Day ◽  
M. Ehn ◽  
R. B. Gearry ◽  
D. A. Lemberg ◽  
S. T. Leach
Keyword(s):  
Young Children ◽  
Elevated Level ◽  
Gastrointestinal Symptoms ◽  
Infants And Children ◽  
Healthy Children ◽  
Term Infants ◽  
Healthy Infants ◽  
Stool Samples ◽  
Serial Samples ◽  
In Infants And Children

Background and Aims. Fecal S100A12 is shown to be a useful noninvasive marker of gut inflammation. However, the studies to date have not characterised the patterns of expression in healthy young children. This study aimed to determine S100A12 levels in infants and children without symptoms of underlying gut disease.Methods. Stool samples were collected from healthy infants (<12 months) and children without gastrointestinal symptoms. Faecal S100A12 was measured by immunoassay.Results. Fifty-six children were recruited. Serial samples were obtained from seven term infants over the first 6 months of life. Single samples were obtained from 49 healthy children ranging from 0.16 to 13.8 years of age. Median S100A12 levels were 0.5 mg/kg (ranging from 0.39 to 25) in the healthy children, with high values (>10 mg/kg) in five infants only. There was no variation between gender. Median S100A12 levels in healthy infants remained below the established normal cut-off from birth to six months of age.Conclusion. S100A12 levels in well infants and children are almost exclusively lower than the standard cut-off. Transiently higher levels may be seen in early infancy. An elevated level of S100A12 in children older than 12 months of age is likely to represent organic gut disease.

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

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