scholarly journals Rapid Reduction of Campylobacter Species in the Gut Microbiome of Preschool Children after Oral Azithromycin: A Randomized Controlled Trial

2020 ◽  
Vol 103 (3) ◽  
pp. 1266-1269
Author(s):  
Armin Hinterwirth ◽  
Ali Sié ◽  
Boubacar Coulibaly ◽  
Lucienne Ouermi ◽  
Clarisse Dah ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preschool Children ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Rapid Reduction ◽  
Randomized Controlled ◽  
Campylobacter Species ◽  
Oral Azithromycin

scholarly journals Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edward C. Deehan ◽  
Eloisa Colin-Ramirez ◽  
Lucila Triador ◽  
Karen L. Madsen ◽  
Carla M. Prado ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Combination Therapy ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Metabolic Effects ◽  
Microbiota Composition ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

Inhaled corticosteroids for recurrent respiratory symptoms in preschool children in general practice: Randomized controlled trial

2008 ◽  
Vol 21 (1) ◽  
pp. 88-97 ◽  
Author(s):  
Siebrig Schokker ◽  
Elisabeth M.W. Kooi ◽  
Tjalling W. de Vries ◽  
Paul L.P. Brand ◽  
Paul G.H. Mulder ◽  
...  
Keyword(s):  
General Practice ◽  
Randomized Controlled Trial ◽  
Preschool Children ◽  
Respiratory Symptoms ◽  
Inhaled Corticosteroids ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Daily consumption of pro-vitamin A biofortified (yellow) cassava improves serum retinol concentrations in preschool children in Nigeria: a randomized controlled trial

2020 ◽  
Vol 113 (1) ◽  
pp. 221-231
Author(s):  
Ibukun Afolami ◽  
Martin N Mwangi ◽  
Folake Samuel ◽  
Erick Boy ◽  
Paul Ilona ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preschool Children ◽  
Vitamin A ◽  
Controlled Trial ◽  
Asymptomatic Malaria ◽  
Serum Retinol ◽  
Daily Consumption ◽  
Randomized Controlled ◽  
Vitamin A Status ◽  
Β Carotene

ABSTRACT Background Vitamin A deficiency is a public health problem in sub-Saharan Africa. Pro-vitamin A biofortified (yellow) cassava has the potential to contribute significantly to improve vitamin A status, especially in populations that are difficult to reach with other strategies. Objectives The study aimed at determining the efficacy of biofortified cassava to improve vitamin A status of Nigerian preschool children. Methods An open-label randomized controlled trial was conducted in southwestern Nigeria. In total, 176 preschool children (aged 3–5 y) were randomized into 2 parallel arms comprising an experimental group (n = 88), fed foods prepared from biofortified (yellow) cassava, and a control group (n = 88), fed foods prepared from white cassava, twice a day, 6 d a week for 93 d. Results A total of 159 children completed the trial (yellow cassava group, n = 80; white cassava group, n = 79). Children consumed 221 and 74 µg/d retinol activity equivalents from intervention foods in the yellow and white cassava groups, respectively. The treatment effect on serum retinol concentrations at the end of the feeding trial was 0.06 µmol/L (95% CI: 0.004, 0.124 µmol/L), after adjustment for baseline retinol concentrations, inflammation, and asymptomatic malaria status. No significant treatment effects were detected for serum β-carotene (adjusted effect: 3.9%; 95% CI: −0.6%, 8.6%) and gut permeability (adjusted effect: 0.002; 95% CI: −0.089, 0.092), but a significant effect was detected for hemoglobin concentrations (adjusted effect: 3.08 g/L; 95% CI: 0.38, 5.78 g/L). Conclusions Daily consumption of β-carotene from biofortified cassava improved serum retinol and hemoglobin concentrations modestly in Nigerian preschool children. This study was registered with clinicaltrials.gov as NCT02627222.

scholarly journals Pediatric Tuina for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children: Study Protocol for a Pilot Randomized Controlled Trial

2020 ◽  
Author(s):  
Shu Cheng Chen ◽  
Juan Yu ◽  
Lorna Kwai-Ping Suen ◽  
Yan Sun ◽  
Ya Zheng Pang ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomized Controlled Trial ◽  
Preschool Children ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Online Training ◽  
Adhd Symptoms ◽  
Hyperactivity Disorder ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background: Medication and behavior therapy are the conventional treatments for attention deficit hyperactivity disorder (ADHD), but they have limitations for preschool children. Evidence suggests that pediatric tuina, which is a modality of traditional Chinese medicine, might have beneficial effects on this condition.Objective: To assess the feasibility of conducting an RCT in terms of recruitment, use and acceptability of the parent-administered pediatric tuina for ADHD symptoms in preschoolers.Methods: It is a single-center, two-arm, parallel, open-label, pilot randomized controlled trial (RCT). Sixty children with pre-specified ADHD symptoms (hyperactivity, anxiety, and sleep disturbance) together with one of their parents will be recruited and randomized into two groups at a 1: 1 ratio. Parents in the parent-administered tuina group (intervention group, n=30) will attend an online training program to learn pediatric tuina skills for ADHD symptoms and conduct this treatment on their children at home. Parents in the parent-child interaction group (comparison group, n=30) will attend an online training about progressive muscle relaxation exercise and do this exercise with their children at home. Additional teaching materials will be provided to the participants in both groups. Both interventions should be carried out every other day during a 2-month treatment period, with each time around 20 minutes. Assessment will be performed at baseline, week4, and week 8. The primary outcome measure is the Swanson, Nolan and Pelham Parent Scale; the secondary outcomes include Preschool Anxiety Scale, Children's Sleep Habits Questionnaire, and Parental Stress Scale. A process evaluation embedded within the outcome evaluation will be performed. Differences in the scale scores and test parameters between groups will be examined using a linear mixed-effects model. Qualitative data will be analyzed using thematic content analysis, facilitated by QSR NVivo.Discussion: This study will provide evidence on the acceptability and feasibility of pediatric tuina for ADHD in preschool children. The process evaluation will help to better understand the facilitators and barriers of the intervention functioning.Trial registration: The study was registered at ClinicalTrials.gov (Identifier: NCT04237259) on 14 February 2020.Protocol version: 2, date June 23, 2020

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