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Meta-analyses of previous randomised controlled trials concluded that the smooth muscle relaxant drugs tamsulosin and nifedipine assisted stone passage for people managed expectantly for ureteric colic, but emphasised the need for high-quality trials with wide inclusion criteria. We aimed to fulfil this need by testing effectiveness of these drugs in a standard clinical care setting. For this multicentre, randomised, placebo-controlled trial, we recruited adults (aged 18–65 years) undergoing expectant management for a single ureteric stone identified by CT at 24 UK hospitals. Participants were randomly assigned by a remote randomisation system to tamsulosin 400 μg, nifedipine 30 mg, or placebo taken daily for up to 4 weeks, using an algorithm with centre, stone size (≤5 mm or >5 mm), and stone location (upper, mid, or lower ureter) as minimisation covariates. Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants who did not need further intervention for stone clearance within 4 weeks of randomisation, analysed in a modified intention-to-treat population defined as all eligible patients for whom we had primary outcome data. This trial is registered with the European Clinical Trials Database, EudraCT number 2010-019469-26, and as an International Standard Randomised Controlled Trial, number 69423238. Between Jan 11, 2011, and Dec 20, 2013, we randomly assigned 1167 participants, 1136 (97%) of whom were included in the primary analysis (17 were excluded because of ineligibility and 14 participants were lost to follow-up). 303 (80%) of 379 participants in the placebo group did not need further intervention by 4 weeks, compared with 307 (81%) of 378 in the tamsulosin group (adjusted risk difference 1·3% [95% CI −5·7 to 8·3]; p=0·73) and 304 (80%) of 379 in the nifedipine group (0·5% [–5·6 to 6·5]; p=0·88). No difference was noted between active treatment and placebo (p=0·78), or between tamsulosin and nifedipine (p=0·77). Serious adverse events were reported in three participants in the nifedipine group (one had right loin pain, diarrhoea, and vomiting; one had malaise, headache, and chest pain; and one had severe chest pain, difficulty breathing, and left arm pain) and in one participant in the placebo group (headache, dizziness, lightheadedness, and chronic abdominal pain). Tamsulosin 400 μg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic. UK National Institute for Health Research Health Technology Assessment Programme.

The human intestinal microbiota, establishing a symbiotic relationship with the host, plays a significant role for human health. It is also well known that a disease status is frequently characterized by a dysbiotic condition of the gut microbiota. A probiotic treatment can represent an alternative therapy for enteric disorders and human pathologies not apparently linked to the gastrointestinal tract. Among bifidobacteria, strains of the species Bifidobacterium breve are widely used in paediatrics. B. breve is the dominant species in the gut of breast-fed infants and it has also been isolated from human milk. It has antimicrobial activity against human pathogens, it does not possess transmissible antibiotic resistance traits, it is not cytotoxic and it has immuno-stimulating abilities. This review describes the applications of B. breve strains mainly for the prevention/treatment of paediatric pathologies. The target pathologies range from widespread gut diseases, including diarrhoea and infant colics, to celiac disease, obesity, allergic and neurological disorders. Moreover, B. breve strains are used for the prevention of side infections in preterm newborns and during antibiotic treatments or chemotherapy. With this documentation, we hope to increase knowledge on this species to boost the interest in the emerging discipline known as “therapeutic microbiology”.

The excruciating pain of patients with renal colic on presentation to the emergency department requires effective analgesia to be administered in the shortest possible time. Trials comparing intramuscular non-steroidal anti-inflammatory drugs with intravenous opioids or paracetamol have been inconclusive because of the challenges associated with concealment of randomisation, small sample size, differences in outcome measures, and inadequate masking of participants and assessors. We did this trial to develop definitive evidence regarding the choice of initial analgesia and route of administration in participants presenting with renal colic to the emergency department. In this three-treatment group, double-blind, randomised controlled trial, adult participants (aged 18–65 years) presenting to the emergency department of an academic, tertiary care hospital in Qatar, with moderate to severe renal colic (Numerical pain Rating Scale ≥4) were recruited. With the use of computer-generated block randomisation (block sizes of six and nine), participants were assigned (1:1:1) to receive diclofenac (75 mg/3 mL intramuscular), morphine (0·1 mg/kg intravenous), or paracetamol (1 g/100 mL intravenous). Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants achieving at least a 50% reduction in initial pain score at 30 min after analgesia, assessed by intention-to-treat analysis and per-protocol analysis, which included patients where a calculus in the urinary tract was detected with imaging. This trial is registered with ClinicalTrials.gov, number NCT02187614. Between Aug 5, 2014, and March 15, 2015, we randomly assigned 1645 participants, of whom 1644 were included in the intention-to-treat analysis (547 in the diclofenac group, 548 in the paracetemol group, and 549 in the morphine group). Ureteric calculi were detected in 1316 patients, who were analysed as the per-protocol population (438 in the diclofenac group, 435 in the paracetemol group, and 443 in the morphine group). The primary outcome was achieved in 371 (68%) patients in the diclofenac group, 364 (66%) in the paracetamol group, and 335 (61%) in the morphine group in the intention-to-treat population. Compared to morphine, diclofenac was significantly more effective in achieving the primary outcome (odds ratio [OR] 1·35, 95% CI 1·05–1·73, p=0·0187), whereas no difference was detected in the effectiveness of morphine compared with intravenous paracetamol (1·26, 0·99–1·62, p=0·0629). In the per-protocol population, diclofenac (OR 1·49, 95% CI 1·13–1·97, p=0·0046) and paracetamol (1·40, 1·06–1·85, p=0·0166) were more effective than morphine in achieving the primary outcome. Acute adverse events in the morphine group occurred in 19 (3%) participants. Significantly lower numbers of adverse events were recorded in the diclofenac group (7 [1%] participants, OR 0·31, 95% CI 0·12–0·78, p=0·0088) and paracetamol group (7 [1%] participants, 0·36, 0·15–0·87, p=0·0175) than in the morphine group. During the 2 week follow-up, no additional adverse events were noted in any group. Intramuscular non-steroidal anti-inflammatory drugs offer the most effective sustained analgesia for renal colic in the emergency department and seem to have fewer side-effects. Hamad Medical Corporation Medical Research Center, Doha, Qatar.

In our study, we planned to investigate the efficacy of intradermal sterile water injections (ISWI) in the pain management of patients admitted to the emergency department due to renal colic. We also aimed to investigate patient satisfaction and reduce the use of opioid drugs with this method. A randomized controlled trial was conducted with 100 patients who presented with renal colic. Patients were divided into two groups: Group 1 received 50 mg of intravenous dexketoprofen trometamol, while Group 2 received dexketoprofen trometamol along with ISWI administered to four predetermined dermatomes (T11–L4). Pain levels were assessed using the Visual Analog Scale (VAS) at baseline and at 5, 10, 15, and 30 min post-treatment. Rescue analgesia requirements were also recorded. The primary outcome was the change in VAS pain score from baseline to 30 min after treatment. ISWI combined with dexketoprofen trometamol significantly reduced VAS scores compared to dexketoprofen trometamol alone (p < 0.05). The study was not registered, and the outcome assessment was not blinded. CONSORT methodology was not fully followed. These limitations need to be considered when interpreting the results. The combination of ISWI and dexketoprofen trometamol provides superior pain relief and reduces the need for rescue analgesia in patients with renal colic compared to dexketoprofen trometamol alone. However, because of the limitations mentioned above, no definitive conclusions can be drawn from this study.

Infantile colic (IC) is a functional gastrointestinal disorder characterized by crying spells lasting more than 3 hours a day, more than 3 days a week, for 3 weeks, according to the Rule of Three's. This study aimed to evaluate the effect of added probiotic supplementation in the mother's diet on the crying frequency of babies with infantile colic, maternal attachment, and maternal quality of life. 36 mothers and their babies were randomized into two groups. A probiotic drink containing (Bifidus ActiRegularis (5x108) strain was added to the mothers' diet in the experimental group once a day for 15 consecutive days. The control group received non-pharmaceutical standard care treatment. Data were collected using \"Data Collection Form\", \"Baby Diary Form\", \"Mother Attachment Scale\", and \"Postpartum Quality of Life Scale\". The Baby Diary Form was recorded by the mothers for 15 days. The Mother Attachment Scale\" and \"Postpartum Quality of Life Scale\" were evaluated twice, at the beginning and the first month. The probiotic supplement added to the mothers' diet reduced the crying intensity of babies (P < .05). There was a statistically significant difference between the experimental and control groups in the post-treatment quality of life scores (P < .05). As a result, there is a statistically significant difference between the pre- and post-intervention maternal attachment scores in the intervention group (P < .05). In babies treated with probiotics added to the maternal diet for 15 days, a decrease in crying frequency and an increase in maternal attachment and life quality scores were observed. NCT04374955.

Introduction: To investigate the effectiveness and the safety of a probiotic-mixture (Vivomixx®, Visbiome®, DeSimone Formulation®; Danisco-DuPont, Madison, WI, USA) for the treatment of infantile colic in breastfed infants, compared with a placebo. Methods: A randomized, double-blind, placebo-controlled trial was conducted in exclusively breastfed infants with colic, randomly assigned to receive a probiotic-mixture or a placebo for 21 days. A structured diary of gastrointestinal events of the infants was given to the parents to complete. Samples of feces were also collected to evaluate microbial content and metabolome using fecal real-time polymerase chain reaction (qPCR) and Nuclear magnetic resonance (NMR)-based analysis. Study registered at ClinicalTrials.gov (NCT01869426). Results: Fifty-three exclusively-breastfed infants completed three weeks of treatment with a probiotic-mixture (n = 27) or a placebo (n = 26). Infants receiving the probiotic-mixture had less minutes of crying per day throughout the study by the end of treatment period (68.4 min/day vs. 98.7 min/day; p = 0.001). A higher rate of infants from the probiotic-mixture group responded to treatment (defined by reduction of crying times of ≥50% from baseline), on day 14, 12 vs. 5 (p = 0.04) and on day 21, 26 vs. 17 (p = 0.001). A higher quality of life, assessed by a 10-cm visual analogue scale, was reported by parents of the probiotic-mixture group on day 14, 7.1 ± 1.2 vs. 7.7 ± 0.9 (p = 0.02); and on day 21, 6.7 ± 1.6 vs. 5.9 ± 1.0 (p = 0.001). No differences between groups were found regarding anthropometric data, bowel movements, stool consistency or microbiota composition. Probiotics were found to affect the fecal molecular profile. No adverse events were reported. Conclusions: Administration of a probiotic-mixture appears safe and reduces inconsolable crying in exclusively breastfed infants.

BackgroundThe pain of renal colic, mediated in part by ureteral spasm and inflammation, is often severe and difficult to control. Salbutamol has been shown to cause ureteral relaxation, but its effects on the pain of renal colic have never been studied. The objective of this trial was to investigate whether the use of intravenous salbutamol in addition to standard analgesia was associated with greater pain reduction compared with standard analgesia alone in patients presenting to emergency departments (EDs) with renal colic.MethodsThis single-centre, double-blind, phase II, randomised, placebo-controlled trial recruited adult (≥18 years) ED patients with clinically suspected renal colic. Participants were randomised in a 1:1 ratio to receive either 250 µg of intravenous salbutamol or a placebo (0.9% sodium chloride). The primary outcome was the difference in the change in pain scores (measured on a 100 mm Visual Analogue Scale) from baseline to 30 min following trial treatment administration in participants with subsequently confirmed renal colic. A modified intention-to-treat analysis was undertaken for the primary population of participants with confirmed renal colic.ResultsConsent was obtained from 151 patients; 108 participants with confirmed renal colic were included in the primary outcome analysis. There was no statistical difference between groups in median change in pain score at 30 min (salbutamol group −18 mm (IQR −25 to −3), placebo group −13 mm (IQR −33 to −1), difference 5 mm (95% CI −16 to 6, p=0.575)). No significant differences were found in the secondary outcomes related to pain, patient satisfaction or opiate requirement.More adverse events (AEs) were observed in the salbutamol group (65) compared with placebo (42, p=0.02); no unexpected AEs were identified.ConclusionsThis trial has not identified a clinically or statistically significant benefit from the addition of intravenous salbutamol to standard care for patients presenting to an ED with pain caused by renal colic.Trial registration numbersThe trial was registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), reference 2018-004305-11. It was also registered with the ISRCTN Registry, reference 14552440.

Background Infantile colic is a common problem during the first three months of life. This randomized, double-blind, placebo-controlled trial conducted in an urban hospital in Delhi, India evaluated the efficacy and safety of oral lactase in management of infantile colic. Methods One hundred sixty-two clinically healthy infants aged < 5 months age [mean (SD) = 63.5 (30.5) days] fulfilling the Rome-IV diagnostic criteria for infantile colic were enrolled. Eligible children were randomly allocated to receive 5 drops of lactase (600 FCC units/mL) ( n  = 80) or placebo ( n  = 82) mixed with breast milk or formula feed four times a day for a duration of 4 weeks. Primary outcomes were duration of crying or fussing (min/d), and number of days with colic lasting > 3 h/d; secondary outcomes were parental satisfaction and adverse events. Results At the end of four weeks, mean (SD) crying or fussing time (min/d) was significantly shorter in infants receiving lactase in comparison to placebo [89.9 (115.2) vs .178.5 (153.2); P  = 0.001]. The mean (SD) number of days with colic was also significantly less in the lactase group as compared to placebo group at the end of the treatment [12.1 (7.8) vs 17.6 (8.4); P  < 0.001]. By the end of 4 th week, parental satisfaction in terms of infant’s mood, activity, alertness, comfort and oral intake was better in intervention group. The adverse event profile was comparable between two groups. Conclusions Oral lactase treatment in infantile colic results in symptomatic relief in terms of shortening of duration of crying or fussing, and better parental satisfaction. Trial registration Clinical trial registry of India (CTRI/2017/12/010930) registered on 20/12/2017.

Background Renal colic is the pain experienced by a patient when a renal calculus (kidney stone) causes partial or complete obstruction of part of the renal outflow tract. The standard analgesic regimes for renal colic are often ineffective; in some studies, less than half of patients achieve complete pain relief, and a large proportion of patients require rescue analgesia within 4 h. Current analgesic regimes are also associated with significant side effects including nausea, vomiting, drowsiness and respiratory depression. It has been hypothesised that beta adrenoreceptor agonists, such as salbutamol, may reduce the pain of renal colic. They have been shown to impact a number of factors that target the physiological causes of pain in renal colic (ureteric spasm and increased peristalsis, increased pressure at the renal pelvis and prostaglandin release with inflammation). There is biological plausibility and a body of evidence sufficient to suggest that this novel treatment for the pain of renal colic should be taken to a phase II clinical trial. The aim of this trial is to test whether salbutamol is an efficacious analgesic adjunct when added to the standard analgesic regime for patients presenting to the ED with subsequently confirmed renal colic. Methods A phase II, randomised, placebo-controlled trial will be performed in an acute NHS Trust in the East Midlands. Patients presenting to the emergency department with pain requiring IV analgesia and working diagnosis of renal colic will be randomised to receive standard analgesia ± a single intravenous injection of Salbutamol. Secondary study objectives will explore the feasibility of conducting a larger, phase III trial. Discussion The trial will provide important information about the efficacy of salbutamol as an analgesic adjunct in renal colic. It will also guide the development of a definitive phase III trial to test the cost and clinical effectiveness of salbutamol as an analgesic adjunct in renal colic. Salbutamol benefits from widespread use across the health service for multiple indications, extensive staff familiarity and a good side effect profile; therefore, its potential use for pain relief may have significant benefits for patient care. Trial registration ISRCTN Registry ISRCTN14552440 . Registered on 22 July 2019