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"Diarrhea - complications"
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Vancomycin, Metronidazole, or Tolevamer for Clostridium difficile Infection: Results From Two Multinational, Randomized, Controlled Trials
Background. Clostridium difficile infection (CDI) is a common complication of antibiotic therapy that is treated with antibiotics, contributing to ongoing disruption of the colonic microbiota and CDI recurrence. Two multinational trials were conducted to compare the efficacy of tolevamer, a nonantibiotic, toxin-binding polymer, with vancomycin and metronidazole. Methods. Patients with CDI were randomly assigned in a 2:1:1 ratio to oral tolevamer 9 g (loading dose) followed by 3 g every 8 hours for 14 days, vancomycin 125 mg every 6 hours for 10 days, or metronidazole 375 mg every 6 hours for 10 days. The primary endpoint was clinical success, defined as resolution of diarrhea and absence of severe abdominal discomfort for more than 2 consecutive days including day 10. Results. In a pooled analysis, 563 patients received tolevamer, 289 received metronidazole, and 266 received vancomycin. Clinical success of tolevamer was inferior to both metronidazole and vancomycin (P < .001), and metronidazole was inferior to vancomycin (P = .02; 44.2% [n = 534], 72.7% [n = 278], and 81.1% [n = 259], respectively). Clinical success in patients with severe CDI who received metronidazole was 66.3% compared with vancomycin, which was 78.5%. (P = .059). A post-hoc multivariate analysis that excluded tolevamer found 3 factors that were strongly associated with clinical success: vancomycin treatment, treatment-naive status, and mild or moderate CDI severity. Adverse events were similar among the treatment groups. Conclusions. Tolevamer was inferior to antibiotic treatment of CDI, and metronidazole was inferior to vancomycin. Trial Registration. clinicaltrials.gov NCT00106509 and NCT00196794.
Journal Article
Study protocol for a prospective, investigator-initiated clinical trial on the vascular effects of acupuncture in the abdomen and lower limbs for patients with diarrhea-predominant irritable bowel syndrome
Background
Physicians classify irritable bowel syndrome with diarrhea symptoms under the label IBS-D which represents a gastrointestinal disorder that meets specific functional diagnostic criteria. Studies show acupuncture helps manage IBS-D symptoms though researchers do not understand if specific treatment points in the abdomen provide better outcomes than standard acupuncture points in the lower body regions. The study investigates the effects acupuncture treatments using local and systemic needling techniques have on IBS-D symptom expression and gut microbial diversity features.
Methods
The study employs a randomized controlled single-blinded exploratory clinical trial design which includes 36 participants diagnosed with IBS-D via Rome IV criteria. Participants are randomly allocated to one of three groups: abdominal acupuncture, lower limb acupuncture, or standard treatment. Participants who receive acupuncture treatment receive eight sessions which are distributed throughout 4 weeks as clinicians activate specific points connected to gastrointestinal function. Lifestyle education and approved medications with symptom management make up the standard treatment provided to participants. The main outcome measures assess IBS Symptom Severity Scale (IBS-SSS) score changes from baseline at Week 5. Additional evaluation measures in this study comprise stool consistency examination alongside patient global assessments and cold-heat surveys along with EQ-5D-5L quality of life assessment and gut microbiota examination as secondary outcomes.
Results
Research has been designed to evaluate how abdominal and lower limb acupuncture techniques compare in symptom relief and microbiota adaptation outcomes. The preliminary data is expected to reveal distinct patterns between local and wide-reaching effects which suggests that IBS-D treatment should be tailored on a personal basis.
Conclusion
The comparison of abdominal and lower limb acupuncture treatment efficacy adds to our understanding of acupuncture therapy benefit for IBS-D. The results will help guide clinical practice and support the creation of tailored acupuncture treatments.
Journal Article
Additional Bicarbonate Infusion Complements WHO Rehydration Therapy in Children with Acute Diarrhea and Severe Dehydration Presenting with Severe Non-anion Gap Metabolic Acidemia: An Open Label Randomized Trial
Objectives
To assess the efficacy and safety of bicarbonate infusion in children with Acute Diarrhea and Severe Dehydration (ADSD) having severe Non-Anion Gap Metabolic Acidemia (sNAGMA).
Methods
Children (aged 1–144 mo) with ADSD and sNAGMA (pH ≤7.2 and/or serum bicarbonate ≤15 mEq/L) were enrolled in an open-label randomized design. Controls (n = 25) received WHO-recommended rehydration therapy with Ringer Lactate, while intervention group (n = 25) received additional bicarbonate deficit correction. Primary outcome was time taken to resolve metabolic acidemia (pH >7.30 and/or bicarbonate >15 mEq/L). Secondary outcome measures were adverse outcome [composite of pediatric intensive care unit (PICU) transfer and deaths], acute care area free days in 5 d (ACAFD
5
), hospital stay, and adverse effects.
Results
Time taken to resolve metabolic acidemia was significantly lesser with intervention [median (IQR); 8 h (4, 12) vs. 12 h (8, 24);
p
= 0.0067]. Intervention led to acidemia resolution in significantly more children by 8 h and 16 h (17/25 vs. 9/25,
p
= 0.035 and 23/25 vs. 17/24,
p
= 0.018, respectively). Patients with fluid refractory shock needed lesser inotropes in intervention group [median Vasoactive Inotrope Score (VIS), 10.5 vs. 34]. Intervention led to significantly lesser adverse outcome (0/25 vs. 5/25,
p
= 0.049), and noticeably more ACAFD
5
[median (IQR); 2 (1, 2) vs. 1 (1, 2);
p
= 0.12]. Two patients died in the control group while none in the intervention group. No adverse effect was documented.
Conclusions
Additional calculated dose of bicarbonate infusion led to significantly early resolution of metabolic acidemia, lesser utilization of critical care facilities, and lesser adverse outcome in children with ADSD and sNAGMA, compared to standard therapy, with no adverse effect.
Journal Article
Predictors of mortality among hospitalized children with severe acute malnutrition: a prospective study from Uganda
BackgroundWe determined the predictors of mortality among children admitted with severe acute malnutrition (SAM).MethodsThis was a prospective study nested in a randomized trial among 6–59-month-old children admitted with SAM. Socio-demographic and medical history data were collected using questionnaires and clinical examination, anthropometry and laboratory tests were performed. They were monitored daily until discharge or death during hospitalization while receiving care according to national guidelines. Predictors of death were assessed using Cox regression.ResultsOf 400 children, 9.8% (n = 39) died during hospitalization. Predictors of mortality included diarrhoea at admission [hazard ratio [HR] 2.19, 95% confidence interval (CI): 1.06; 4.51], lack of appetite [HR 4.50, 95% CI: 1.76; 11.50], suspected sepsis [HR 2.23, 95% CI: 1.18; 4.24] and skin ulcers [HR 4.23, 95% CI: 1.26; 4.17]. Chest indrawing [HR 5.0, 95% CI: 1.53; 16.3], oxygen saturation below 94% [HR 3.92, 95% CI: 1.42; 10.83] and confirmed HIV infection [HR 3.62, 95% CI: 1.69; 7.77] also predicted higher mortality.ConclusionInfections were major contributors to mortality. This underscores the need for improved prevention and management of these infections among children with severe malnutrition.
Journal Article
Predictors of Adherence to Short-Course Probiotics Among Children with Gastroenteritis who are Enrolled in a Clinical Trial
To improve our understanding of adherence to discharge medications in the ED and within research trials, we sought to quantify medication adherence and identify predictors thereof in children with acute gastroenteritis (AGE).
We conducted a secondary analysis of a randomized trial of twice daily probiotic for 5 days. The population included previously healthy children aged 3-47 months with AGE. The primary outcome was patient-reported adherence to the treatment regimen, defined a priori as having received >70% of the prescribed doses. Secondary outcomes included predictors of treatment adherence and concordance between patient-reported adherence and the returned medication sachet counts.
After excluding participants with missing data on adherence, 760 participants were included in this analysis: 383 in the probiotic arm (50.4%); and 377 in the placebo arm (49.6%). Self-reported adherence was similar in both groups (77.0% in probiotic versus 80.3% in placebo). There was good agreement between self-reported adherence and sachet counts (87% within limits of agreement (-2.9 to 3.5 sachets) on the Bland-Altman plots). In the multivariable regression model, covariates associated with adherence were greater number of days of diarrhea post-emergency department visit, and the study site; covariates negatively associated with adherence were age 12-23 months, severe dehydration and greater total number of vomiting and diarrhea episodes after enrolment.
Longer duration of diarrhea and study site were associated with higher probiotic adherence. Age 12-23 months, severe dehydration and greater number of vomiting and diarrhea episodes post enrolment negatively predicted treatment adherence.
Journal Article
Vitamin-D deficiency predicts infections in young north Indian children: A secondary data analysis
Recent studies have demonstrated a relationship between poor vitamin D status and respiratory infections and diarrhea among young children. Acute lower respiratory infections (ALRI) and diarrhea are among the two most important causes of death in under-5 children. In this paper, we examined the extent to which vitamin-D deficiency (<10 ng/ml) predicts ALRI, clinical pneumonia and diarrhea among 6 to 30 months old children.
We used data from a randomized controlled trial (RCT) of daily folic acid and/or vitamin B12 supplementation for six months in 6 to 30 months old children conducted in Delhi, India. Generalized estimating equations (GEE) were used to examine the associations between vitamin-D deficiency and episodes of ALRI, clinical pneumonia and diarrhea.
Of the 960 subjects who had vitamin-D concentrations measured, 331(34.5%) were vitamin-D deficient. We found, after controlling for relevant potential confounders (age, sex, breastfeeding status, wasting, stunting, underweight, anemia status and season), that the risk of ALRI was significantly higher among vitamin-D deficient (OR 1.26; 95% CI: 1.03 to 1.55) compared to vitamin-D-replete children in the six months follow-up period. Vitamin-D status was not associated with episodes of diarrhea or clinical pneumonia.
Vitamin-D deficiency is common in young children in New Delhi and is associated with a higher risk of ALRI. The role of vitamin D in Indian children needs to be elucidated in further studies.
Journal Article
A starch- and sucrose-reduced diet may lead to improvement of intestinal and extraintestinal symptoms in more conditions than irritable bowel syndrome and congenital sucrase-isomaltase deficiency
•A starch- and sucrose-reduced diet decreases gastrointestinal symptoms.•Starch and sucrose reduction diminishes extraintestinal symptoms.•A starch- and sucrose-reduced diet may be efficient in several gastrointestinal diseases.•A starch- and sucrose-reduced diet may lead to higher circulating biomarkers reflecting improved nutrient intake.
A starch- and sucrose-reduced diet has been found to improve gastrointestinal and extraintestinal symptoms in irritable bowel syndrome, as well as reduce weight and improve psychological well-being. Our hypothesis was that a starch- and sucrose-reduced diet would also be beneficial in other conditions with similar symptoms. The aim of the present research letter was to describe the role of a starch- and sucrose-reduced diet in a pilot project in patients with diarrhea having varying causes.
One man, age 36 y, suffering from functional diarrhea and one woman, 56 y, suffering from microscopic colitis, were randomized to a starch- and sucrose-reduced diet for 4 wk. At baseline, dietary information was given, and blood samples collected. Weight and waist circumference were measured. The participants completed the irritable bowel syndrome severity scoring system for evaluating specific gastrointestinal and extraintestinal symptoms and visual analog scale for irritable bowel syndrome for evaluation of specific gastrointestinal symptoms and psychological well-being. The degrees of satiety and sweet craving were measured on visual analog scales. After 4 wk, all procedures were repeated.
Weight, body mass index, and waist circumference were decreased during the intervention. The total amount of gastrointestinal symptoms was decreased in the participants with functional diarrhea, and diarrhea and bloating were decreased in both participants. Both had reduced extraintestinal symptoms and improved psychological well-being. Blood levels had mainly unchanged or slightly increased values of measurements reflecting nutrient intake.
A starch- and sucrose-reduced diet may lead to weight reduction, reduced symptoms, and improved well-being in several patient categories, not only in patients suffering from irritable bowel syndrome. Future randomized trials should be done.
Journal Article
The Usefulness of the Low-FODMAP Diet with Limited Tryptophan Intake in the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
(1) Background: A low-FODMAP diet is often recommended in the treatment of irritable bowel syndrome, but it does not improve abdominal symptoms in all patients, and an alternative diet is desirable. The purpose of this study was to evaluate the efficacy of a low-FODMAP diet with a concomitant reduction in tryptophan (TRP) intake in irritable bowel syndrome with diarrhea predominance (IBS-D) in relation to its metabolism via the serotonin and kynurenine pathways. (2) Methods: 40 healthy people (Group I, Controls) and 80 patients with IBS-D were included in the study. IBS-D patients were randomly divided into two groups of 40 each (Groups IIA and IIB). In Group IIA, the low-FODMAP diet was recommended, while in Group IIB, the same diet was recommended but with limited TRP intake for 8 weeks. The TRP intake was analyzed with the use of the nutritional calculator. Abdominal complaints were assessed using the Gastrointestinal Symptom Rating Scale (GSRS-IBS), and psychological status was simultaneously determined using two scales: the Hamilton Anxiety Scale (HAM-A) and the Hamilton Depression Scale (HAM-D). TRP and its metabolites: 5-hydoxyindoleacetic acid (5-HIAA), kynurenine (KYN), kynurenic acid (KYNA), and quinolinic acid (QA) were measured in urine using liquid chromatography tandem mass spectrometry (LC-MS/MS). (3) Results: The consumption of TRP per mg/kg/b.w./24 h has decreased in Group IIA from 20.9 ± 2.39 to 17.45 ± 2.41 (16.5%) and in Group IIB from 21.3 ± 2.33 to 14.32 (34.4%). Significantly greater improvement was found after nutritional treatment in patients in Group IIB as compared to Group IIA (GSRS score: 38.1% vs. 49.8%; HAM-A: 38.7% vs. 49.9%; HAM-D: 13.8% vs. 35.0%; p < 0.01). Reducing TRP intake showed a negative correlation with the degree of improvement in the GSRS score. (4) Conclusions: Lowering the TRP content in a low-FODMAP diet may be useful in treating IBS-D.
Journal Article
The effect of abdominal massage on enteral nutrition tolerance in patients on mechanical ventilation: A Randomized Controlled Study
To assess whether abdominal massage impacts enteral feeding tolerance in mechanically ventilated patients.
Patients were randomized to receive standard or intervention care (standard care plus a 15-minute abdominal massage twice daily) for three days. We recorded the vomiting, reflux, gastric retention, aspiration, diarrhea, abdominal distension, gastric residual volume and abdominal circumference from days one to three. A P-value of less than 0.05 was statistically significant.
Seventy-four patients (37 per group) were recruited (intervention vs control: age 58.03 ± 10.44 vs 55.33 ± 12.45 years; %M: 69.70 % vs 69.70 %). The aspiration, gastric retention and abdominal distension incidence in the intervention group was 3.03 %, 6.06 % and 9.09 %, whereas in the control group it was 24.24 %, 30.30 % and 27.27 % (P <.05). The vomiting, reflux and diarrhea incidence for patients in the intervention group were all 3.03 %, whereas in the control group they were 3.03 %, 9.09 % and 9.09 % (P >.05). From day 1 to day 3, the gastric residual volume decreased from 87.23 ± 3.29 mL to 72.59 ± 5.40 mL in the intervention group and increased from 91.94 ± 3.45 mL to 105.00 ± 6.94 mL in the control group. Similarly, the abdominal circumference decreased from 84.41 ± 1.73 cm to 82.44 ± 1.73 cm in the intervention group and increased from 87.90 ± 1.60 cm to 88.90 ± 1.75 cm in the control group. The differences in time, group, and interaction effects between the two groups were statistically significant for abdominal circumference and gastric residual volume (P <.05).
Abdominal massage can effectively reduce gastric retention, abdominal distension, aspiration, gastric residual volume and abdominal circumference in mechanically ventilated patients, but not the incidence of vomiting, reflux and diarrhea.
Journal Article