Role of Racecadotril in Children with Acute Diarrhea

2021 ◽  
Vol 36 (1) ◽  
pp. 8-13
Author(s):  
Azmeri Sultana ◽  
Parijat Bishwas ◽  
Shahidul Islam ◽  
Uzzal Kumar Ghosh ◽  
Kazi Iman ◽  
...  
Keyword(s):  
Placebo Group ◽  
Acute Diarrhea ◽  
Watery Diarrhea ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Safe Treatment ◽  
Oral Rehydration ◽  
Acute Watery Diarrhea ◽  
Adults And Children

Background: Diarrhea is a leading cause of illness and death among children in developing countries. Racecadotril (acetorphan), an enkephalinase inhibitor with antisecretory and anti-diarrheal actions, is an effective and safe treatment for acute diarrhea in adults and children. Objectives: The objective of this study is to evaluate the efficacy and tolerability of racecadotril as a treatment of acute diarrhea in children. Methods: This double-blind, randomized controlled clinical trial was conducted in Dr. MR Khan Children Hospital & Institute of Child Health over 1 year (June 2017- May 2018). The study was approved by the ethical committee of the institute. The efficacy and tolerability of racecadotril (1.5 mg/kg) administered orally 3 times daily) as adjuvant therapy to oral rehydration or intravenous fluid were compared with those of placebo in 40 children aged 3 months to 60 months of children who had acute diarrhea. Results: During the first 72 hours of treatment, patients receiving racecadotril had a significantly lower stool output (grams per hour) than those receiving placebo. The mean (±SE) 72-hours stool output was 54.75± 12.92 g per kilogram in the racecadotril group and 152.50±37.64 g per kilogram in the placebo group (p<0.001). The number of purging is significantly reduced in the racecadotril group than the placebo group (11.95±2.41 Vs 14.85±1.95, p= 0.000) on third day of admission. The duration of hospital stay is significantly lower in the racecadotril group than the placebo group (73.30±23.44 vs. 177.30±25.8. p= 0.000) group. Racecadotril was well tolerated; only 3 patients taking racecadotril had adverse effects like vomiting and 2 patients had hypokalaemia and 3 patients in the placebo group developed vomiting and 1patient developed hypokalaemia which all are mild and transient. Conclusion: In young children with acute watery diarrhea, racecadotril is an effective and safe treatment along with rehydration therapy. DS (Child) H J 2020; 36(1) : 8-13

scholarly journals Pengaruh suplementasi zink (Zn) terhadap diare pada penderita umur 6-36 bulan yang dirawat di RSUD Dr. Soedarso Pontianak, Kalimantan Barat

2005 ◽  
Vol 1 (3) ◽  
pp. 113
Author(s):  
Jurianto Gambir ◽  
Madarina Julia ◽  
Muhammad Jufrrie
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Zinc Supplementation ◽  
Watery Diarrhea ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled ◽  
Acute Watery Diarrhea ◽  
Childhood Death

Background: Diarrhoea is one of the major causes of infants and childhood death in Indonesia. Malnutrition and zinc deficiency in diarrhoea may lead to impaired immunity.Objective: To assess the influence of zinc supplementation on the duration of diarrhoea and the frequency of watery stools in under-three-year-old childrenMethod: This was a double-blind randomized controlled clinical trial, with 31 children in the supplemented group and 33 children in the placebo group. All children had acute watery diarrhea and were given supplementation within 24 hours of admission. Daily supplementation of 20 mg zinc was given to the experimental group.Results: The supplemented group had a shorter hospitalization compared to the placebo. Beginning from the second day of supplementation, the frequency of watery stools in the supplemented group was significantly less than in the placebo group (p<0.001). While there was a significant decrease in the concentration of zinc in the serum of the placebo group, there was a slight increase in the supplemented group.Conclusion: Zinc supplementation can shorten hospitalization and reduce the frequency of watery stools in children with diarrhoea.

Clinical Trial of Glucose-Oral Rehydration Solution (ORS), Rice Dextrin-ORS, and Rice Flour-ORS for the Management of Children With Acute Diarrhea and Mild or Moderate Dehydration

PEDIATRICS ◽  
1995 ◽  
Vol 95 (2) ◽  
pp. 191-197
Author(s):  
Susana Molina ◽  
Carolina Vettorazzi ◽  
Janet M. Peerson ◽  
Noel W. Solomons ◽  
Kenneth H. Brown
Keyword(s):  
Clinical Trial ◽  
Treatment Group ◽  
Acute Diarrhea ◽  
Oral Rehydration Solution ◽  
Rice Flour ◽  
Watery Diarrhea ◽  
Hydration Status ◽  
Oral Rehydration ◽  
Acute Watery Diarrhea ◽  
Rehydration Solution

Objective. To assess the effects of glucose (G)-oral rehydration solution (ORS), rice dextrin (RD)-ORS, and rice flour (RF)-ORS on fluid intake, rapidity of rehydration, and stool output of children with acute diarrhea and mild or moderate dehydration. Methods. The study was a randomized, double-masked clinical trial. One hundred forty-six male infants, ages 3 to 36 months, were randomly assigned to one of three treatment groups. Clinical evaluations and fluid balances were conducted every 2 to 4 hours for 48 hours. Principal outcome variables were ORS consumption, recovery of hydration status, and fecal output. Results. The groups were similar at admission with regard to age, nutritional status, history of the current episode, and clinical status. There were no differences in ORS consumption by treatment group during any period of study. During the first 6-hour period, patients in group RF had less stool output (16 ± 14 g/kg/body weight) than those in group G (22 ± 20 g/kg) or RD (21 ± 19 g/kg; P &lt; .05). After 12 hours of hospitalization, there were no differences by treatment group. Recovery of hydration status, changes in serum sodium and potassium, and duration of diarrhea in the hospital were similar in all three groups. Conclusion. There was a 24% to 27% reduction in stool output during the first 6 hours of treatment among children who received RF-ORS compared with those who received G-ORS or RD-ORS, but this effect did not persist after the first 12 hours of therapy. Because this difference was of small magnitude and limited duration, it has minor clinical importance. Thus, we conclude that the three solutions had similar efficacy for children with acute, watery diarrhea and mild or moderate dehydration.

scholarly journals The benefit of co-trimoxazole treatment in the management of acute watery diarrhea caused by invasive bacterial infection

2007 ◽  
Vol 47 (3) ◽  
pp. 104
Author(s):  
Bobby Setiadi Dharmawan ◽  
Agus Firmansyah ◽  
Imral Chair
Keyword(s):  
Placebo Group ◽  
Bacterial Infection ◽  
Clinical Manifestations ◽  
World Health ◽  
Watery Diarrhea ◽  
Double Blind ◽  
Symptomatic Infection ◽  
Lactose Malabsorption ◽  
Acute Watery Diarrhea ◽  
Invasive Bacterial Infection

Background World Health Organization (WHO) states thatantimicrobials are reliably helpful only for children with bloodydiarrhea (probable shigellosis), suspected cholera with severedehydration, and symptomatic infection caused by Giardia lamblia.The benefit of antimicrobial treatment in management of acutewatery diarrhea caused by invasive bacterial infection is still debated.Objective To prove the benefit of co-trimoxazole treatment inthe management of acute watery diarrhea caused by invasivebacterial infection in patients age 2–24 months.Methods This was a randomized, double blind clinical trialinvolving infants and children aged 2–24 months with acutewatery diarrhea caused by invasive bacterial infection withoutco-morbidity or complications. Invasive bacterial infection wasdefined by fecal leukocytes greater than ten cells (+2) per highpower field on stool. Subjects were assigned to receive either co-trimoxazole or placebo. The duration and frequency of diarrheabetween two groups were compared.Result Of 70 patients (co-trimoxazole, n=35; placebo, n=35),42 (60%) were children aged 12–24 months, of whom 61% wereundernourished. Males were affected 1.2 times as much as females.The clinical manifestations were mild-moderate dehydration(64%), mucus in the stool (100%), fever (24%), vomiting (10%),fever with vomiting (56%) and lactose malabsorption (53%).Duration of diarrhea in placebo group (mean 117.0 [SD 28.1]hours) was not significantly different (P=0.43) compared to thatin co-trimoxazole group (mean 122.5 [SD 30.1] hours). Frequencyof diarrhea per day in placebo group (mean 5.23 [SD 1.48] times)was not significantly different either (P=0.37) compared to thatin co-trimoxazole group (mean 5.64 [SD 2.20] times).Conclusion It is concluded that co-trimoxazole therapy providesno benefit to patients with acute watery diarrhea caused byinvasive bacterial infection. This disorder seems to be self-limited.

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

scholarly journals The Effects of Propolis Extract Administration on HIV Patients Receiving ARV

2021 ◽  
Vol 13 (1) ◽  
pp. 75-83
Author(s):  
Erwin Astha Triyono ◽  
Sarah Firdausa ◽  
Heru Prasetyo ◽  
Joni Susanto ◽  
James Hutagalung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Cd4 Count ◽  
Controlled Clinical Trial ◽  
Human Immune System ◽  
Hiv Patients ◽  
Double Blind ◽  
Significant Difference

BACKGROUND: Human immunodeficiency virus (HIV) is an infectious disease that targets the human immune system by attacking cluster of differentiation (CD)4 cells. The use of propolis in HIV patients is expected to be safe and beneficial in terms of increasing endurance and immunity by its role in increasing CD4 level. This study aimed to analyze the influence of propolis supplementation in increasing the CD4 level in anti-retroviral (ARV)-treated HIV patients.METHODS: Double-blind randomized controlled clinical trial was conducted in 50 HIV patients who took regular ARV therapy. The subjects were divided into two groups, one group was treated with ARV and propolis, while another one was given ARV and placebo. The CD4 cell count was measured during pre-treatment, in the 3rd month, in the 6th month after treatment. The level of hemoglobin, leukocyte, and platelets were also measured. The SF-12 questionnaire was used to evaluate quality of life of the subject.RESULTS: Out of 50 subjects, 43 subjects completed the study, which were 19 subjects from the propolis group and 24 subjects from the placebo group. After 3-month of treatment, there was a statistically significant difference in the incrwase of CD 44 level in propolis group, while the increment was not significant in the placebo group. After 6-month treatment, the increase of CD4 level was occurred in both groups, propolis and placebo, however the increment was not statistically significant. The levels of hemoglobin, leukocyte, and platelets were not altered by the treatment and remained normal throughout the study. The quality of life was improved during the study; however, it was also not statistically significant. Mild adverse events occurred in 3 subjects which were relieved after the treatment stopped.CONCLUSION: Based on the result of this study, the administration of propolis on HIV patients receiving ARV bring significant difference in the increase of CD4 in propolis group from baseline to 3 month after the treatment. While in placebo group, this increment was not significant. At the end of study, CD4 count continued to rise up, however the increase was not statistically significant. There are no hemoglobin, leukocyte, platelets, and quality of life abnormalities. Therefore, it is necesary to do further research with a spesific CD4 count. However, it may be beneficial in relieving the clinical symptoms and quality of life of patient living with HIV.KEYWORDS: CD4, ARV, HIV, propolis

Role of Oral Zinc Supplementation in treatment of Acute Dehydrating Diarrhea in age 6 months to 5 years

2021 ◽  
Vol 15 (11) ◽  
pp. 3002-3003
Author(s):  
Bakht Buland Shah ◽  
Inam ul Khair
Keyword(s):  
Placebo Group ◽  
Zinc Supplementation ◽  
Oral Rehydration Salt ◽  
Course Of Disease ◽  
Oral Rehydration ◽  
Oral Supplementation ◽  
Recommended Treatment ◽  
Double Blinded ◽  
Volume Current

Background: Oral Rehydration Salt (ORS) is the standard recommended treatment for acute dehydrating diarrhea but it has very little role in decreasing stool frequency and volume. Current studies recommend oral supplementation of zinc as an adjunct to ORS in treating acute dehydrating diarrhea of children especially those who are at risk of zinc deficiency and malnutrition. Aim: To determine the effect of oral zinc supplementation on duration of acute diarrhea and intake of ORS in children between 6 months and 5 years of age. Settings: Tehsil Head Quarters Hospital, Besham District Shangla, Khyber Pakhtunkhwa from October 2019 to September 2020. Methodology: The study was double blinded Randomized Control Clinical Trial in children aged between 6 months to 5 years of age. A total of 90 children were included in the study. In addition to rehydration, 45 children were given oral zinc (20mg daily) while 45 children were given placebo. Results: All 45(100%) patients in zinc group and 39(86.6%) patients in placebo group recovered after 5 days of treatment. Zinc group had significantly reduced duration of diarrhea (68.3±9.4 vs. 99.8±15.2 hours) and consumed less ORS solution (2.3±0.8 vs. 3.4±1.1 liters) as compared to placebo group. Conclusion: It is concluded from this study that oral zinc supplementation in addition to ORS in treating acute dehydrating diarrhea of children has better effect on the clinical course of disease. Key words: Diarrhea, ORS, Zinc, Dehydration.

scholarly journals Effects of Lactobacillus plantarum and Lactobacillus paracasei on the Peripheral Immune Response in Children with Celiac Disease Autoimmunity: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1925 ◽  
Author(s):  
Åsa Håkansson ◽  
Carin Andrén Aronsson ◽  
Charlotte Brundin ◽  
Elin Oscarsson ◽  
Göran Molin ◽  
...  
Keyword(s):  
Immune Response ◽  
Celiac Disease ◽  
Placebo Group ◽  
Inflammatory Responses ◽  
Tissue Transglutaminase ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Th Cells ◽  
Double Blind Placebo ◽  
Peripheral Immune Response

Two Lactobacillus strains have proven anti-inflammatory properties by reducing pro-inflammatory responses to antigens. This randomized double-blind placebo-controlled trial tested the hypothesis that L. plantarum HEAL9 and L. paracasei 8700:2 suppress ongoing celiac disease autoimmunity in genetically at risk children on a gluten-containing diet in a longitudinally screening study for celiac disease. Seventy-eight children with celiac disease autoimmunity participated of whom 40 received 1010 CFU/day of L. plantarum HEAL9 and L. paracasei 8700:2 (probiotic group) and 38 children maltodextrin (placebo group) for six months. Blood samples were drawn at zero, three and six months and phenotyping of peripheral blood lymphocytes and IgA and IgG autoantibodies against tissue transglutaminase (tTG) were measured. In the placebo group, naïve CD45RA+ Th cells decreased (p = 0.002) whereas effector and memory CD45RO+ Th cells increased (p = 0.003). In contrast, populations of cells expressing CD4+CD25highCD45RO+CCR4+ increased in the placebo group (p = 0.001). Changes between the groups were observed for NK cells (p = 0.038) and NKT cells (p = 0.008). Median levels of IgA-tTG decreased more significantly over time in the probiotic (p = 0.013) than in the placebo (p = 0.043) group whereas the opposite was true for IgG-tTG (p = 0.062 respective p = 0.008). In conclusion, daily oral administration of L. plantarum HEAL9 and L. paracasei 8700:2 modulate the peripheral immune response in children with celiac disease autoimmunity.

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