scholarly journals Bovine Lactoferrin in the Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Michal F. Wronowski ◽  
Maria Kotowska ◽  
Marcin Banasiuk ◽  
Artur Kotowski ◽  
Weronika Kuzmicka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Antibiotic Therapy ◽  
Bovine Lactoferrin ◽  
Double Blind ◽  
Intention To Treat ◽  
Intravenous Rehydration ◽  
Single Center Study ◽  
Antibiotic Associated Diarrhea ◽  
To Receive ◽  
Treat Analysis

Introduction: Antibiotic-associated diarrhea (AAD) is a common adverse reaction to antibiotic treatment affecting up to 21% of children. The aim of the study is to evaluate whether bovine lactoferrin (bLf) might be used for AAD prevention.Materials and Methods: In this prospective, randomized, double-blind, placebo-controlled, single-center study, we enrolled 156 children aged between 1 and 18 years, treated with antibiotic due to acute respiratory or urinary tract infection. We randomly allocated children 1:1 to receive 100 mg of bLf or a placebo twice a day orally for the whole period of antibiotic therapy. The primary outcome was the occurrence of antibiotic-associated diarrhea during and up to 2 weeks after antibiotic therapy. The secondary endpoint was intravenous rehydration or antibiotic withdrawal due to diarrhea. We performed intention-to-treat analysis.Results: We included 150 patients in intention-to-treat analysis. AAD occurred in 16 of 75 (21.3%) patients in bLf group and in 7 of 75 (9.3%) individuals in placebo group [OR = 2.6, (95% CI: 1.01–6.84), p = 0.04]. Relative risk was 2.29 (95% CI: 0.89–5.88). The need for intravenous rehydration occurred in one patient in the placebo group (p = 0.3). We observed no adverse effects in neither of the groups.Discussion: The trial indicated that bLf is not effective in AAD prevention. The risk for AAD was higher in bovine lactoferrin group as compared with placebo. We registered the study protocol on ClinicalTrials.gov (NCT02626104).

scholarly journals Effect of a Fermented Milk CombiningLactobacillus AcidophilusCL1285 andLactobacillus Caseiin the Prevention of Antibiotic-Associated Diarrhea: A Randomized, Double-Blind, Placebo-Controlled Trial

2007 ◽  
Vol 21 (11) ◽  
pp. 732-736 ◽  
Author(s):  
Mélanie Beausoleil ◽  
Nadia Fortier ◽  
Stéphanie Guénette ◽  
Amélie L’Ecuyer ◽  
Michel Savoie ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Randomized Study ◽  
Fermented Milk ◽  
Daily Basis ◽  
Hospitalized Patients ◽  
Double Blind ◽  
Antibiotic Associated Diarrhea ◽  
Potential Measure ◽  
To Receive

BACKGROUND: Antibiotic-associated diarrhea is an important problem in hospitalized patients. The use of probiotics is gaining interest in the scientific community as a potential measure to prevent this complication. The main objective of the present study was to assess the efficacy and safety of a fermented milk combiningLactobacillus acidophilusandLactobacillus caseithat is widely available in Canada, in the prevention of antibiotic-associated diarrhea.METHODS: In this double-blind, randomized study, hospitalized patients were randomly assigned to receive either a lactobacilli-fermented milk or a placebo on a daily basis.RESULTS: Among 89 randomized patients, antibiotic-associated diarrhea occurred in seven of 44 patients (15.9%) in the lactobacilli group and in 16 of 45 patients (35.6%) in the placebo group (OR 0.34, 95% CI 0.125 to 0.944; P=0.05). The median hospitalization duration was eight days in the lactobacilli group, compared with 10 days in the placebo group (P=0.09). Overall, the lactobacilli-fermented milk was well tolerated.CONCLUSION: The daily administration of a lactobacilli-fermented milk was safe and effective in the prevention of antibiotic-associated diarrhea in hospitalized patients.

Amphetamine Withdrawal: II. A Placebo-Controlled, Randomised, Double-Blind Study of Amineptine Treatment

1999 ◽  
Vol 33 (1) ◽  
pp. 94-98 ◽  
Author(s):  
Manit Srisurapanont ◽  
Ngamwong Jarusuraisin ◽  
Jaroon Jittiwutikan
Keyword(s):  
Placebo Group ◽  
Therapeutic Effects ◽  
Double Blind Study ◽  
Double Blind ◽  
Intention To Treat ◽  
Parallel Group ◽  
Amphetamine Withdrawal ◽  
The Mean ◽  
Group 2 ◽  
Treat Analysis

Objective: The aim of this study was to examine the benefits of amineptine, a dopamine agonist antidepressant, in treating amphetamine withdrawal. Method: Inpatients with amphetamine withdrawal were recruited to participate in this placebo-controlled, randomised, double-blind, parallel group, 2-week comparison of amineptine and placebo treatments. The treatment effects were evaluated by means of the self-administered Amphetamine Withdrawal Questionnaire (AWQ) and the interviewer-administered Clinical Global Impression (CGI) scale. An intention-to-treat analysis was applied to evaluate the therapeutic effects at the end of week 1 and week 2. Results: Twenty-two patients took part in each treatment group. The week-1 and week-2 intention-to-treat analyses showed that the mean AWQ reversed vegetative scores (combined scores of decreased energy, increased appetite and craving for sleep items) of the amineptine group were significantly lower than those of the placebo group. The general condition of the amineptine group assessed by CGI also significantly improved at the end of week 2. Although the discontinuation rate due to dissatisfaction with treatment of amineptine group (1/21) was much lower than that of placebo group (6/22), those rates were not significantly different (p = 0.09). Conclusions: Amineptine is specifically effective for treating a major component of amphetamine withdrawal: a reversed vegetative syndrome. Although more than 2 weeks of amineptine treatment may contribute further benefits, both risks and benefits should be taken into account in doing so.

scholarly journals Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

2021 ◽  
Author(s):  
Juan Manuel Figueroa ◽  
Monica Lombardo ◽  
Ariel Dogliotti ◽  
Luis Flynn ◽  
Robert P. Giugliano ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Hospital Personnel ◽  
Culture Methods ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Efficacy ◽  
To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

Pirenzepine in Non-Ulcer Dyspepsia: A Double-Blind Multicentre Trial

1990 ◽  
Vol 18 (1) ◽  
pp. 16-20 ◽  
Author(s):  
P.M. Smith ◽  
A.H. Troughton ◽  
F. Gleeson ◽  
J. Walters ◽  
C.F. McCarthy
Keyword(s):  
Abdominal Pain ◽  
Placebo Group ◽  
Adverse Effects ◽  
Multicentre Study ◽  
Multicentre Trial ◽  
Nausea And Vomiting ◽  
Double Blind ◽  
Non Ulcer Dyspepsia ◽  
Upper Abdominal ◽  
To Receive

In a double-blind multicentre study to compare pirenzepine with placebo in non-ulcer dyspepsia, 71 patients were randomized to receive 50 mg pirenzepine or placebo given orally twice daily for 4 weeks. The trial was not completed by five patients in the pirenzepine group and six in the placebo group. There were no significant differences between the groups in respect to changes in total symptoms (upper abdominal pain, nausea and vomiting, early satiety and postprandial bloating, eructation and pyrosis) scores and outcome, although 27/35 (77%) patients receiving pirenzepine were cured or improved compared with 22/36 (61%) receiving the placebo. Adverse effects were reported by 13 (37%) patients treated with pirenzepine and by six (17%) treated with placebo, seven withdrawing due to adverse effects.

Ampicillin plus Mecillinam vs. Cefotaxime/Cefadroxil Treatment of Patients with Severe Pneumonia or Pyelonephritis: a Double-Blind Multicentre Study Evaluated by Intention-to-Treat Analysis

1995 ◽  
Vol 27 (5) ◽  
pp. 463-468 ◽  
Author(s):  
Stig Cronberg ◽  
Staffan Banke ◽  
Anne-Marie Bruno ◽  
Mikael Carlsson ◽  
Henrik Elmrud ◽  
...  
Keyword(s):  
Multicentre Study ◽  
Severe Pneumonia ◽  
Double Blind ◽  
Intention To Treat ◽  
Treat Analysis

Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9007-9007 ◽  
Author(s):  
S. Lee ◽  
S. Lee ◽  
Y. Chun ◽  
M. Kim ◽  
H. Chang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chemotherapy Regimen ◽  
Controlled Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Difference ◽  
Hand Foot Syndrome ◽  
Version 2.0 ◽  
The Mean ◽  
To Receive

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.

Treatment of neuroleptic-induced akathisia with the 5-HT2 antagonist mianserin

1999 ◽  
Vol 174 (3) ◽  
pp. 238-242 ◽  
Author(s):  
Michael Poyurovsky ◽  
Marina Shardorodsky ◽  
Camil Fuchs ◽  
Michael Schneidman ◽  
Abraham Weizman
Keyword(s):  
Placebo Group ◽  
Low Dose ◽  
Rating Scales ◽  
Therapeutic Option ◽  
Response To Treatment ◽  
Double Blind ◽  
Log Odds ◽  
Double Blind Design ◽  
To Receive ◽  
Barnes Akathisia Scale

BackgroundSerotonin (5-HT): dopamine imbalance may underlie neuroleptic-induced akathisia.AimTo evaluate the efficacy of the 5-HT2 antagonist, mianserin in neuroleptic-induced akathisia.MethodsThirty neuroleptic-treated patients with schizophrenia were randomly allocated in a double-blind design to receive either mianserin (15 mg/day) or placebo for five days. Patients were assessed at baseline and on Days 3 and 5 by the Barnes Akathisia Scale (BARS), as well as by other relevant clinical rating scales.ResultsCompared with the placebo group, the mianserin-treated patients showed a significant reduction in all four BARS subscales by Day 5, with mean reductions in the BARS global score of 9.9% and 52.2%, respectively (P=0.006). Response to treatment (a reduction of at least two points on the BARS global subscale), was noted in six patients (40%) in the mianserin group and only one patient (9.1%) in the placebo group (P=0.04, log odds ratio 2.23).ConclusionsMianserin at a low dose may be a promising therapeutic option for patients with acute neuroleptic-induced akathisia.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals Efficacy of Matricaria chamomilla L. in Infantile Colic: A Double Blind, Placebo Controlled Randomized Trial

2020 ◽  
pp. 1-11
Author(s):  
Fatemeh Mohamadi Sorme ◽  
Malihe Tabarra ◽  
Hosein Alimadady ◽  
Roja Rahimi ◽  
Mahdi Sepidarkish ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Infantile Colic ◽  
Matricaria Chamomilla ◽  
Double Blind ◽  
Serious Adverse Event ◽  
Double Blind Placebo ◽  
Common Problems ◽  
To Receive ◽  
Delivery Type

Objective: Infantile colic is one of the most common problems in neonatal and early infancy, the prevalence of which has been reported as 10-20%. The present clinical trial was conducted to investigate whether topical use of chamomile oil reduces crying and fussing in breastfed colicky infants. Methods: A total of 102 breastfed colicky infants were divided into two groups to receive topical chamomile or placebo oil 6 times a day for 7 days. Both groups also received 5 mg of Simethicone syrup 4 times a day. Parents reported on crying and fussing duration, exertion times and side effects using a questionnaire. Results: 90 babies could complete the trial including 47 patients in chamomile group and 43 patients in the placebo group. Babies in both groups were the same in terms of gestational age, birth weight, birth order, gender, delivery type, crying and fussing on the day before the treatment. At the end of the study, crying and fussing was found to be lower in chamomile group than the placebo group (p <0.001). Also, 39 and 27 patients responded to the treatment in chamomile and placebo groups respectively. The effect of chamomile oil on crying (p<0.01) and fussing (p< 0.001) was significant. No serious adverse event was reported. Conclusion: Results revealed that chamomile oil reduced symptoms in breastfed colicky infants compared to the infants in the placebo group. This suggests that topical use of chamomile oil may be effective in the treatment of colic.

scholarly journals Safety and immunogenicity of anti-SARS CoV-2 conjugate vaccine SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults: Phase IIb Clinical Trial

2022 ◽  
Author(s):  
Maria Eugenia-Toledo-Romani ◽  
Mayra Garcia-Carmenate ◽  
Leslyhana Verdecia-Sanchez ◽  
Suzel Perez-Rodriguez ◽  
Meybis Rodriguez-Gonzalez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Neutralizing Antibodies ◽  
Seroconversion Rate ◽  
Serious Adverse Events ◽  
Double Blind ◽  
The Third ◽  
Functional Antibodies ◽  
Dose Trial ◽  
To Receive

Background: We report results of immunogenicity, safety and reactogenicity of SOBERANA 02 in a two-dose or three-dose heterologous scheme in adults in a phase IIb clinical trial. Method: This phase IIb trial was designed as parallel, multicentre, adaptive, double blind, randomized and placebo-controlled. Subjects (N=810) aged 19-80 years were randomized to receive two doses of the recombinant SARS CoV-2 receptor binding domain (RBD) conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredient of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD IgG concentration. Secondary outcomes were safety, reactogenicity and neutralizing antibodies. Results: Seroconversion rate in vaccinees was respectively 76.3 and 96.8% after two or three doses, compared with 7.3% in placebo group. Anti-RBD IgG increased significantly after first and second dose of SOBERANA 02 respect to placebo group; and the third dose with SOBERANA Plus boosts the response compared to the second dose. Neutralizing IgG antibodies were detected against D614G and VOCs α, β and δ. Specific and functional antibodies were detected until 7-8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%); with only one serious AE consistent with vaccination. Local pain was the most frequent AE. Conclusions: Two doses of SOBERANA 02 were well tolerated, safe an immunogenic in adults aged 19-80 years old. The heterologous combination with a third dose of SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000347

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