Bovine Colostrum in the Treatment of Acute Diarrhea in Children: A Double-Blinded Randomized Controlled Trial.

OBJECTIVES: To evaluate the effect of bovine colostrum (BC) on the treatment of children with acute diarrhea attending the outpatient clinic. METHODS: This double-blind randomized controlled trial was conducted on 160 children with diarrhea; 80 cases were randomly treated with BC group and 80 cases randomly received placebo (placebo group). All cases were investigated for bacterial causes of diarrhea (Salmonella spp, Shigella spp, diarrheagenic E. coli (DEC), Campylobacter spp., and Vibrio cholerae) as well as for Rotavirus antigen in stool. RESULTS: After 48 h, the BC group had a significantly lower frequency of vomiting, diarrhea and Vesikari scoring compared with the placebo group (p = 0.000, p = 0.000, p = 0.000, respectively), whether it was due to Rotavirus or E. coli infection. CONCLUSIONS: BC is effective in the treatment of acute diarrhea and can be considered as adjuvant therapy in both viral and bacterial diarrhea to prevent diarrhea-related complications.

[A multicenter randomized parallel-controlled study on the efficacy and safety of er xie ting granules in children with acute diarrhea].

OBJECTIVE: To evaluate the efficacy and safety of ER XIE TING GRANULES in children with acute diarrhea. METHOD: A multicenter, randomized, open-label, parallel-controlled clinical trial was carried out in 15 hospitals during March 2011 to July 2012. A total of 1489 children with acute diarrhea were enrolled and divided randomly into two groups and treated with ER XIE TING GRANULES (treatment group) and smectite powder (control group). The therapeutic efficacy and adverse drug reactions were evaluated after three-day and seven-day therapy.Superiority or non-inferiority test was done for effectiveness of the treatment based on efficacy differ by more than 10% regarded as the superiority. RESULT: Totally 1458 children completed the study, in whom 726 children received ER XIE TING GRANULES and 732 received smectite powder. After three-day and seven-day therapy, cure rates and total efficacy rates of the treatment group were 44.2%, 94.1%, 88.8%, and 97.9% separately and higher than those of control group (39.3%, 88.4%, 83.9%, 97.4%) ( Z = 3.2, P < 0.01; Z = 2.46, P < 0.05). There were 520 children with rotavirus infection and in whom 266 cases received ER XIE TING GRANULES and 254 received smectite powder. For rotavirus enteritis, cure rates and total efficacy rates of the treatment group after three-day and seven-day therapy were 40.6%, 95.1%, 89.9%, and 98.9% separately and higher than those of control group (26.4%, 84.3%, 78.8%, and 96.8%) (Z = 4.807, P < 0.01;Z = 3.519, P < 0.01). The lower limits of the 95% confidence interval of difference of cure rate and total efficacy rates after three-day and seven-day therapy between two groups were less than 10%.No obvious drug related adverse reactions were found during the study. CONCLUSION: ER XIE TING GRANULES has the same effect for treatment of acute diarrhea and rotavirus enteritis in children.No obvious drug related adverse reactions were found.

Breastfeeding and the risk of rotavirus diarrhea in hospitalized infants in Uganda: a matched case control study.

BACKGROUND: Rotavirus is responsible for over 25 million outpatient visits, over 2 million hospitalizations and 527,000 deaths annually, worldwide. It is estimated that breastfeeding in accordance with the World Health Organization recommendations would save 1.45 million children's lives each year in the developing countries. The few studies that examined the effect of breastfeeding on rotavirus diarrhea produced conflicting results. This study aimed to determine the effect of breastfeeding on rotavirus diarrhea among admitted infants in Uganda. METHODS: The study was conducted in the Pediatrics medical emergency unit of a National Referral hospital during a peak incidence time for rotavirus from February to April 2008. It was an age matched case-control study with a ratio of 1:1. We consecutively enrolled infants presenting at the study site during this period whose caretakers consented to participate in the study. A minimum sample size of 90 pairs was adequate with power of 80% to detect a 30% decrease in breastfeeding rate among the cases assuming a breastfeeding rate of 80% in the controls. The infants with rotavirus positive results were the "cases". We used the commercial enzyme immunoassay kit (DAKO IDEIA™ rotavirus EIA detection kit) to diagnose the cases. The "controls" were admitted children with no diarrhea. We compared the cases and controls for antecedent breastfeeding patterns. RESULTS: Ninety-one matched case-control age-matched pairs with an age caliper of one month were included in the analysis. Breastfeeding was not protective against rotavirus diarrhea (OR 1.08: 95% CI 0.52 - 2.25; p = 0.8) in the conditional logistic model. CONCLUSIONS: Our study findings did not reveal breastfeeding as protective against rotavirus diarrhea in infants. This suggests searching for other complementary preventive methods such as rotavirus vaccination and zinc supplementation to reduce the problem of rotavirus diarrhea in infants irrespective of their feeding practices.

[Clinical observation on treatment of infantile rotavirus enteritis by umbilical application of lunxieting paste].

OBJECTIVE: To observe the clinical effect of umbilical application with Lunxieting Paste (LXT) for the treatment of infantile rotavirus enteritis (IRE). METHODS: One hundred and ninety infants with IRE were randomly assigned into three groups, 55 in Group A, 60 in Group B and 75 in Group C. All were treated with conventional therapy, mainly the dehydration and acidosis correcting, rehydration salt and antiviral therapy; but to patients in Groups B and C, an additional medication of Smecta 1.5 g, thrice a day. for infants below 1 year and 3 g, thrice a day. for those between 1-2 years old, by orally taken with 0.05 L of warm water and umbilical application with LXT (one dose per day, containing 6.0 g of crude drug) was given respectively. RESULTS: The total effective rate was 69.1% in Group A, 75% in Group B and 92% in Group C, respectively, showing significant difference (P<0.05) in comparing Group C with Groups A and B. Moreover, serum levels of TNF-alpha were decreased and IFN-gamma increased in Group C after treatment, all showed statistical significance as compared with those in the other two groups (P<0.05). No significant adverse reactions were observed in all patients. CONCLUSION: Umbilical application of LXT could effectively alleviate the diarrhea symptom in IRE patients, accelerate the negative inversion of rotavirus, and reduce the injury of intestinal membrane, showing a therapeutic efficacy more effective and quicker than that of conventional treatment with more convenience for use.

Australian Rotavirus Surveillance Program annual report, 2007/08.

The National Rotavirus Reference Centre together with collaborating laboratories Australia-wide conducts a laboratory based rotavirus surveillance program. This report describes the types of rotavirus strains responsible for the hospitalisation of children with acute gastroenteritis during the period 1 July 2007 to 30 June 2008, the first complete year of surveillance following introduction of rotavirus into the National Immunisation Program. Six hundred faecal samples from across Australia were examined using a combined approach of monoclonal antibody immunoassays and reverse transcription-polymerase chain reaction. Of the 419 confirmed as rotavirus positive, serotype G1 was the dominant serotype nationally, representing 52% of specimens, followed by serotype G2 (19.8%), serotype G9 (12.2%), and serotype G3 (11%). No serotype G4 strains were identified. All G1, G3 and G9 strains assayed for P genotype contained the P[8] genotype, while all G2 strains contained the P[4] genotype, except one G2 strain which possessed a P[8]. Uncommon rotavirus genotypes, G8 (n = 2) and P[9] (n = 2) were identified during this study period. There was no evidence of unexpected changes in serotype distribution during the first 12 months of rotavirus vaccine use in the National Immunisation Program.

Australian Rotavirus Surveillance Program: annual report, 2006-07.

The National Rotavirus Reference Centre, together with collaborating laboratories Australia-wide, conducts a laboratory based rotavirus surveillance program. This report describes the serotypes of rotavirus strains responsible for the hospitalisation of children with acute gastroenteritis during the period 1 July 2006 to 30 June 2007. One thousand and two faecal samples from across Australia were examined using a combined approach of monoclonal antibody immunoassays, reverse transcription-polymerase chain reaction and polyacrylamide gel analysis. Serotype G1 was the dominant serotype nationally, representing 36.7% of all strains, followed by serotype G9 (31.1%), and serotype G3 (23.3%). Serotype G2 represented less than 5% of strains, while no serotype G4 strains were identified. All G1, G3 and G9 strains assayed for P genotype contained the P[8] genotype, bar one G1 strain, which possessed a P[6]. Uncommon rotavirus genotypes, G8 (n = 1) and G12 (n = 2) were identified in children with acute gastroenteritis during this study period.

National Rotavirus Surveillance Program annual report, 2005-06.

The National Rotavirus Reference Centre together with collaborating laboratories Australia-wide has conducted rotavirus surveillance since June 1999. This report describes the serotypes of rotavirus strains responsible for the hospitalisation of children with acute gastroenteritis during the period 1 July 2005 to 30 June 2006. Eight hundred and forty-eight faecal samples from across Australia were examined using monoclonal antibody immunoassays, reverse transcription-polymerase chain reaction and polyacrylamide gel analysis. Serotype G1 was the dominant serotype nationally, representing 40.2 per cent of all strains, followed by serotype G4 (22.6%), serotype G9 (15.1%) and serotype G3 (14.7%). Genotype G12 strains were identified for the first time in Australia. As in previous years, there was substantial geographic variation in the prevalence of rotavirus serotypes.

In vitro anti-rotavirus activity of some medicinal plants used in Brazil against diarrhea.

Acute diarrhea, especially in children, is a very common disease with worldwide distribution and with a significant public health impact. Rotaviruses have been recognized as the major agents of diarrhea in infants and young children in developed as well as developing countries. In Brazil, diarrhea is one of the principal causes of death, mainly in the infant population. To fight diarrhea, traditional Brazilian medicine uses a great variety of plants. In this work, 12 medicinal plant species were screened for simian (SA-11) and human (HCR3) rotaviruses inhibition in vitro. At non-cytotoxic concentrations, the extracts from Artocarpus integrifolia L. (Moraceae) bark (480 microg/ml) and Spondias lutea L. (Anacardiaceae) leaves (160 microg/ml) had antiviral activity against both viruses. They showed inhibition of 99.2% and 97%, respectively, for human rotavirus, and 96.4% and 96.2% for simian rotavirus. The extracts from Myristica fragrans Houtt (Myristicaceae) seeds (160 microg/ml) and Spongias lutea bark (40 microg/ml) inhibited human rotavirus (90% and 82.2% inhibition, respectively), whereas the extracts from Anacardium occidentale L. (Anacardiaceae) leaves (4 microg/ml) and Psidium guajava L. (Myrtaceae) leaves (8 microg/ml) showed activity only against simian rotavirus (82.2% and 93.8% inhibition, respectively). Our results indicate that the extracts of Artocarpus integrifolia, Myristica fragrans and Spongias lutea can be useful in the treatment of human diarrhea if the etiologic agent is a rotavirus.

Effect of oral administration of tormentil root extract (Potentilla tormentilla) on rotavirus diarrhea in children: a randomized, double blind, controlled trial.

OBJECTIVES: To determine the effectiveness of tormentil root extract (TRE) for treatment of rotavirus diarrhea in children. BACKGROUND: Rotavirus, one of the most widely spread pathogens of acute, dehydrating diarrhea in children, is estimated to cause >800 000 annual deaths of young children in developing countries. Currently no rotavirus vaccine is available. Management involves rehydration therapy. Available antiperistaltic or antisecretory drugs to reduce the severity of diarrhea can cause serious side effects in children. METHODS: A randomized, double blinded, placebo-controlled trial was conducted at Children's Hospital for Infectious Diseases #3, St. Petersburg, Russia in 40 children ranging in age from 3 months to 7 years with rotavirus diarrhea. We constructed 2 groups for comparison: a treatment group that consisted of 20 children treated with tormentil root extract; and a control group of 20 children who received a placebo. All patients received 3 drops of tormentil root extract or placebo per year of life, three times daily until discontinuation of diarrhea, or a maximum of 5 days. An objective method was used to evaluate diarrhea, and physical examination was used to assess degree of dehydration in children. RESULTS: The duration of diarrhea in the tormentil root extract treatment group was 3 days, compared with 5 days in the control group (P < 0.0001). In the treatment group 8 of 20 (40%) children were diarrhea-free 48 h after admission to the hospital, compared with 1 of 20 (5%) in the control group (P < 0.0001). Subjects in the treatment group received smaller volumes of parenteral fluids than subjects in the control group. CONCLUSIONS: The administration of tormentil root extract in controlled doses shortened the duration of rotavirus diarrhea and decreased the requirement for rehydration solutions. Tormentil root extract appears to be an effective measure to treat rotavirus diarrhea in children.

Oral bacterial therapy promotes recovery from acute diarrhea in children.

Lactobacilli in the intestines play an important role in developing natural defenses against both intestinal bacterial and viral infections. So a prospective clinical study was carried out at Cathay General Hospital to determine the effect of Lactobacillus acidophilus and Bifidobacterium infantis on the course of acute diarrhea in hospitalized children. Altogether 100 children between 6 and 60 months of age were collected and randomly allocated into 2 groups. Study group (n = 50) was given Infloran Berna, which contains 10(9) viable Lactobacillus acidophilus and 10(9) Bifidobacterium infantis, one capsule tid for 4 days and control group (n = 50) received parenteral rehydration only without any medication. Only 20 stool cultures in study group had positive culture results for Lactobacillus or Bifidobacterium. All children were evaluated for the degree of dehydration before rehydration. The clinical course of diarrhea was followed during the treatment period. Features on admission were similar between the study group and control group in age, duration of diarrhea at home, serum sodium & potassium and dehydration degree. The duration of diarrhea was defined as the time until the last appearance of watery stool. There was no difference between the study group and control group in the frequency of diarrhea stools on the day before admission (p > 0.05). However, the frequency of diarrhea for study group improved on the first and second day of hospitalization with statistical difference (p < 0.01). The duration of diarrhea during hospitalization in study group also decreased (3.1 vs. 3.6 days, p < 0.01). Oral bacterial therapy is an effective adjuvant therapy in rotavirus positive and negative children with diarrhea and can safely be administered during an episode of acute diarrhea.

[Clinical study on treatment of infantile rotaviral enteritis with Psidium guajava L].

OBJECTIVE: To observe the clinical effect of olium Psidium guajava (PG) in treating infantile rotaviral enteritis. METHODS: Sixty-two patients of rotaviral enteritis were randomly divided into the treated group treated with PG and the control group treated with Gegen Qinlian decoction. The time for ceasing diarrhea, the content of Na+ in blood, the content of Na+ and glucose in stool, and the rate of negative conversion of human rotavirus (HRV) antigen were observed. RESULTS: The rate of recovery in 3 days of the treated group was 87.1%, significantly higher than that of the control group (58.1%, P < 0.05). The time of ceasing diarrhea of the treated group (25.1 +/- 9.5 hr) was significantly shorter than that of the control group (38.7 +/- 15.2 hr, P < 0.01). The content of Na+ and glucose in stool was reduced obviously in the treated group, while the reduction in the control group was insignificant, the treated group was superior to the control group significantly (P < 0.05). The rate of negative conversion of HRV in feces of the treated group was 87.1%, significantly better than that of the control (58.1%, P < 0.05). CONCLUSION: The treatment with PG has good curative effect on infantile rotaviral enteritis.

[Clinical and experimental study on treatment of infantile autumn diarrhea by retention enema with Qilian liquid].

OBJECTIVE: To find out the effective treatment for infantile autumn diarrhea (IAD). METHODS: Retention enema with Qilian Liquid (QLL) was applied to the patients of IAD with positive antigen of rotavirus in stool, and the clinical effect in the treated group was compared with that in the control group in aspects of negative conversion rate of rotavirus and change of immunoglobulin. Animal experimental study was also conducted. RESULTS: The disappearance time of principal symptoms, negative conversion rate of rotavirus and serum levels of IgA and IgG in the treated group were significantly higher than those in the control group (P < 0.01, P < 0.05). Experimental study showed that QLL not only has the the anti-viral effects to stop diarrhea, but also has effects in enhancing immune function and protecting intestinal mucous membrane. CONCLUSION: Retention enema with QLL is an effective therapy for the treatment of IAD.

Neonatal hypocalcaemia associated with rotavirus diarrhoea.

UNLABELLED: We observed an association between rotavirus diarrhoea and hypocalcaemia in several patients and therefore started a prospective evaluation with measurement of calcium levels in all patients with rotavirus infection during a period of 8 months. We report on 54 infants with rotavirus gastro-enteritis. Serum concentrations of sodium, potassium, and total and ionized calcium were measured on admission. If hypocalcaemia was detected, total and ionized calcium were measured every day until recovery. Calcium was supplemented as calcium gluconate which was added to milk. Out of 54 newborns with rotavirus gastro-enteritis, 20 developed hypocalcaemia. All these newborns had severe diarrhoea. Seven infants were admitted because of convulsions, but EEG and ultrasonographic examination of the brain revealed no abnormalities. Once the infants' clinical condition and the consistency and frequency of the stool had improved, calcium concentrations increased and remained within the reference range without supplementation. CONCLUSION: Rotavirus gastro-enteritis seems to be a cause of neonatal hypocalcaemia.

Successful treatment of rotavirus diarrhea in children with immunoglobulin from immunized bovine colostrum.

BACKGROUND: Oral ingestion of immunoglobulins in humans has been shown to be effective as prophylaxis against enteric infections. However, its therapeutic effect in children with infectious diarrhea has hitherto not been proven. We treated children with rotavirus diarrhea with immunoglobulins extracted from immunized bovine colostrum (IIBC) containing high titers of antibodies against four rotavirus serotypes. METHODS: In this double blind placebo-controlled trial, 80 children with rotavirus diarrhea were randomly assigned to receive orally either 10 g of IIBC (containing 3.6 g of antirotavirus antibodies) daily for 4 days or the same amount of a placebo preparation. The daily stool output (grams/kg/day), intake of oral rehydration solution (ml/kg/day), stool frequency (number of stools/day) and presence of rotavirus in stool were monitored for the 4 days during treatment. RESULTS: Children who received IIBC had significantly less daily and total stool output and stool frequency and required a smaller amount of oral rehydration solution than did children who received placebo (P < 0.05). Clearance of rotavirus from the stool was also earlier in the IIBC group compared with the placebo group (mean day, 1.5 vs. 2.9, P < 0.001). No adverse reactions from the colostrum treatment were observed. CONCLUSIONS: Treatment with antirotavirus immunoglobulin of bovine colostral origin is effective in the management of children with acute rotavirus diarrhea.

Hyperimmune cow colostrum reduces diarrhoea due to rotavirus: a double-blind, controlled clinical trial.

The therapeutic efficacy of hyperimmune bovine colostrum (HBC) from cows immunized with four serotypes of human rotavirus was evaluated in a double-blind, randomized trial in 75 boys, aged 6-24 months, infected with rotavirus diarrhoea. The treatment group received 100 ml of HBC three times a day for 3 consecutive days, while the controls received the same amount of bovine colostrum from significantly shorter duration of diarrhoea than the controls (median 56 versus 72 h (p<0.001); confidence interval of median difference (CI) 8-32 h). Total stool output (g/kg) between admission and cessation of diarrhoea was reduced by 29% in the HBC-treated group compared with controls (median 205 versus 290 g (p=0.04); CI = 1-154 g). In 50% of the children in the study group, diarrhoea stopped by 48 h, whereas 100% of the controls were still suffering from diarrhoea. No untoward effects were noted in either group. Colostrum from cows immunized with rotavirus antigen is clinically effective in reducing the duration and severity of childhood diarrhoea due to rotavirus.

[Efficacy of poria-polyporus anti-diarrhea oral liquor in treating infantile rotavirus diarrhea: a controlled study with smicta].

The efficacy of Poria-Polyporus Anti-diarrhea Mixture (PPAM) in infantile rotavirus diarrhea with Smicta was observed. In two groups of patients, altogether 60 patients were enrolled. The effective rate in the PPAM group and Smicta groups were 83.33% and 90.00% (P < 0.05) respectively. No statistically significance in respect of the duration of fever and diarrhea. Human rotavirus RNA in stool was detected by PAGE, which showed positive result in 13 patients of PPAM group and 19 in Smicta group. The duration of virus excretion in both group were 2-7 days, which was much shorter than 9-21 days of previous report.