Miguel Campos

Impact of lactoferrin supplementation on growth and prevalence of Giardia colonization in children.

We conducted a randomized, double-blind, placebo-controlled trial comparing supplementation with bovine lactoferrin versus placebo for the prevention of diarrhea in children. Comparison of overall diarrhea incidence and prevalence rates found no significant difference between the 2 groups. However, there was a lower prevalence of colonization with Giardia species and better growth among children in the lactoferrin group.

Fecal screening tests in the approach to acute infectious diarrhea: a scientific overview.

OBJECTIVE To evaluate the value of fecal leukocytes, fecal occult blood, fecal lactoferrin and combination of fecal leukocytes with clinical data in the workup of patients with inflammatory diarrhea. DATA IDENTIFICATION A systematic literature search in all languages using MEDLINE (1970 to 1994), reference lists of articles primarily retrieved and of review articles and correspondence with experts in the field. STUDY SELECTION The search identified 2603 references, 81 of which were deemed relevant on the basis of prespecified selection criteria. Of these 25 contained sufficient data for further analysis and thus were finally included. DATA EXTRACTION All data from the selected articles were extracted by one observer whereas the second reviewer checked these data for accuracy. True positive rates and false positive rates were calculated from each 2 x 2 table. RESULTS OF DATA ANALYSIS The study summarizes the diagnostic accuracy of the signaled tests as predictors of inflammatory diarrhea as defined by stool culture (the reference test). Plots of true positive rates against false positive rates demonstrated widely scattered points, indicating heterogeneity. A summary receiver operating characteristic curve was fitted to the data with the use of logistic transforms and weighted least squares linear regression. Of the 25 studies analyzed 38 data points were used to construct summary receiver operating characteristic curves for index tests. CONCLUSIONS Fecal lactoferrin was the most accurate index test. Fecal leukocytes showed the lowest performance as assessed by the area under the curve. Occult blood and combination of fecal leukocytes with clinical data yielded intermediate curves. A limited number of studies (fecal lactoferrin, and fecal leukocytes with clinical data) and methodologic flaws identified in the assessed studies must be solved in future primary studies to improve the usefulness of the metaanalytic approach used here.

Efficacy of Sodium Stibogluconate Alone and in Combination with Allopurinol for Treatment of Mucocutaneous Leishmaniasis

A randomized, open, controlled clinical trial was designed to evaluate the efficacy, tolerance, and safety of sodium stibogluconate plus allopurinol and sodium stibogluconate alone as treatment of patients with mucocutaneous leishmaniasis. In phase 1 of the study, all 22 patients with severe disease had improvement of their lesions, but only two had clinical cure (both of these patients received sodium stibogluconate alone). In phase 2, which included 59 patients with moderate disease, the cure rate among sodium stibogluconate recipients was 75% (21 of 28) compared with 63.6% (14 of 22) among the sodium stibogluconate plus allopurinol recipients. The rates of clinical adverse events were similar among both groups. Thrombocytopenia was more frequent in the sodium stibogluconate plus allopurinol recipients, but the difference was not statistically significant. Eight patients (two sodium stibogluconate recipients and six sodium stibogluconate plus allopurinol recipients) withdrew from the study because of severe thrombocytopenia. In this study, the addition of allopurinol to sodium stibogluconate provided no clinical benefit as treatment of mucocutaneous leishmaniasis.

Screening and surgical intervention results from cataract-free-zone projects in Campinas, Brazil and Chimbote, Peru

Two cataract-free-zone projects, one in Brazil and the other in Peru, were designed to provide surgery to all those who need and want it within a defined geographic area. In-home visual acuity screening was accepted by three-fourths of the enumerated population aged 50 years or more. Those with reduced bilateral visual acuity were referred to a community health post for ophthalmic examination. Among those diagnosed as bilaterally blind (≤20/200), comprising 5% of the screened population, two-thirds were thought to be blind from cataract. Because of other ocular pathology and general health conditions, surgery was not indicated for 30–50%. Two-thirds of those recommended for out-patient surgery accepted. Motivational efforts to convince the refusers were uniformly unsuccessful. The average age of those accepting and those refusing surgery was in the mid-seventies. Those already aphakic were 7–8 years younger. Post-operative acuity was ≥20/50 for only one-half of those operated. A significant number of cases had previously undetected macular degeneration and other causes of decreased vision. These projects have given increased attention to cataract blindness and the need for further operational research to develop effective methods for its control using outpatient surgery.

Randomized double-blind controlled trial of bovine lactoferrin for prevention of diarrhea in children

OBJECTIVE To determine the effect of bovine lactoferrin (bLF) on prevention of diarrhea in children. STUDY DESIGN We conducted a community-based randomized double-blind placebo controlled trial comparing supplementation with bLF vs placebo. Previously weaned children were enrolled at 12-18 months and followed for 6 months with daily home visits for data collection and supplement administration. Anthropometric measures were done monthly. RESULTS Five hundred fifty-five children were randomized: 277 to bLF and 278 to placebo; 65 dropped out; 147 894 doses were administered (92% compliance). Overall there were 91 446 child-days of observation and 1235 diarrhea episodes lasting 6219 days. The main pathogens isolated during diarrheal episodes were norovirus (35.0%), enteropathogenic E coli (11.4%), Campylobacter (10.6%), enteroaggregative E coli (8.4%), enterotoxigenic E coli (6.9%), and Shigella (6.6%). The diarrhea incidence was not different between groups: 5.4 vs 5.2 episodes/child/year for bLF and placebo, respectively (P = .375). However, the diarrhea longitudinal prevalence was lower in the bLF group vs placebo (6.6% vs 7.0%, P = .017), as well as the median duration of episodes (4.8 vs 5.3 days, P = .046), proportion of episodes with moderate or severe dehydration (1.0% vs 2.6%, P = .045), and liquid stools load (95.0 vs 98.6) liquid stools/child/year, P < .001). There were no adverse events related to the intervention. CONCLUSIONS Although there was no decrease in diarrhea incidence, longitudinal prevalence and severity were decreased with LF.

SYBR Green–based quantitation of human T-lymphotropic virus type 1 proviral load in Peruvian patients with neurological disease and asymptomatic carriers: Influence of clinical status, sex, and familial relatedness

To evaluate the human T-lymphotropic virus type 1 (HTLV-1) proviral DNA load in patients with HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP) and asymptomatic HTLV-1 carriers, a SYBR Green-based real-time quantitative polymerase chain reaction (qPCR) assay was developed. HTLV-1 proviral DNA in peripheral blood mononuclear cells (PBMCs) was quantified using primers targeting the pX region and the HTLV-1 copy number normalized to the amount of ERV-3 (Endogenous Retrovirus 3) cellular DNA. Thirty-three asymptomatic HTLV-1 carriers (ACs) and 39 patients with HAM/TSP were enrolled. Some participants were relatives of HAM/TSP cases (16 ACs and 7 patients with HAM/TSP). On multiple linear regression analysis, the authors found a significant association between clinical status and HTLV-1 proviral load (P < .01), but only among women. ACs showed a median proviral load of 561 copies per 104 PBMCs (interquartile range: 251–1623). In HAM/TSP patients, the median proviral load was 1783 (1385–2914). ACs related to HAM/TSP patients presented a relatively high proviral load (median 1152); however, the association between relatedness to a HAM/TSP patient and proviral load was not significant (P = .1). In HAM/TSP patients, no association was found between proviral load and disease duration, progression or severity. The fact that the effect of HAM/TSP upon the HTLV-1 proviral load differed between sexes and the finding of a high proviral load among asymptomatic relatives of HAM/TSP patients suggest that not yet identified genetic or environmental factors influence the pathogenesis of HTLV-1 infection.

A diagnostic accuracy study of Xpert®MTB/RIF in HIV-positive patients with high clinical suspicion of pulmonary tuberculosis in Lima, Peru.

Background Diagnosis of pulmonary tuberculosis (TB) among human immunodeficiency virus (HIV) patients remains complex and demands easy to perform and accurate tests. Xpert®MTB/RIF (MTB/RIF) is a molecular TB diagnostic test which is rapid and convenient; the test requires minimal human resources and reports results within two hours. The majority of performance studies of MTB/RIF have been performed in high HIV burden settings, thus TB diagnostic studies among HIV patients in low HIV prevalence settings such as Peru are still needed. Methodology/Principal Findings From April 2010 to May 2011, HIV-positive patients with high clinical suspicion of TB were enrolled from two tertiary hospitals in Lima, Peru. Detection of TB by MTB/RIF was compared to a composite reference standard Löwenstein-Jensen (LJ) and liquid culture. Detection of rifampicin resistance was compared to the LJ proportion method. We included 131 patients, the median CD4 cell count was 154.5 cells/mm3 and 45 (34.4%) had TB. For TB detection among HIV patients, sensitivity of MTB/RIF was 97.8% (95% CI 88.4–99.6) (44/45); specificity was 97.7% (95% CI 91.9–99.4) (84/86); the positive predictive value was 95.7% (95% CI 85.5–98.8) (44/46); and the negative predictive value, 98.8% (95% CI 93.6–99.8) (84/85). MTB/RIF detected 13/14 smear-negative TB cases, outperforming smear microscopy [97.8% (44/45) vs. 68.9% (31/45); p = 0.0002]. For rifampicin resistance detection, sensitivity of MTB/RIF was 100% (95% CI 61.0–100.0) (6/6); specificity was 91.0% (95% CI 76.4–96.9) (30/33); the positive predictive value was 66.7% (95% CI 35.4–87.9) (6/9); and the negative predictive value was 100% (95% CI 88.7 –100.0) (30/30). Conclusions/Significance In HIV patients in our population with a high clinical suspicion of TB, MTB/RIF performed well for TB diagnosis and outperformed smear microscopy.

Randomized controlled trial of lactoferrin for prevention of sepsis in peruvian neonates less than 2500 g.

Background: Lactoferrin (LF) is a broad-spectrum antimicrobial and immunomodulatory milk glycoprotein. Objective: To determine the effect of bovine LF on the prevention of the first episode of late-onset sepsis in Peruvian infants. Methods: We conducted a pilot randomized placebo-controlled double blind study in infants with a birth weight (BW) less than 2500g in 3 Neonatal Units in Lima. Patients were randomized to receive bovine LF 200mg/kg/d or placebo for 4 weeks. Results: One hundred and ninety neonates with a BW of 1591 ± 408 g and a gestational age of 32.1 ± 2.6 weeks were enrolled. Overall, 33 clinically defined first late-onset sepsis events occurred. The cumulative sepsis incidence in the LF group was 12/95 (12.6%) versus 21/95 (22.1%) in the placebo group, and 20% (8/40) versus 37.5% (15/40) for infants less than or equal to 1500 g. The hazard ratio of LF, after adjustment by BW, was 0.507 (95% CI: 0.249–1.034). There were 4 episodes of culture-proven sepsis in the LF group versus 4 in the placebo group. Considering that children did not received the intervention until the start of oral or tube feeding, we ran a secondary exploratory analysis using time since the start of the treatment; in this model, LF achieved significance. There were no serious adverse events attributable to the intervention. Conclusions: Overall sepsis occurred less frequently in the LF group than in the control group. Although the primary outcome did not reach statistical significance, the confidence interval is suggestive of an effect that justifies a larger trial.

Clinical characteristics and risk factors for Vibrio cholerae infection in children

Surveillance was conducted during February and March 1991 in the pediatric emergency department of Cayetano Heredia Hospital, Lima, Peru, to contrast the characteristics of children with epidemic cholera with those of children with noncholera-associated diarrhea. Among 626 patients 14 years of age or younger, Vibrio cholerae O1 was isolated from stool specimens of 310 patients (49%), more commonly from children older than 24 months of age (66%; p < 0.0001) than from younger children. Cholera was clinically characterized by a more sudden onset; watery diarrhea; and associated abdominal pain, muscle cramps, and vomiting, which led to more severe dehydration and hospitalization more often than in noncholera cases. Only one patient with cholera died, for a case-fatality rate of 3.2 deaths per 1000 persons. Nonpotable water and uncooked foods were identified as probable vehicles for V. cholerae. The frequency of diarrhea among relatives of patients with cholera suggested intrafamily transmission. This study of epidemic cholera describes the clinical features and the risk factors for acquisition of the infection, and points out the low case-fatality rate with prompt and appropriate treatment.

Double-blind randomized placebo-controlled study of Bixa orellana in patients with lower urinary tract symptoms associated to benign prostatic hyperplasia.

OBJECTIVE To determine the efficacy of Bixa Orellana (BO) in patients with benign prostatic hyperplasia (BPH) presenting moderate lower urinary tract symptoms (LUTS). MATERIALS AND METHODS It is a prospective double-blind randomized placebo-controlled study. One thousand four hundred and seventy eight patients presenting moderate LUTS associated to BPH were interviewed, from whom we selected 136 to fulfill the criteria of inclusion and exclusion. Assignation was performed at random in blocks of four to receive B0 at a dose of 250 mg 3 times a day or placebo (Pbo) for 12 months, 68 patients were assigned to each group. From the patients in the study we obtained data of demographic, epidemiologic, symptom score, uroflowmetry and post void residual urine variables. RESULTS Basically both groups were compared clinically, demographically and biochemically. Throughout the study variations of symptom score, mean delta symptom score during each visit and the final average delta were similar for both groups (BO - 0.79 +/- 1.87 and Pbo - 1.07 +/- 1.49) (p = 0.33). Similarly variations of Qmax mean, Qmax average delta and final average delta were similar (BO 0.44 +/- 1.07 and Pbo 0.47 +/- 1.32) (p = 0.88). Variations of post void residual urine mean, post void residual urine average delta in each visit and the final average delta were similar for both groups (BO 4.24 +/- 11.69 and Pbo 9.01 +/- 18.66) (p = 0.07). No differences were found in the answers of clinically significant improvement assessed with relative risk and risk differences, even though the proportion of adverse effects was similar for both groups. CONCLUSION Patients with BPH that present moderate LUTS did not show any benefit receiving BO when compared to placebo.