VSL#3 improves symptoms in children with irritable bowel syndrome: a multicenter, randomized, placebo-controlled, double-blind, crossover study.

BACKGROUND AND OBJECTIVES: : Irritable bowel syndrome (IBS) is a common problem in pediatrics, for which no safe and effective treatment is available. Probiotics have shown some promising results in adult studies, but no positive study has been published on pediatric age. We aimed at investigating the efficacy of VSL#3 in a population of children and teenagers affected by IBS, in a randomized, double-blind, placebo-controlled, crossover study conducted in 7 pediatric gastroenterology divisions. PATIENTS AND METHODS: : Children 4 to 18 years of age, meeting eligibility criteria, were enrolled. The patients were assessed by a questionnaire for a 2-week baseline period. They were then randomized to receive either VSL#3 or a placebo for 6 weeks, with controls every 2 weeks. At the end, after a "wash-out" period of 2 weeks, each patient was switched to the other group and followed for a further 6 weeks. RESULTS: : A total of 59 children completed the study. Although placebo was effective in some of the parameters and in as many as half of the patients, VSL#3 was significantly superior to it (P < 0.05) in the primary endpoint, the subjective assessment of relief of symptoms; as well as in 3 of 4 secondary endpoints: abdominal pain/discomfort (P < 0.05), abdominal bloating/gassiness (P < 0.05), and family assessment of life disruption (P < 0.01). No significant difference was found (P = 0.06) in the stool pattern. No untoward adverse effect was recorded in any of the patients. CONCLUSIONS: : VSL#3 is safe and more effective than placebo in ameliorating symptoms and improving the quality of life in children affected by IBS.

Hepatitis C in childhood.

The prevalence of hepatitis C virus (HCV) infection is relatively low in childhood. Blood transfusion has been the principal route of acquisition in children but vertical transmission is gradually occupying primacy in the developed world. The risk of vertical transmission increases with higher maternal viraemia and human immuno-deficiency virus (HIV) co-infection but current international guidelines do not suggest avoidance of vaginal delivery and breastfeeding to minimise the risk of vertical transmission. The diagnosis of perinatal transmission is different from that in older child or adult and detection of HCV-RNA is essential. Although the natural history of HCV infection in children is not well characterised, almost 50-80% will progress to chronic hepatitis among vertically infected and blood transfusion acquired hepatitis C cases. Children have a lower viral load, lower ALT values and milder histological derangement as compared to adults with chronic hepatitis C cases. Experience of treatment of chronic hepatitis C in children is limited and still evolving. Few patients achieve spontaneous remission and progression to a more severe liver disease might occur in adult life. Here, the natural history, diagnosis and management of HCV infection in children are discussed with special emphasis on features which are different from adults.

Immunonutrition.

Nutrition and immunology are interrelated. Several nutrients like arginine, glutamine, omega-3-fatty acids and nucleotides enhance cellular immunity, modulate tumor cell metabolism and improve clinical outcome in stress situations. Glutamine supplementation has been shown to decrease incidence of sepsis and to reduce length of hospital stay in bone marrow transplant patients, low birth weight infants, surgical and multiple trauma patients. Studies with arginine have shown a reduction in infectious complications and lower mortality, however a better understanding of the biology of arginine is needed. Omega-3-fatty acid supplimentation as in fish oil stimulates the immune system. The beneficial effects of immunonutrition in surgical patients has been demonstrated in several studies. It significantly reduces infectious complications and length of hospital stay. In critically ill patients immunonutrition may decrease infectious complications but it is not associated with a mortality advantage. Pediatric experience is limited, but the future is promising.

Liver transplantation in the developing world.

Liver transplantation is an accepted therapy for acute and chronic liver failure. Advances in preoperative and postoperative management and surgical techniques have extended the indications and improved results. Most international centres report one year actual survival rates of between 58-90% and 5-8 years survival of 75-80%. These developments, however, have been limited largely to the West. While the need for liver transplantation is well recognised in the developing world, liver transplantation has only recently been performed successfully in India. This article examines the challenges of liver transplantation in the developing world.

Helicobacter pylori in children.

Helicobacter pylori (Hp) infection is one of the most frequently encountered bacterial infections worldwide. Although strong epidemiological association exists between Hp infection and duodenal and gastric ulcers and gastric cancer in adults, the clinical spectrum of Hp infection in children is yet to be established. The increasing use of endoscopy as a diagnostic modality in gastroduodenal diseases in children has raised some questions regarding the role of Hp in causing symptoms in children and need for eradication therapy. Despite a variety of protocols, the standard therapy of Hp in children is still undecided. This article discusses the epidemiological and clinical spectrum of Hp infection in children and includes a review of various diagnostic modalities and treatment protocols for this infection.

Associated infections in persistent diarrhoea--another perspective.

Seventy-eight children diagnosed as cases of persistent diarrhoea (PD) from 1 month to 5 years of age (mean age 8.92 months) hospitalized during a 2-year study period were screened for the presence of non-gastrointestinal infections. Clinical screening suggested acute respiratory infection (ARI) in 30 per cent cases, urinary tract infection (UTI) in 19 per cent and acute suppurative otitis media (ASOM) in 10 per cent of cases. Investigations revealed pneumonia on chest X-ray (39 per cent), positive urine culture (32 per cent), leucocytosis (31 per cent) and positive blood culture (22 per cent). Seven cases (9 per cent) of pneumonia and 10 cases (13 per cent) diagnosed to have UTI were not identified on clinical screening and could be detected only after investigations. E. coli was the commonest organism isolated from urine culture (23 per cent) and blood culture (14 per cent); 54 per cent of cases had one or the other associated infection and 28 per cent were suffering from more than one infection. Bacterial pathogens were more frequently isolated from blood in children < 6 months (P < 0.01), with vomiting (P < 0.001), and severe malnutrition (P < 0.05); from urine in association with fever (P < 0.001), duration of diarrhoea > 4 weeks (P < 0.05), and vomiting (P < 0.001). Pneumonia was detected on chest radiograph more frequently in children with severe malnutrition (P < 0.001). Sixty eight per cent of cases were successfully treated with dietary management and appropriate treatment of associated infections and 18 per cent of cases died. Mortality was highest in association with sever oral thrush, severe malnutrition, septicaemia, and ARI. Our results suggest that majority of cases of PD are associated with one or the other non-gastrointestinal infections particularly UTI and ARI which may be missed on clinical examination unless efforts are made to investigate these children. Early detection and appropriate management of these infections can considerably modify hospital course and outcome.

Lea's Shield: a phase I postcoital study of a new contraceptive barrier device.

Lea's Shield is a new vaginal barrier contraceptive that may offer advantages over existing methods. It is made of silicone which is resistant to petroleum-based lubricants, does not absorb odors, and does not cause allergic reactions in users with latex sensitivity. It has an anterior loop for ease of insertion and removal and a one-way flutter valve. Its novel design has sufficient volume to fill the posterior fornix, which helps keep it in place and prevent sperm from entering the cervical os. This study evaluated with a standard postcoital test (PCT) the ability of the Lea's Shield used with spermicide or non-spermicidal lubricant to prevent sperm from entering midcycle cervical mucus. Ten sterilized women underwent four PCT cycles: one cycle in which no contraceptive barrier was used (a baseline cycle) and 3 cycles in which one of the following was used: Lea's Shield with spermicide, or with non-spermicidal lubricant, or the contraceptive diaphragm used with spermicide. All volunteers demonstrated more than 5 progressively motile sperm per high power field in the cervical mucus after intercourse in the baseline cycle. No motile sperm were found in the cervical mucus in any cycle in which Lea's Shield or the diaphragm was used with spermicide. No motile sperm were found in cervical mucus in 9 of 10 cycles in which Lea's Shield was used without spermicide. Only two progressively motile sperm were present in the cervical mucus of one volunteer who used the shield with non-spermicidal lubricant.(ABSTRACT TRUNCATED AT 250 WORDS)

PIP: The results of a Phase I postcoital study of Lea's Shield, a new vaginal barrier contraceptive, suggest that this device is as effective as the vaginal diaphragm, even when used without spermicide. Evaluated was the ability of the Lea's Shield to prevent sperm from entering midcycle cervical mucus. Ten sterilized women underwent a baseline cycle followed by three additional cycles under one of the following conditions: Lea's Shield with spermicide, Lea's Shield with a nonspermicidal lubricant, or standard vaginal diaphragm with spermicide. In the baseline cycle, all subjects demonstrated more than five progressively motile sperm per high power field in the cervical mucus after intercourse. No sperm were detected in the post-intercourse cervical mucus in either the women who used the standard diaphragm with spermicide or those using the Lea's Shield with spermicide. One volunteer who used the Lea's Shield without spermicide had two progressively motile sperm in the cervical mucus; however, this involved a small size device that is no longer manufactured and was considered unlikely to result in pregnancy. There were no side effects reported by Lea's Shield users. Advantages of this new device include its silicone composition (more resistant to heat and deterioration, less absorbent of odors, and less likely to cause allergic reactions than latex), anterior loop for ease of insertion and removal, one-way flutter valve, and lack of pressure on the urethra.

Initial and steady-state pharmacokinetics of a vaginally administered formulation of progesterone.

OBJECTIVE: The pharmacokinetics of a 100 mg vaginal progesterone suppository was evaluated on days 1 and 7 and a 200 mg suppository on day 14. All the volunteers were given oral 17 beta-estradiol during the study. STUDY DESIGN: Ten postmenopausal women volunteered for this study. Progesterone was given as a vaginal suppository. Peripheral venous samples were obtained at appropriate intervals and analyzed for 17 beta-estradiol and progesterone levels. Area under the curve for progesterone was assessed by the trapezoidal method. Statistical analysis was performed by a one-way analysis of variance. RESULTS: Serum 17 beta-estradiol levels ranged from 22 to 182 pg/ml. Maximal serum progesterone levels ranged from 5.7 to 20.9 ng/ml, with the mean maximal levels 13.97, 16.09, and 12.68 ng/ml (not significantly different) and a mean area under the curve of 168.13, 207.64 and 227.71 ng/ml per hour on days 1, 7, and 14 (not statistically different). CONCLUSIONS: These data indicate that vaginal absorption of progesterone is efficient. The lack of difference in the area under the curve for both doses suggests that the vaginal mucosa or the total surface area of the vagina may limit the absorption of progesterone from the vagina.