A multicenter double-blind, placebo-controlled randomized trial to evaluate the safety and efficacy of bovine colostrum in the treatment of severe alcoholic hepatitis (SAH).

BACKGROUND: Severe alcoholic hepatitis (SAH) is associated with high mortality. Numerous studies and meta-analysis have reported that corticosteroids reduce the 28-day mortality in SAH, but not the 6-month mortality. Therefore, newer treatments for SAH need to be studied. A pilot study from our group had recently treated ten patients with SAH with bovine colostrum (BC) [20 g thrice in a day for 8 weeks] and prednisolone. This therapy improved the biological functions and 3-month mortality. However, as more and more data showed the failure of corticosteroids to improve the 3- and 6-month mortality, especially in patients with high mDF and MELD scores, we planned this trial to study the safety and efficacy of BC (without corticosteroids) in the treatment of SAH. METHOD: This is a multicenter, parallel, double-blind, randomized (1:1) placebo-controlled trial, which will enroll 174 patients with SAH from 5 academic centers in the India. Patients will receive freeze-dried BC or placebo by random 1:1 allocation for 4 weeks. The primary outcome measure is survival at 3 months. The secondary outcome measures are survival at 1 month, change in mDF and MELD scores, change in endotoxin and cytokines (alpha TNF, IL6, and IL8) levels, number of episodes of sepsis [pneumonia, spontaneous bacterial peritonitis (SBP), cellulitis, urinary tract infection (UTI)] from baseline to 4 weeks. DISCUSSION: This study will evaluate the safety and efficacy of bovine colostrum in improving the survival of patients with SAH. TRIAL REGISTRATION: ClinicalTrials.gov NCT02473341. Prospectively registered on June 16, 2015.

Celiac disease and intussusception - a rare but important association.

Most of the cases of intussusception in children are labeled as idiopathic and not usually investigated. Only rare cases of chronic or recurrent intussusception receive greater attention and further investigations. Celiac disease appears to be associated with modestly increased risk of intussusception, although most of these cases remain asymptomatic. Debate still continues as to whether all patients of intussusception should be screened for celiac disease. We present case of a 7 years old child who presented with recurrent intussusception, underwent laparotomy initially and was later diagnosed to have celiac disease.

Sorafenib induced hepatic encephalopathy.

A 60 year old male, known case of Hepatitis C related cirrhosis was diagnosed with exophytic Hepatocellular carcinoma (size 2.1 x 2.2 cm), Barcelona Clinic Liver Cancer Stage A, on routine surveillance. He refused liver Transplant and underwent laparoscopic segmental resection. Thereafter patient was started on Tablet Sorafenib 400mg twice daily to prevent recurrence of Hepatocellular carcinoma. On 18st post-operative day, patient presented with Hepatic encephalopathy. Routine investigations and MRI Brain were normal; Venous ammonia was high. Sorafenib was discontinued, and neurological symptoms resolved within 24 hours. The ammonia level decreased from 112 to 30 µmol/L. Hepatic encephalopathy recurred 14 days after Sorafenib reintroduction at a dose of 400 mg / day. It resolved within 24 hours of withdrawal of Sorafenib. Sorafenib induced recurrent acute overt Hepatic encephalopathy with biochemical corroboration is reported here.

Recurrent lung infection due to chronic peri-odontitis.

Association between chronic lung disease and peri-odontal infection has recently been reported. The microbiology of peri-odontal infection and lung infection is almost similar. The most direct means by which the oral infection might influence lung disease is by aspiration of dental plaque bacteria into the lower respiratory tract. In this case report we are presenting a patient who suffered recurrent lung infection. Intra-oral examination revealed the presence of chronic peri-odontitis, which was not treated before. On providing treatment for lung infection in addition to that for peri-odontal infection, there was no recurrence of lung infection.