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BACKGROUND The role of fecal microbiota transplantation (FMT) for Clostridium difficile infection (CDI) is not well-known. PURPOSE To assess the efficacy, comparative effectiveness, and harms of FMT for CDI. DATA SOURCES MEDLINE (1980 to January 2015), Cochrane Library, and ClinicalTrials.gov, followed by hand-searching references from systematic reviews and identified studies. STUDY SELECTION Any study of FMT to treat adult patients with CDI; case reports were only used to report harms. DATA EXTRACTION Data were extracted by 1 author and verified by another; 2 authors independently assessed risk of bias and strength of evidence. DATA SYNTHESIS Two randomized, controlled trials (RCTs); 28 case-series studies; and 5 case reports were included. Two RCTs and 21 case-series studies (516 patients receiving FMT) reported using FMT for patients with recurrent CDI. A high proportion of treated patients had symptom resolution; however, the role of previous antimicrobials is unclear. One RCT comparing FMT with 2 control groups (n = 43) reported resolution of symptoms in 81%, 31%, and 23% of the FMT, vancomycin, or vancomycin-plus-bowel lavage groups, respectively (P < 0.001 for both control groups vs. FMT). An RCT comparing FMT route (n = 20) reported no difference between groups (60% in the nasogastric tube group and 80% in the colonoscopy group; P = 0.63). Across all studies for recurrent CDI, symptom resolution was seen in 85% of cases. In 7 case-series studies of patients with refractory CDI, symptom resolution ranged from 0% to 100%. Among 7 patients treated with FMT for initial CDI, results were mixed. LIMITATION Most studies were uncontrolled case-series studies; only 2 RCTs were available for analysis. CONCLUSION Fecal microbiota transplantation may have a substantial effect with few short-term adverse events for recurrent CDI. Evidence is insufficient on FMT for refractory or initial CDI treatment and on whether effects vary by donor, preparation, or delivery method. PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs.

Lactose intolerance resulting in gastrointestinal symptoms is a common health concern. Diagnosis and management of this condition remain unclear.To assess the maximum tolerable dose of lactose and interventions for reducing symptoms of lactose intolerance among persons with lactose intolerance and malabsorption.Multiple electronic databases, including MEDLINE and the Cochrane Library, for trials published in English from 1967 through November 2009.Randomized, controlled trials of individuals with lactose intolerance or malabsorption.Three investigators independently reviewed articles, extracted data, and assessed study quality.36 unique randomized studies (26 on lactase- or lactose-hydrolyzed milk supplements, lactose-reduced milk, or tolerable doses of lactose; 7 on probiotics; 2 on incremental lactose administration for colonic adaptation; and 1 on another agent) met inclusion criteria. Moderate-quality evidence indicated that 12 to 15 g of lactose (approximately 1 cup of milk) is well tolerated by most adults. Evidence was insufficient that lactose-reduced solution or milk with a lactose content of 0 to 2 g, compared with greater than 12 g, is effective in reducing symptoms of lactose intolerance. Evidence for probiotics, colonic adaptation, and other agents was also insufficient.Most studies evaluated persons with lactose malabsorption rather than lactose intolerance. Variation in enrollment criteria, outcome reporting, and the composition and dosing of studied agents precluded pooling of results and limited interpretation.Most individuals with presumed lactose intolerance or malabsorption can tolerate 12 to 15 g of lactose. Additional studies are needed to determine the effectiveness of lactose intolerance treatment.

Chronic hepatitis B infection can lead to liver failure, hepatocellular carcinoma, and death.To evaluate the effectiveness of antiviral therapy for adults with chronic hepatitis B infection.Randomized, controlled trials (RCTs) of interferon (alpha2b and pegylated alpha2a), lamivudine, adefovir, entecavir, and telbivudine published from 1990 to 2008.Randomized, controlled clinical trials of adults with chronic hepatitis B published in English after 1989 that reported death; incidence of hepatocellular carcinoma or liver failure; prevalence and incidence of cirrhosis; presence or seroconversion of hepatitis B e antigen (HBeAg) or surface antigen (HBsAg), viral load of hepatitis B virus DNA; aspartate aminotransferase and alanine aminotransferase (ALT) levels; or fibrosis scores after therapy with interferon-alpha2b, pegylated interferon-alpha2a, lamivudine, adefovir, entecavir, and telbivudine.Data extracted with standard protocols to calculate risk difference for clinical outcomes, viral load, HBeAg and HBsAg, ALT, histologic scores, and adverse events.In 16 RCTs (4431 patients), drug treatment did not improve clinical outcomes of chronic hepatitis B infection, but the trials were underpowered. In 60 RCTs that examined intermediate outcomes, no single treatment improved all intermediate outcomes. Low-quality evidence suggested HBsAg clearance after interferon-alpha2b (2 RCTs; 211 patients). Moderate-quality evidence suggested ALT normalization at follow-up after treatment with adefovir (2 RCTs; 600 patients) and HBeAg loss with lamivudine (2 RCTs; 318 patients). With interferon-alpha2b, moderate-quality evidence suggested HBeAg loss (3 RCTs; 351 patients), seroconversion (2 RCTs; 304 patients), and ALT normalization (2 RCTs; 131 patients). Pegylated interferon-alpha2a versus lamivudine improved HBeAg seroconversion (1 RCT; 814 patients) and ALT normalization (2 RCTs; 905 patients) off treatment. Pegylated interferon-alpha2a combined with lamivudine versus lamivudine improved HBeAg loss (1 RCT; 543 patients) and ALT normalization (2 RCTs; 905 patients). Adverse events during antiretroviral therapy occurred in more than 50% of patients but were not associated with increased treatment discontinuation. However, most studies excluded patients with hepatic or renal insufficiency or other serious comorbid conditions.Marked heterogeneity in study samples, interventions, and measured outcomes preclude definitive conclusions.Evidence was insufficient to assess treatment effect on clinical outcomes or determine whether inconsistent improvements in selected intermediate measures are reliable surrogates. Future research is needed to provide evidence-based recommendations about optimal antiviral therapy in adults with chronic hepatitis B infection.