Abstract: A single RCT met the inclusion criteria. Our 2018 search update identified no additional trials. The included trial evaluated BIG-IV for the treatment of infant botulism and included 59 treatment participants and 63 control participants. The control group received a control immune globulin that did not have an effect on botulinum toxin. Participants were followed during the length of their hospitalization to measure the outcomes of interest. There was some violation of intention-to-treat principles, and possibly some between-treatment group imbalances among participants admitted to the intensive care unit and mechanically ventilated, but otherwise the risk of bias was low. There were no deaths in either group, making any treatment effect on mortality inestimable. There was a benefit in the treatment group on mean duration of hospitalization (BIG-IV: 2.60 weeks, 95% confidence interval (CI) 1.95 to 3.25; control: 5.70 weeks, 95% CI 4.40 to 7.00; mean difference (MD) -3.10 weeks, 95% CI -4.52 to -1.68; moderate-certainty evidence); mechanical ventilation (BIG-IV: 1.80 weeks, 95% CI 1.20 to 2.40; control: 4.40 weeks, 95% CI 3.00 to 5.80; MD -2.60 weeks, 95% CI -4.06 to -1.14; low-certainty evidence); and tube or parenteral feeding (BIG-IV: 3.60 weeks, 95% CI 1.70 to 5.50; control: 10.00 weeks, 95% CI 6.85 to 13.15; MD -6.40 weeks, 95% CI -10.00 to -2.80; moderate-certainty evidence), but not on proportion of participants with adverse events or complications (BIG-IV: 63.08%; control: 68.75%; risk ratio 0.92, 95% CI 0.72 to 1.18; absolute risk reduction 0.06, 95% CI 0.22 to -0.11; moderate-certainty evidence). We found low- and moderate-certainty evidence supporting the use of BIG-IV in infant intestinal botulism. A single RCT demonstrated that BIG-IV probably decreases the duration of hospitalization; may decrease the duration of mechanical ventilation; and probably decreases the duration of tube or parenteral feeding. Adverse events were probably no more frequent with immune globulin than with placebo. Our search did not reveal any evidence examining the use of other medical treatments including serum trivalent botulism antitoxin.

Plain-language summary: Our searches of the medical literature revealed one relevant study, which was in infant botulism. The treatment was a single dose of a medicine made from human immune proteins (human-derived botulinum immune globulin intravenous, or BIG-IV). Fifty-nine infants received BIG-IV, and 63 infants received a placebo (inactive treatment). Each study participant was followed up for the duration of their hospitalization. This study was sponsored by the California Department of Health Services. There were no deaths in either group in the trial. Infants treated with BIG-IV spent, on average, about three weeks less time in hospital (i.e. 3.1 weeks versus 5.7 weeks) than infants who received the inactive treatment, and spent about three weeks less on a ventilator (1.8 weeks versus 4.4 weeks). The average duration of tube feeding in the BIG-IV group was more than six weeks less than in the placebo group (i.e. 3.6 versus 10 weeks). The risk of harmful effects of the treatment was probably no greater with BIG-IV than with the inactive treatment. The evidence was mostly of moderate certainty (low certainty for time spent on a ventilator). The review shows that BIG-IV probably shortens hospitalization; may shorten time spent on a ventilator; and probably reduces the duration of tube feeding compared to placebo. On the other hand, we found no evidence for or against botulism antitoxin or other treatments for botulism. The evidence is up-to-date to January 2018, when we updated the searches and found no new trials.