B 221, a medical food containing antisecretory factor reduces child diarrhoea: a placebo controlled trial

Area of Science:

• Pediatrics
• Gastroenterology
• Nutritional Science

Background:

• Diarrhea is a common and serious condition in young children.
• Effective treatments for acute and prolonged diarrhea are crucial for child health.
• Medical foods offer a novel approach to managing pediatric gastrointestinal issues.

Purpose of the Study:

• To evaluate the efficacy of B221 (Salovum), a medical food containing antisecretory factor (AF), in treating acute and prolonged diarrhea in children.
• To compare the outcomes of B221 treatment with placebo in pediatric patients.

Main Methods:

• A randomized controlled trial involving 240 children aged 6-24 months with either acute (<7 days) or prolonged (>=7 days) diarrhea.
• Participants received either 2 g of B221 or placebo every 5 hours for 3 days, mixed with oral rehydration salt solution.

Main Results:

• B221 significantly reduced stool frequency in acute diarrhea (p=0.0054) and normalized stool consistency more rapidly (p=0.053).
• Successful recovery within 3 days was higher in the B221 group (82.8%) compared to placebo (54.4%) for acute diarrhea.
• In prolonged diarrhea, B221 led to earlier normalization of stool consistency (p=0.008) with a higher success rate (90.9%) versus placebo (63.2%).

Conclusions:

• B221 (Salovum) is an effective medical food for improving outcomes in children with acute and prolonged diarrhea.
• The findings suggest B221 can be used to manage diarrhea caused by various undefined pathogens in pediatric populations.
• B221 demonstrates significant therapeutic potential in pediatric gastroenterology.