Table 2.

Prospective randomized controlled trials of lactose in children with AP-FGIDs

Authors [Ref.], country (year)	Design	Results
Lebenthal et al. [20], USA (1981)	Children with RAP (n = 38: 21 LHBT positive/ 17 LHBT negative) 6-week baseline period followed by double-blind crossover challenges × 6 weeks (chocolate cow’s milk vs. chocolate soy milk)	10/21 with a positive LHBT versus 4/17 (p = 0.13) with a negative LHBT had worsening of pain with cow’s milk versus regular diet 7/21 with a positive LHBT versus 4/17 (p = 0.51) with a negative LHBT had worsening of pain with soy milk versus regular diet
Dearlove et al. [22], UK (1983)	Children with RAP (n = 21: 8 lactose intolerant and 13 lactose tolerant) 2-week baseline followed by 2-week lactose-free diet followed by double-blind crossover challenge × 2 weeks (tonic with vs. without lactose)	1/8 lactose-intolerant versus 4/13 (p = 0.34) lactose-tolerant improved with lactose-free diet 1/8 lactose-intolerant versus 2/13 (p = 1.0) lactose-tolerant worsened with the lactose tonic
Gremse et al. [21] USA (2003)	Children with RAP (n = 30) all with lactose malabsorption by LHBT 14-day double-blind crossover challenge (lactose-containing vs. lactose-hydrolyzed milk, 12 g/240 ml); subjects had been instructed to otherwise maintain a lactose-free diet throughout	Abdominal pain scores were significantly lower on the lactose hydrolyzed milk (p = 0.02); bloating, diarrhea, flatulence scores were lower but not statistically significantly different on the lactose-hydrolyzed milk

LHBT = Lactose hydrogen breath test.