The study published on Vaccine showed that HOWARU® Restore II appears to lower the risk of AAD, CDAD, and gastrointestinal symptoms in a dose-dependent manner in adult in-patients.
A triple-blind, randomized placebo-controlled trial, conducted at the Shanghai Changhai Hospital, aimed to determine the dose-response effect of a 4 strain probiotic combination (HOWARU® Restore II) on the incidence of AAD and CDAD and the severity of gastrointestinal symptoms in adult in-patients requiring antibiotic therapy.
Patients (n = 503) were randomized among 3 study groups: HOWARU® Restore probiotic 1.70 × 1010 CFU (high-dose, n = 168), HOWARU® Restore probiotic 4.17 × 109 CFU (low-dose, n = 168), or placebo (n = 167). The primary endpoint of the study was the incidence of AAD. Secondary endpoints included incidence of CDAD, diarrhea duration, stools per day, bloody stools, fever, abdominal cramping and bloating.
Study products were administered daily up to 7 days after the final antibiotic dose. Results show that, a significant dose-response effect on AAD was observed with incidences of 12.5, 19.6, and 24.6% with high-dose, low-dose, and placebo, respectively (p = 0.02). CDAD was the same in both probiotic groups (1.8%) but different from the placebo group (4.8%; p = 0.04). Incidences of fever, abdominal pain and bloating were lower with increasing probiotic dose. The number of daily liquid stools and average duration of diarrhea decreased with higher probiotic dosage.