Probiotics reduce symptoms of antibiotic use in a hospital setting: A randomized dose response study.¹

Study aim

To determine the dose-response effect of HOWARU® Restore formulation (Lactobacillus acidophilus NCFM®; Lactobacillus paracasei Lpc-37™; Bifidobacterium lactis Bi-07™; Bifidobacterium lactis Bl-04®) on the incidence of antibiotic associated diarrhea (AAD) and C. difficile associated diarrhea (CDAD) and severity of gastrointestinal (GI) symptoms in adults receiving antibiotic therapy.

Study design

Triple-blind, randomized, placebo-controlled

Study method

503 patients randomized to 3 treatment groups

• Placebo
• Low dose (4.17 billion CFU)
• High dose (17 billion CFU)

Study results

• The incidence of AAD in the high-dose HOWARU® Restore group was approximately half that of subjects in the placebo group (P=0.005)
• Subjects taking the low-dose HOWARU® Restore treatment experienced a lower incidence of AAD compared to placebo group, but the results were not statistically significant (P=0.08)

• HOWARU® Restore at both the low dose and high dose was shown to significantly reduce the duration of diarrhea by approximately 2 to 3 days compared to placebo (P<0.001)

HOWARU® Restore demonstrated an impact on undesirable GI symptoms during antibiotic therapy compared to placebo with:

• A significant reduction of abdominal pain for both groups (high dose: P<0.001; low dose: P=0.001)
• A significant reduction of bloating for the high group (P=0.01) with a significant linear dose-response trend (P=0.008)
• A significant reduction of fever in the high-dose group (P=0.02) with a trend toward fewer cases of fever in the low-dose group (P=0.09)

• Subjects taking the high dose of HOWARU® Restore had a significantly reduced incidence of CDAD (P=0.02)

Probiotics to minimize the disruption of faecal microbiotia in healthy subjects undergoing antibiotic therapy.²

Study aim

To determine if HOWARU® Restore formulation (Lactobacillus acidophilus NCFM®; Lactobacillus paracasei Lpc-37™; Bifidobacterium lactis Bi-07™; Bifidobacterium lactis Bl-04®; Bifidobacterium bifidum Bb-02™) could minimize antibiotic-induced disruption of fecal microbiota and facilitate its return to the baseline in healthy volunteers.

Study design

Randomized, placebo controlled

Study method

51 subjects randomized to 2 treatment groups:

• Placebo
• HOWARU® Restore (41 billion CFU/day)
• Subjects also received amoxicillin/ clavulanic acid (875 mg twice per day)

Subjects completed a diary recording stool frequency, gastrointestinal symptoms, and overall well-being throughout the protocol.

Study results

• Subjects in the HOWARU® Restore group experienced a rapid re-establishment of bifidobacterial levels while placebo shows no improvement 2 weeks after cessation of gut stress (P=0.03).

Bibliography