Clinical Studies:
More and more people understand the link between gut health and overall health and well-being. Gut health can be negatively influenced by the stresses of everyday life – poor diet, skipped meals and travel, as well as antibiotic and prescription drug use to name a few. For example, antibiotic associated diarrhea (AAD) is experienced by 1 in 5 antibiotic users or 180 million people annually. Studies have shown that one of the most effective and natural precautions consumers can take to overcome the negative effects of gut stresses, such as antibiotic therapy, is to supplement the diet with an efficacious dose of live and active probiotic bacteria. For patients who are experiencing general gastrointestinal discomfort caused by these daily stressors, doctors frequently recommend eating yogurt. However, not all yogurts contain probiotics. Furthermore, yogurts and most probiotic supplements deliver a far lower dose of probiotics than contained in HOWARU® Restore II.
Additionally, most of these products lack any clinical data supporting their ability to rapidly reestablish gut microflora after GI stress. The beneficial effect of HOWARU® Restore probiotics on the incidence of AAD and Clostridium difficile-associated diarrhea (CDAD) during and after antibiotic use has been confirmed in a large (N = 503), randomized, triple-blinded, placebo-controlled, dose-ranging study in healthy adult, inpatient volunteers requiring antibiotic therapy. In this study, the primary objective was to investigate the incidence of AAD at different doses of the HOWARU® Restore II probiotic compared with a placebo. The secondary objectives were to investigate the dose effect on the severity and duration of AAD and CDAD, the number of liquid stools per day, fever, bloody stools, bloating and abdominal pain. Subjects were stratified according to age (30–49 and 50–70 years), sex, and antibiotic treatment duration (3–8 and 9–14 days). HOWARU® Restore was administered from the start of antibiotic therapy and continued for 7 days after the cessation of antibiotic treatment.
Key study finding: HOWARU® Restore II lowered the incidence of AAD, CDAD and gastro intestinal symptoms in a dose-dependent manner in adult inpatients.
HOWARU® Restore has been shown to reduce the impact of AAD in patients undergoing antibiotic therapy. Clinical study patients experienced a significant reduction in each of the following:
• Number of episodes of AAD
• Duration of diarrhea and number of liquid stools
• Diarrhea-associated symptoms such as fever, bloating and abdominal pain.