“GanedenBC30 reduces GI and URTI symptoms in children: study - NutraIngredients-usa.com” plus 1 more

GanedenBC30 reduces GI and URTI symptoms in children: study - NutraIngredients-usa.com

Posted: 26 Sep 2019 07:34 AM PDT

The report points out that respiratory infections are the most common infections in children, with acute respiratory infections representing 30–40% of medical consultations and 20–30% of hospitalizations worldwide, citing the World Health Organization.

Acute gastrointestinal infections come in second as the most common infections in children. Furthermore, infectious diarrhea ranks eighth as the most common cause of morbidity worldwide, with 1.4 million deaths in 2015, and the second most common cause of morbidity in developing countries, with 57.2 million deaths. The most common symptoms of GITI include diarrhea, constipation, intestinal inflammation, and vomiting (WHO).

With these two types of infections in mind, researchers studied 80 healthy school-aged children in Mexico in a randomized, double-blind, placebo-controlled study. The children, ages 6-8, received a flavored water containing either GanedenBC30 (1 billion CFU ) or a placebo, daily for 12 weeks.

Key Findings

The research found that supplementation with GanedenBC30 significantly reduced flatulence and suggested a positive effect on stool consistency. It also found that the probiotic significantly decreased the incidence of URTI symptoms, such as nasal congestion, bloody nasal mucus, itchy nose and hoarseness, and the duration of hoarseness, headache, red eyes, and fatigue.

Don Cox, R&D Director for Kerry's ProActive Health Division, the makers of GanedenBC30, said "While there is already a large body of evidence for the digestive and immune health benefits of GanedenBC30, this research is particularly exciting because it is the first to focus on children, and shows the enormous potential of GanedenBC30 as a functional ingredient in products for kids."

The study data reported that GanedenBC30 may have the ability to modulate the immune response, based on beneficial effects on URTI and GI symptoms. Previous studies have shown that GanedenBC30 can reduce gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms, and improves pain and bloating in IBS sufferers.

GanedenBC30 is the trademarked brand name of the bacterial strain, Bacillus coagulans GBI-30, 6086. The probiotic ingredient is in many foods and beverages and aids digestive as well as immune health when taken daily.

According to the makers of the probiotic, it's a shelf-stable, science-backed probiotic strain that has been shown to provide digestive health, immune health and protein utilization benefits. The company says unlike most other probiotic strains, GanedenBC30 is a spore-former, making it highly stable and allowing it to remain viable throughout most manufacturing processes . They add that the spore safeguards the probiotic from heat, cold and pressure of manufacturing processes, allowing for stability during the product shelf life and protects the cells from the acid and bile they are exposed to during transit through the digestive system. Once it is safely inside the small intestine, they claim the probiotic germinates and colonizes to provide benefits.

"We are committed to driving forward probiotic innovation through science and helping meet the demand for high-quality ingredients, substantiated by high-quality research," continued Cox. "These latest findings support our ongoing efforts to provide an efficacious probiotic ingredient that can withstand harsh manufacturing processes and conditions in the body."

Source: Food Research International Volume 125, November 2019, doi: https://doi.org/10.1016/j.foodres.2019.108567 'Bacillus coagulans GBI-30, 6068 decreases upper respiratory and gastrointestinal tract symptoms in healthy Mexican scholar-aged children by modulating immune-related proteins' Anaya-Loyola, M.A. et al.

Rituxumab Gains First Pediatric Approval - Drug Topics

Posted: 30 Sep 2019 02:08 PM PDT

The FDA has approved the use of Genentech's rituximab (Rituxan) intravenous infusion, in combination with glucocorticoids, for the treatment of granulomatosis (GPA) with microscopic polyangiitis (MPA) in pediatric patients two years of age and older.

Rituxan is a CD20-directedcytolytic antibody also indicated for the treatment of non-hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, moderate to severe pemphigus vulgaris, and GPA with MPA in adult patients.

"Rituxan is now approved as the first and only medicine for pediatric patients living with GPA and MPA, two potentially life-threatening blood vessel disorders which are rare in children," said Sandra Horning, MD, chief medical officer and head of Global Product Development, in a statement.

The approval is based upon results of the Phase IIa, global, open-label, multi-center, single-arm study investigating the product's safety and efficacy. 25 patients with active GPA or MPA between the ages of six and 17 years of age were treated with four weekly infusions of rituximab or non-U.S.-licensed rituximab in combination with a tapering course of oral glucocorticoids. At the start of the study, 19 participating patients had GPA, while six had MPA.

Efficacy results were measured as an exploratory endpoint and assessed using the Pediatric Vasculitis Activity Score (PVAS). Fifty-six percent of patients achieved PVAS remissions by month six, 92% by month 12, and 100% by month 18.

Safety was consistent in type, nature, and severity with the known safety profiles of rituximab in adult patients with GPA, MPA, rheumatoid arthritis, and pemphigus vulgaris.

Rituximab comes with a boxed warning of potential fatal infusion-related reactions that occur within 24 hours of administration, usually in response to the first infusion; severe mucocutaneous reactions, some fatal; Hepatitis B virus reactivation, sometimes resulting in fulminant hepatitis, hepatic failure, and death; and progressive multifocal leukoencephalopathy resulting in death.

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Other warnings include tumor lysis syndrome, infections, cardiac adverse reactions, renal toxicity, bowel obstruction and perforation, and embryo-fetal toxicity. Live virus immunizations are not recommended prior to or during treatment with rituximab.

Adverse events reported across all indications include fever, lymphopenia, chills, infection, asthenia, infusion-related reactions, neutropenia, upper respiratory tract infection, nasopharyngitis, urinary tract infection, bronchitis, nausea, diarrhea, headache, muscle spasm, anemia, peripheral edema, and depression.

Full Prescribing Information

Severe Acute Respiratory Syndrome