IGH Naturals Receives Approval to Begin Clinical Trial Chemotherapy Patients

IGH Naturals Receives IRB Approval to Begin Clinical Trial on HuMOLYTE™ Impact on Hydration and Mucositis in Patients with Cancer Receiving Chemotherapy

IGH Naturals has received IRB approval to conduct a pivotal clinical study on the effectiveness of HuMOLYTE™, a medical food product, in alleviating the harsh side effects of chemotherapy. The study was approved by BRANY IRB (Biomedical Research Alliance of New York, LLC).

Chemotherapy, a cornerstone in the fight against cancer, is often accompanied by severe side effects, including oral ulcers, also known as stomatitis or mucositis, and gastrointestinal distress, such as nausea, vomiting, and diarrhea. These side effects can significantly affect a patient's nutrition and hydration, posing additional challenges during an already difficult time.

The IRB-approved study will evaluate the efficacy of pre-and during-chemotherapy hydration with HuMOLYTE™ in reducing the incidence of mouth sores and gastrointestinal symptoms. Currently, there are very few products that address the critical need for reducing the incidence and severity of mucositis from chemotherapy.

HuMOLYTE™is an electrolyte hydration mix with human milk oligosaccharide (or HMO) 2-fucosyllactose, one of the most abundant non-digestible sugars isolated first from human milk. The 2’-FL is now commercially available as a synthesized HMO and has a significant role in the improvement of gut health in adults and infants.

"We are thrilled to have received the IRB approval for this study, which underscores our commitment to advancing cancer care and improving patient outcomes," said Dr. Sourabh Kharait, MD, PhD, CEO of IGH Naturals. "Patients undergoing chemotherapy are often confused about how to improve their hydration, and the measures to take to reduce the incidence of dehydration, oral ulcers and other side effects of chemotherapy. Through this research, we aim to bring a tangible improvement to the quality of life for cancer patients by addressing some of the most debilitating side effects of chemotherapy".

The clinical trial is open to participation for all eligible patients in the United States. More information about this trial can be obtained by contacting the clinical coordinator at trial@humolyte.com or by phone at (877) 471-4233.

About IGH Naturals

IGH Naturals is a Nephrologist-founded startup dedicated to improving the health of individuals using scientifically proven nutrition. In 2019, the company commercialized a novel magnesium-rich electrolyte hydration mix, MAGNAK, that improves muscle performance in endurance athletes and is now adopted by many professional athletes. The company utilizes its expertise by designing nutritional products using Nutrient Co-transfer technology, a novel scientific method that utilizes the ability of one nutrient (electrolyte, protein, prebiotic) to enhance the function of other nutrients in the human body. All of the formulas that the company is introducing are backed by scientific rigor, clinical studies and are protected with intellectual property.