Clinical Trials With Microbiome Profiling Kits

Parameters:

● The study included Indians in the age range of 42-65 years with hyperglycemia and hyperlipidemia

● Study subjects were divided into two groups: one received the BugSpeaks-based personalized diet and the other a regular diet for 3 months.

● On day 90, improvements were seen in the personalized diet group across various parameters including HbA1c, CRP, and blood pressure.

● The study demonstrates that gut microbiota-directed diet plans can supplement the anti-diabetic medication to enhance the overall condition of people with diabetes.

A recent study has been done by BugSpeaks, India’s first gut microbiome profiling kit that shows remarkable results for people with diabetes. The clinical trial included Indian adults in the age group 42-65, both male and female, with hyperglycemia (high blood sugar) and hyperlipidaemia (high cholesterol). Study subjects were divided into two groups: one received the BugSpeaks-based personalized diet and the other a regular diet for 3 months. The patients who were given a BugSpeaks-based personalized diet showed excellent results across various parameters when examined on day 90 of the study. Their HbA1c levels were brought down from 8.30 to 6.67, systolic blood pressure was reduced by 14 per cent, and CRP levels, a marker of inflammation, were decreased by 20 per cent. The study has been uploaded onto a preprint server MedRxiv and is yet to undergo peer review.

The study also found that the number of beneficial microorganisms like Phascolarctobacterium succinatutens, Bifidobacterium angulatum, and Levilactobacillus brevis, increased two-fold and a similar decrease was observed in non-beneficial species like Alistipes finegoldii and Sutterella faecalis. Maintaining the balance of gut microbiota is important as an imbalance, also known as dysbiosis, can cause or aggravate different diseases including but not limited to digestive issues such as inflammatory bowel syndrome, mental health issues like anxiety and depression, and menstrual problems.

Speaking on the promising results of the clinical trial, Dr Debojyoti Dhar, Co-Founder & Director (Business Development and Innovation), Leucine Rich Bio, and the lead author of the study says, “In this study, we have highlighted the positive effect of gut microbiota based personalized nutrition on hyperglycaemia, hypertension, and inflammation markers. This “proof of concept” clinical trial shows that BugSpeaks based nutritional modulation of the gut microbiota can impact health positively and can supplement medication for diseases like type 2 diabetes.”

He adds, “Gut microbiota modulation through nutrition can provide a new dimension in the precision or personalized healthcare paradigm and this study is a step towards that direction.”

The trial was conducted using BugSpeaks, a flagship technology of Leucine Rich Bio, India’s first microbiome-based company. BugSpeaks is a gut microbiome profiling test that provides nutritional recommendations based on the individual’s gut microbiota profile. With India being called the diabetes capital of the world housing more than 101 million people with diabetes, the results of this study are groundbreaking for the prevention and management of diabetes.