Holigos® IBS beneficially modulates intestinal microbiota in IBS patients
Holigos® IBS has been shown in a randomized, placebo-controlled, double-blind study (n=60) to beneficially modulate the intestinal microbiota, in particular by increasing abundance of bifidobacteria, without increasing gastrointestinal symptoms as measured by GSRS-IBS (Trial NCT02875847)1. The trial included IBS patients of all subtypes (IBS-C, IBS-D and IBS-M). Further, randomized, placebo-controlled, double-blind studies in healthy children (n=75) and adults (n=100)2 have shown increases in bifidobacteria.
Holigos® IBS substantially improves clinical symptoms in all IBS subtypes
Holigos® IBS has been shown in a 3-month, open-label, multi-center study (n=300) to improve IBS symptoms in all IBS subtypes as measured by IBS-SSS from severe to mild (Trial NCT03550742).
Further patients experienced reduced pain severity and a decrease in the number of days with pain from 6 days to 2 days over a 10 day recall. Bloating severity was reduced by more than 60% and the number of abnormal bowel movement (constipation and diarrhea) halved. In addition, quality of life improved by 55% on domains such as energy and mood. The full impact on symptom improvement occurred by 4 weeks of intervention and was maintained throughout the 12-week intervention period.
Holigos® IBS is safe and well tolerated
In the clinical trials mentioned above, Holigos® IBS did not differ from placebo in safety and tolerance parameters or induce safety or tolerance concerns. Also, the number of adverse events (AEs) reported were similar for participants taking Holigos® IBS or placebo. All AEs were considered to be of mild or moderate severity. No serious adverse events attributed to Holigos® IBS have been reported. Also trial discontinuation rates were infrequent and similar between those taking Holigos® IBS and placebo.
1 Iribarren, C., et al, The Effects of Human Milk Oligosaccharides on Bifidobacteria and gastrointestinal symptoms in IBS: A parallel, Double Blind, Randomized, Placebo-controlled Trial, DDW2019. 2 Elison, E., et al., Oral supplementation of healthy adults with 2'-O-fucosyllactose and lacto-N-neotetraose is well tolerated and shifts the intestinal microbiota. Br J Nutr, 2016: p. 1-13.