Clasado Prebiotic Real-World Evidence Study Suggests Positive Impact On IBS, Pain And Sleep

A real-world evidence (RWE) study using Clasado Biosciences’ Bimuno GOS ingredient has found positive impacts related to prebiotic intake and common gastrointestinal symptoms, chronic pain and sleep.

Conducted in collaboration with the Primary Care Society for Gastroenterology (PCSG) and published in the PCSG journal The Digest, the study reveals significant improvements in quality of life across gastrointestinal health, chronic pain and sleep for participants with diagnosed or self-diagnosed irritable bowel syndrome (IBS) and sleep disturbances, Clasado reports.

“RWE studies are extremely useful in understanding the effects and benefits of Bimuno GOS,” commented Clasado’s director of R&D Lucien Harthoorn. “Clinical trials are under controlled and ideal conditions, where RWE brings insight into how a product can support users in day-to-day use.”

“Bimuno GOS stands out as the most studied prebiotic ingredient of its kind, and this RWE study further strengthens that research,” Harthoorn added.

‘Marked Improvement’

Based on an internet-based questionnaire completed by 1,171 UK-based Bimuno adult users, the study aimed at determining the key motivations for taking the product and to assess their symptoms.

“Over one in three respondents had diagnosed or self-diagnosed IBS, a similar number suffered sleep disturbances and a quarter experienced chronic pain,” the researchers explained.

That a “relatively high percentage” reported use of Bimuno for chronic pain was an “unexpected observation” that warranted “further investigation into the benefits of prebiotics,” they added.  

Among individuals who were motivated to use Bimuno for GI problems, chronic pain and sleep, the study found a “marked self-reported improvement in quality of life.”

Before using Bimuno, 29% of participants reported the impact of their condition on quality of life as ‘significant’ – 5 on a 5-point scale where 1 = ‘no impact’ and 5 = ‘significant impact’ – and 67% reported a score of 4 or 5.

Following use of Bimuno, these numbers fell to one in five (19%) and almost one in two respectively (48%). The majority (59%) of these users rated the usefulness of Bimuno in improving their condition as 4 or 5 out of 5.

Limitations

However, the researchers noted numerous limitations of the study, which meant that “only limited and cautious inferences can be drawn” from the results and “they should be considered only as an adjunct to the existing controlled clinical trial data.”

For example, the study was driven entirely by participant responses, with no objective measures, the authors noted. The age and regional spread of the study population was not nationally representative and only internet-users could participate. “The use of an online questionnaire may also be confounded by recall bias,” they added.

The subjects had variable underlying GI symptoms and health conditions, which means that no conclusive associations between benefits and specific symptoms can be drawn, they warned, and 70% of respondents were using other products and medication in conjunction with Bimuno, either for the issues stated or for other unconnected reasons.

Furthermore, around two-thirds of respondents had made at least one lifestyle change – dietary change and increased exercise being the most significant.

“The use of the Bimuno database as a means of collecting real-world evidence is associated with some obvious limitations and should only be considered as an insight into the pattern of real-world use,” the authors concluded.

Further Study Warranted

Nevertheless, the RWE study represents a “helpful addition to understanding the positive impact prebiotics can have,” commented PCSG chair Marion Sloan. “Further investigation into the benefits of taking prebiotics for certain GI problems and sleep is surely warranted.”

“For health and nutrition formulators engaged in the development of gut health-supporting products, primarily targeting digestive health, this research will be of interest as it confirms Bimuno as a strong science-backed choice of prebiotic ingredient,” added Clasado’s Harthoorn.

Read Clasado CEO Per Rehné’s thoughts on what this year will bring for dietary supplement companies, and on the promise of prebiotics for health and wellness innovation, as part of HBW Insight’s Vision 2024 series.