Enterosgel randomised controlled trial for acute diarrhoea in adults BMJ Open Gastroenterology 2019 - Arasaradnam Pandya Howell significant reduction in diarrhoea duration

2019: BMJ Open Gastroenterology: Acute Diarrhoea

BMJ Open Gastroenterology · 2019

Enterosgel® for the Treatment of Adults with Acute Diarrhoea in a Primary Care Setting: A Randomised Controlled Trial

Prof. Ramesh Arasaradnam  ·  Dr Preeti Pandya  ·  Dr Carol Howell  ·  BMJ Open Gastroenterology  ·  2019

Full citation

Enterosgel (polymethylsiloxane polyhydrate) for the treatment of adults with acute diarrhoea in a primary care setting: a randomised controlled trial.

Arasaradnam R, Pandya P, Howell C et al. BMJ Open Gastroenterology 2019.

105 adults enrolled in the randomised controlled trial
8 days maximum treatment duration with Enterosgel plus standard care
Significant reduction in duration of acute diarrhoea vs standard care alone

Study design

How the trial was conducted

This was a randomised controlled trial conducted in a primary care setting, enrolling 105 adult subjects with patient-reported acute diarrhoea. Participants were randomised to receive either Enterosgel® in addition to standard care, or standard care alone.

Trial design at a glance

Setting

Primary care — reflecting real-world clinical practice for acute diarrhoea management.

Treatment arm

Enterosgel® up to six times daily for up to 8 days, plus standard care (oral rehydration solution).

Control arm

Standard care alone (oral rehydration solution).

Enrolment

105 adult subjects with patient-reported acute diarrhoea.


Results

What the trial found

Enterosgel® treatment was associated with a significant reduction in the duration of diarrhoea in adults with patient-reported acute diarrhoea, compared with standard care alone. The findings demonstrate that adding Enterosgel® to standard oral rehydration therapy meaningfully shortens the course of acute diarrhoea in adults in a primary care setting.


Conclusion

Why these findings matter

These findings support the role of Enterosgel® in acute diarrhoea, especially in vulnerable groups where rapid resolution of symptoms is required. A reduction in symptom duration could translate directly to reduced healthcare costs and socioeconomic burden — a significant finding for primary care prescribing decisions.

Acute diarrhoea affects millions of people each year and is one of the most common reasons for primary care consultations. Access to a safe, drug-free option that demonstrably shortens the duration of illness — without the risks associated with opioid-based antidiarrhoeals — represents a meaningful addition to the clinician’s toolkit.

“The acute diarrhoea study showed that Enterosgel® can reduce the duration of acute diarrhoea and relieve associated symptoms, and is one of the few safe treatment options currently available for children.”

Dr Preeti Pandya — Chief Investigator, Acute Diarrhoea Study · The Village Practice, Thornton-Cleveleys, UK


The investigators

About the research team

Authors — BMJ Open Gastroenterology 2019

Prof. Ramesh Arasaradnam — Principal Investigator

Department of Academic Gastroenterology, University Hospital Coventry & Warwickshire (UHCW), Coventry, UK. Faculty of Health and Life Sciences, University of Coventry, Coventry, UK.

Dr Preeti Pandya — Chief Investigator

The Village Practice, Thornton-Cleveleys, UK.

Dr Carol Howell

Research Director, Enteromed Ltd. University of Brighton, School of Pharmacy & Biomolecular Sciences, Brighton, UK.

Read the full clinical evidence for Enterosgel®

Including all published clinical trials, NHS Drug Tariff listing, and resources for healthcare professionals and patients.

View the research →
Note for healthcare professionals: This summary is intended for informational purposes. The full article is available via BMJ Open Gastroenterology. Enterosgel® is a CE Class IIa registered medical device indicated for acute diarrhoea and diarrhoea associated with IBS-D.

References

  1. Arasaradnam R, Pandya P, Howell C et al. Enterosgel (polymethylsiloxane polyhydrate) for the treatment of adults with acute diarrhoea in a primary care setting: a randomised controlled trial. BMJ Open Gastroenterology 2019.
  2. Howell CA et al. Double-blinded randomised placebo controlled trial of enterosgel for the treatment of IBS with diarrhoea (IBS-D). Gut 2022;71:2430–2438. doi:10.1136/gutjnl-2022-327293
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