In order to demonstrate the effect of Entersgel in irritable bowel syndrome, and thereby significantly help to make life easier for people with this condition, a double-blind, randomised, placebo-controlled trial was conducted in the UK in 2022 and published online for the first time on 27 June 2022 in the prestigious journal GUT.
What was the purpose of the study?
It aimed to determine the safety and effectiveness of Enterosgel in patients with irritable bowel syndrome with diarrhoea (IBS-D).
Preparation and selection of participants
Before the study started, participants underwent a two-week screening phase to make sure they were suitable.
Note: The screening phase is as a check-up before the main part of the study begins. During this phase, the researchers make sure that the participants are suitable for the study. They may carry out tests, ask about medical history and check if there are any reasons why someone should not take part in the study. It's a bit like getting the go-ahead before starting a trip: making sure everything is to proceed.
Plan of the study
Participants were enrolled in an 8-week double-blind phase followed by an 8-week open-label phase.
Note: In the double-blind phase of the study, neither the participants nor the researchers know who is receiving the actual treatment and who is receiving the placebo. This is done to avoid bias and to ensure that the results are as accurate as possible. It's like a secret test where no one knows who is getting what until the end.
In the open phase, everyone knows who is getting the real product. This part usually follows the double-blind phase. It helps researchers get additional information about how well the real treatment works when everyone knows what they are taking. It's like opening up a test and taking an open look at the results.
During the study, participants tracked stool consistency, abdominal pain and other parameters related to IBS-D using electronic diaries and questionnaires. In particular, the researchers looked at how many people had a positive response according to predetermined criteria.
To find out, they looked at two things:
- Abdominal pain: whether participants' abdominal pain decreased by at least 30% each week.
- Stool consistency: whether, participants were half as likely to have thin or watery stools (type 6 or 7 on the stool scale).
- If someone met both of these conditions for at least four weeks of treatment, they were considered a “responder”.
Course of the study
A total of 440 people with irritable bowel syndrome with diarrhoea participated in the double-blind phase, with 393 of them continuing to the open-label phase. The study found that Enterosgel helped more than placebo in improving symptoms (37.4% versus 24.3%).
The study also found that Enterosgel helped not only with diarrhoea, but also with pain, urge to expel and bloating, and people with irritable bowel syndrome with diarrhoea improved stool consistency.
Digging deeper, the study found other benefits: stool consistency improved in more people (48.5% vs. 32.5%), abdominal pain decreased (53.3% vs. 40.2%), and frequency of defecation and urge to defecate improved. Furthermore, It is impressive that 60% of patients reported experiencing sufficient symptom relief after the open-label phase compared to placebos.
Conclusion of the study
Based on the results of the study, Enterosgel has tremendous benefits for people with irritable bowel syndrome with diarrhoea (IBS-D):
- Effective Symptom Relief: Enterosgel has demonstrated significant effectiveness in relieving symptoms commonly associated with Irritable Bowel Syndrome with Diarrhea, including diarrhoea, abdominal pain, stool urges, and bloating. Compared to placebo, a higher percentage of participants experienced relief from these symptoms when taking Enterosgel.
- Improved stool consistency: the study showed that Enterosgel helped to improve stool consistency in patients with irritable bowel syndrome. This is important because IBS-D is characterized by frequent thin or watery stools, and a more normal stool consistency can significantly improve the quality of life for these individuals.
- Positive effect on abdominal pain: Enterosgel is particularly effective in reducing abdominal pain in patients with irritable bowel syndrome with diarrhoea. This is a significant benefit, as abdominal pain is one of the most bothersome and disruptive symptoms experienced by individuals with IBS-D.
- Safety Profile: Importantly, the study showed the safety of Enterosgel for use in irritable bowel syndrome with diarrhoea.
The study indicates that Enterosgel is indeed an appropriate therapy for people with IBS-D. It helps with symptoms, normalizes stools, and is safe to use.
This makes Enterosgel a great choice to help with irritable bowel syndrome therapy and leads to an improved quality of life for all those in need.