Participants’ abdominal pain intensity dropped by 50% over one month of taking the Gastrap Direct treatment, according to a study published in World Journal of Gastrointestinal Pharmacology and Therapeutics by Caroline Valibouze, researcher at Lille University Hospital, France, and colleagues .
Additionally, by two weeks of treatment, 58% of the patients reported very much/considerable relief in their abdominal pain via a satisfaction questionnaire. This figure rose to 66% by the end of the four-week treatment period.
The study “confirms that our combination effectively alleviates IBS symptoms through its unique mode of action,” Benoit Palms, chief business officer of the Belgian firm BiOkuris, which partook in the study, told NutraIngredients. “It underscores the potential of targeted combinations of nutraceuticals, and in this particular case, of fungal chitin-glucan, to provide meaningful relief for IBS patients, emphasizing the importance of mechanism-specific research in this field.”
Testing Gastrap Direct in IBS
IBS is a common chronic gastrointestinal condition where the bowels change how they function and lead to recurrent abdominal pain. The few treatments available include antispasmodics, laxatives, loperamide, which are targeted to treat pain, constipation and diarrhea respectively, but have only a limited benefit, says the study.
Gastrap Direct, which is commercially available in some countries, consists of sachets that contain 500 mg of chitin-glucan, which can reduce pain and promote the growth of beneficial gut bacteria such as Roseburia spp. The sachets also contain 250 mg of sorbitol, silicon dioxide, acacia gum, xanthan gum, sucralose, acesulfame K and the silicone compound simethicone, which is designed to reduce flatulence, write the researchers.
The study recruited adults between the ages of 18 and 75 diagnosed with IBS according to the Rome IV criteria, which includes a score of 2 or more on the visual analog scale (VAS), a metric ranging from 0 to 10 that can be used to quantify bloating or abdominal pain.
The 100 enrolled participants received Gastrap Direct after meals with one stick during the first three days of the study, increasing to two sticks per day for another three days, and then three sticks per day until the end of the study.
Among the participant population, 76% were women and had a mean age of 47 years, with 38% having constipation-predominant IBS, 32% having diarrhea-predominant IBS and 20% having mixed IBS. A total of 67% of the patients had a normal stool consistency, scoring between 3 and 5 on the Bristol stool scale, a 7-point scale where a higher score means more liquid stool.
The investigators found that the participant compliance rate was 88% over the month of treatment, as assessed by returned packaging and interviews with participants. Abdominal pain intensity dropped from a mean VAS of 5.8 to 2.9 over the treatment period and 67% of participants overall responded to the treatment, indicated by a VAS score improvement of 30% or more.
Meanwhile, there was a 40% improvement in bloating and abdominal distension, whose VAS scores dropped from 8.0 to 4.7 and from 7.2 to 4.4 after four weeks respectively. The respective responder rates for bloating and abdominal distension were 60% and 53%.
Valibouze and colleagues observed that the improvements in IBS symptoms were similar irrespective of whether the patients had prevalent constipation, prevalent diarrhea or mixed symptoms. This finding makes the treatment “unique, as it addresses the diverse spectrum of symptoms seen in different IBS subtypes, providing a comprehensive therapeutic option for a wider range of patients and thus increasing patient adherence,” Palms said.
The treatment also reduced the impact of the participants’ symptoms on their daily life by 35% by the end of the treatment period as measured by the VAS. Among those with liquid stool at baseline, around 90% saw their stool consistency return to normal levels, and 58% saw very much/considerable relief from diarrhea by four weeks of treatment.
Valibouze et al. observed no serious adverse effects in the study, and 93% of patients reported that the treatment had a good or very good tolerability.
Further development
Gastrap Direct is already being marketed by BiOKuris and is regulated by the EU as a class IIa medical device. BiOkuris’ management has no immediate plans for a larger, placebo-controlled study of the product as the emphasis is on using its current data to drive market adoption and on forging partnerships to expedite market entry, Palms said. The firm is also open to collaborations to expand Gastrap Direct to markets in new geographies.
Some of the biggest challenges to address in the general IBS landscape include a lack of objective diagnostic tests, which can lead to delays in diagnosis, and limited access to second-line pharmacological treatments, such as intestinal secretagogues, particularly in less affluent countries, Palms said. He added that non-pharmacological approaches including psychotherapy and cognitive behavioral therapy are “underutilized due to clinicians' limited awareness, a shortage of trained professionals and cultural barriers.”
Routes that the researchers aim to follow up in future include the potential targeting of sensory cells in the gastrointestinal tract in IBS and the other complex interactions within the gut-brain-microbiota axis, Palms said.
“The versatile nature of our fungal chitin-glucan allows us to look into those two key areas, making it especially interesting to identify the best combinations possible with other ingredients to develop products that are tailored to a patient’s needs—not only for IBS but even beyond like for gastrointestinal or even metabolic disorders,” he added.
Source: World J Gastrointest Pharmacol Ther. 2024, 15(3): 90757
“Efficacy and tolerability of chitin-glucan combined with simethicone (GASTRAP® DIRECT) in irritable bowel syndrome: A prospective, open-label, multicenter study”
doi: http://dx.doi.org/10.4292/wjgpt.v15.i3.90757
Authors: Nathalie Talbodec et al.