Efficacy and Safety of Pea Protein and Xyloglucan Versus Simethicone in Functional Abdominal Bloating and Distension.

BACKGROUND: Functional Abdominal Bloating and Distension (FABD) is a multifaceted condition related in part to trapped gas, with changes in the intestinal barrier and small intestinal bacterial overgrowth (SIBO), which lead to gas production. Currently, there are no treatments targeting the etiology of FABD. METHODS: This double-blind, multicenter, randomized study evaluated the safety and efficacy of a product containing xyloglucan and pea proteins (XG + PP) compared with simethicone, both administered orally (three times daily) for 20 consecutive days. Eighty-eight patients with FABD were randomly assigned to the two groups in a 1:1 ratio. Primary outcome was safety; secondary outcomes were (i) efficacy in alleviating the symptoms of FABD and (ii) efficacy in reducing SIBO, as assessed by hydrogen breath test (HBT). RESULTS: No Adverse Events or Serious Unexpected Adverse Reactions were reported during the study. XG + PP showed a faster onset of action and a significant reduction in bloating and abdominal pain compared with simethicone. At Day 20, XG + PP drastically reduced abdominal girth when compared with simethicone, with an average reduction of 4.7 cm versus 1.8 cm. At Day 20, the XG + PP arm showed a significant reduction in HBT compared to baseline. CONCLUSIONS: This study supports the evidence that FABD patients may benefit from a XG + PP-based treatment that acts on etiology and not just the symptoms.

Topical Application of a Formulation Containing Pea Proteins and Xyloglucan in Adult Patients with Atopic Dermatitis: A Double-blind, Parallel, Randomized, Placebo-controlled, Multicenter Study.

Objective: Atopic dermatitis (AD) management requires long-term use of drugs that come with side effects. Compounds such as xyloglucan (XG) and pea proteins (PP) are emerging alternatives to corticosteroids that have shown to restore skin barrier function in preclinical studies. This double-blind, parallel, randomized, placebo-controlled clinical trial investigated the efficacy and safety of XG and PP, in adult AD patients. Methods: Fourty-two patients with AD were randomly assigned 1:1 to receive a XG+PP treatment or the vehicle without XG+PP twice/day for 14 consecutive days for assessment at baseline, Day 8 and Day 15; follow-up visit was 14 days after the end of treatment (Day 28). Efficacy was evaluated using the Scoring Atopic Dermatitis (SCORAD) index, AD severity index (ADSI) score and patient-oriented eczema measure (POEM). Safety and tolerability were monitored as the occurrence of Adverse Events (AEs). Results: At baseline, both groups exclusively included moderate/severe AD cases. At Day 8, six patients treated with XG+PP displayed complete resolution of AD, while 15 patients had mild AD. At Day 28, 16 patients no longer had eczema, whereas five patients displayed mild AD. Notably, 21 patients in the vehicle group still displayed moderate/severe AD. Conclusion: XG and PP promote rapid and long-lasting relief, supporting its use as a safe alternative to mainstay corticosteroid treatments for AD management. The study protocol has been registered in the ISRCTN registry (TN66879853).