Introduction

Since the global emergence of the COVID-19 pandemic in Spring 2020, numerous bariatric units worldwide have indefinitely postponed elective weight loss procedures, responding to the heightened risk profile associated with obesity during viral infections. Concomitantly, lockdown measures have led to significant lifestyle changes, notably reductions in physical activity and increases in food consumption, collectively contributing to weight gain in various populations. Intragastric balloons, recognized as effective means for initiating weight loss or serving as an interim solution before bariatric surgery, require upper endoscopy for insertion and removal. These procedures have faced significant disruptions due to the pandemic-driven reallocation of medical resources, including anesthesiologists and endoscopic services.

Aims & Methods

This study aims to evaluate the feasibility and safety of employing the Allurion Elipse® gastric balloon, an innovative device designed for administration without anesthesia or endoscopic guidance. This device could potentially reduce patient risk and conserve valuable hospital resources in times of medical crisis. A selected group of obese patients, as determined by our multidisciplinary bariatric team, were administered an encapsulated pill balloon, which, once ingested, expands with 550mL of fluid under the direct supervision of a gastroenterologist. Placement accuracy was confirmed through X-ray imaging. Alongside the physical intervention, patients received comprehensive support, including a customized diet plan, access to a digital health application connected to a weighing scale for remote monitoring, and regular virtual follow-ups. The primary measure of clinical efficacy was the percentage of total body weight loss (%TBWL).

Results

The study included seventeen consecutive patients (11 females, 6 males) with a mean age of 43.7 ± 9.9 years. These individuals had a mean weight of 104.21 ± 21.72 kilograms and a mean BMI of 36.11 ± 4.7 kg/m2. The balloon positioning procedures were efficiently completed in 20 to 30 minutes without technical complications. Most patients reported transient nausea and vomiting. However, these symptoms were manageable and did not lead to any severe adverse events. Only one patient required early balloon removal due to intolerance. After eight months of the procedure, with the balloon passing naturally four months prior, two patients reported a %TBWL of 19.8. The average %TBWL recorded at the four-month mark was 13%, and the weekly check-in compliance rate was 62%.

Conclusion

The COVID-19 pandemic has drastically impacted the availability and functionality of bariatric and endoscopic services, prompting the need for alternative methods that simplify and expedite the weight loss process. Although limited, the available data support the Allurion Program with the Elipse Balloon as a non-invasive, secure, and effective method to manage obesity. It facilitates rapid and sustainable weight loss, enables continuous remote support, and minimizes the impact on patients and the already strained health systems. This method represents a valuable alternative to traditional approaches, particularly during healthcare resource constraints.

References

Tønnesen CJ, et al. A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial. Scand J Gastroenterol. 2022
Mauro A., et al. A Comprehensive Review on Bariatric Endoscopy: Where We Are Now and Where We Are Going. Medicina (Kaunas). 2023
Navarra, G, et al. Bariatric surgery and the COVID-19 pandemic: SICOB recommendations on how to perform surgery during the outbreak and when to resume the activities in phase 2 of lockdown. Updates Surg. 2020
Vargas EJ, et al. Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population. Clin Gastroenterol Hepatol. 2018
Kumar N, et al. The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis. Obes Surg. 2017

Introduction

A strict lifelong gluten-free diet (GFD) is the mainstay of treatment for coeliac disease (CD). However, persistence of gastrointestinal symptoms in coeliac patients despite a GFD is a relevant clinical scenario. The impact of highly processed foods (HPF) intake and the adherence to a correct Mediterranean diet (MD) on these symptoms, the quality of life (QOL), and the metabolic profile of coeliac patients on a GFD is not well understood. This study aimed to investigate the influence of HPF and MD on gastrointestinal symptoms, QOL, and metabolic profile in coeliac patients on a GFD. We hereby present partial data of this ongoing study.

Aims & Methods

Adult CD patients were prospectively enrolled between November-2023 and March-2024 at four Italian referral centers. For each enrolled patient, the following data were recorded: persistent symptoms over the previous 12 months and in the 7 days prior to enrolment by using the GSRS-CeD, adherence to a GFD, adherence to a MD evaluated by means of the Pyramid-based Mediterranean Diet Score (PyrMDS), the consumption of highly processed food evaluated by means of the sQ-HPF, the Celiac Disease-specific Quality of Life Scale (CD-QOL) and metabolic profile. These data were subsequently statistically analized.

Results

A total of 121 patients (83F, mean age 44±15 years) were enrolled. Overall, 61% of patients reported persistent gastrointestinal symptoms despite a GFD. Patients with persistent symptoms were more likely to be female (78% vs 53%, p<0.01), to have a lower HPF intake (26% vs 30%, p=0.02), a higher GSRS-CeD score (median 3 vs 18.5, p<0.001), and lower CD-QoL scores (mean CD-QoL 80 vs 88, p<0.001), but did not have higher PyrMDS scores (p=0.21). PyrMDS was inversely correlated with HPF intake (r=-0.20, p=0.03) and serum triglycerides (r=-0.22, p=0.05), and positively correlated with HDL cholesterol (r=0.20, p=0.08). At multivariate logistic regression adjusted for age and sex, persistence of gastrointestinal symptoms despite a GFD was associated with female sex (p<0.01), lower HPF intake (p=0.04), but not adherence to MD (p=0.31).

Conclusion

Persistence of gastrointestinal symptoms in coeliac patients despite a GFD is common, but unrelated to the adherence to a MD. Female sex and lower intake of HPF were associated with persistence on gastrointestinal symptoms despite a GFD despite a better metabolic profile. Optimising dietary treatment of coeliac patients with persistent gastrointestinal symptoms despite a GFD requires expert nutritional counselling.