Introduction

Endoscopic sleeve gastroplasty (ESG) is a safe and effective procedure in class 1 and 2 obese subjects.The effects of menopause on weight are well known. However, given that this patient population is inherently weight-concerned, understanding the effects of ESG on women in menopause is essential to guiding clinicians in counselling this patient population.

Aims & Methods

A prospective dataset collecting data on all ESG procedures performed in a tertiary referral centre was assessed retrospectively. Data on fertility status (menopause and non-menopause women) were collected. A comparison was performed using the Mann-Whitney U test.

Results

Between May 2017 and October 2021, 209 women underwent ESG. Out of the total, fertility status was available for 204 women: 79 menopause (M; 38,7%) and 125 non-menopause women (NM; 61,3%).At baseline, non-menopause women were younger, whereas there were no differences in BMI and weight.
Adherence to follow-up was 92,4%, 87,3% and 80,0% for menopause, 88,8%, 90,4% and 72,9% for non-menopause, at 6,12 and 24 months, respectively.
Six months after the procedure, non-menopause women showed significantly higher TBWL, WL and BAROS score compared to the menopausal group. In contrast, EWL showed no significant difference between the groups.Average TBWL, WL and EWL were not significantly different between the groups at 12 and 24 months (as shown in Table below).
Seven menopausal women needed revision procedures (5 Re-ESG, 1 Surgery), whereas ten non-menopausal women underwent revision (8 Re-ESG, two surgery).

Table. Weight loss trajectories of subjects who underwent Endoscopic Sleeve Gastroplasty, based on menopausal status. Data are reported as median (Interquartile range).

		WL (kg)	EWL (%)	TBWL (%)	BAROS
6-months follow-up	Menopause (n=73)	15,0 (10)	50,8 (24,7)	15,2 (8,6)	3,5 (1,5)
	Non-menopausa (n=111)	17,0 (9,0)	54,9 (34,6)	17,2 (8,6)	4,0 (2,0)
	p	0,017	0,068	0,0190	0,039
12-months follow-up	Menopause (n=69)	13,0 (11,0)	47,8 (31,4)	14,1 (13,0)	3,5 (2,3)
	Non-menopausa (n=113)	16,0 (13,5)	52,5 (41,5)	16,3 (13,5)	3,5 (2,8)
	p	0,162	0,318	0,223	0,506
24-months follow-up	Menopause (n=40)	13,0 (15,6)	40,5 (39,3)	13,6 (14,8)	2,6 (2,9)
	Non-menopausa(n=62)	10,0 (11,8)	35,4 (45,0)	10,4 (13,4)	2,5 (3,4)
	p	0,4	0,716	0,519	0,776

Conclusion

Non-menopausal women who undergo ESG show better outcomes in the short term. However, this advantage does not persist in the medium and long term.

Introduction

Capsule endoscopy is the first-line examination for digestive bleeding with likely origin in the small bowel, in hemodynamically stable patients. In the 2022 update, ESGE guidelines recommend that, in the context of overt bleeding, capsule enteroscopy should be performed as soon as possible, ideally within the first 48 hours. In the previous guidelines, published in 2015, the recommended window was 14 days.

Aims & Methods

This study aimed to evaluate the improvement in yield offered by the new recommendations regarding the timing of urgent capsule enteroscopy. Patients with suspected overt middle gastrointestinal bleeding between January 2005 and November 2022 were retrospectively analyzed. Diagnostic and therapeutic yield, rebleeding rate, and mortality were compared when capsule enteroscopy was performed within the first 48 hours, within the first 14 days, or between the 3rd and 14th day after admission.

Results

A total of 138 patients were included (58.7% men, median age 66 years), 87 of whom (63.0%) underwent capsule enteroscopy within the first 48 hours after hospital admission. The median follow-up was 55 months (5-180). The diagnostic yield (presence of blood or lesions with bleeding potential) was slightly higher when capsule enteroscopy was performed within the first 48 hours (81.6% versus 76.5%, p=0.349). On the other hand, capsule enteroscopy within the first 48 hours was significantly associated with higher therapeutic yield (endoscopic, radiologic, or surgical treatment) - 54.0% versus 39.2%, p=0.02. The rebleeding rate was significantly lower in patients undergoing enteroscopy within 48 hours after admission (19.5% versus 29.4%, p=0.04). On the other hand, overall mortality at 36 months did not differ between strategies (21.8% and 25.5%, p=0.401).

Conclusion

Performing capsule endoscopy within the first 48 hours, as recommended by recently published guidelines, is associated with favourable short- and long-term clinical outcomes.

Introduction

Patients with type 2 diabetes are prone to the development of dysbiosis, which can manifest as intestinal bacterial overgrowth (SIBO). This may explain the pathomechanism of abdominal symptoms that sometimes affect this group of patients. Disturbances in the composition and quantity of intestinal microbiota translate to impaired production of short-chain fatty acids (SCFA) in the intestinal mucosa. To increase the concentration of butyrate in the lumen of the intestine, oral microencapsulated sodium butyrate supplementation can be proposed. Given the limited research conducted on the topic of the effects of sodium butyrate supplementation in alleviating abdominal symptoms in patients with type 2 diabetes, it became the topic of our interest.

Aims & Methods

The aim of the study was to evaluate the effectiveness of oral sodium butyrate supplementation in the population of patients with type 2 diabetes in alleviating abdominal symptoms and to estimate the incidence of small intestinal bacterial overgrowth in this group. In addition, the impact of the intervention on the carbohydrate metabolism was assessed.A prospective, single-centre, randomized, placebo-controlled study was conducted between October 2022 and April 2023.
52 patients with type 2 diabetes and gastrointestinal symptoms were randomly assigned to one of 2 groups - a group receiving microencapsulated sodium butyrate (Intesta Max) at a dose of 1.5 g/day and a group receiving placebo. As 8 patients (15.3%) were lost to follow-up, for the preliminary analysis 44 patients were included. The study lasted for 6 weeks. Before and after the intervention the presence of abdominal pain, diarrhoea, constipation and flatulence was assessed, laboratory tests and hydrogen breath tests were performed, the HOMA index and body mass index were calculated.

Results

At baseline SIBO was diagnosed in 73.1% of patients in the experimental group and 58.8% of patients in the control group. After 6 weeks of the intervention there was a significant drop in SIBO occurrence in sodium butyrate group – 22.2% (p=0.001). The incidence of SIBO in the control group did not change – 64.7% (p=0.21).All patients included in the study declared abdominal pain before the intervention. After 6 weeks the pain was reported by 42.3% of the patients receiving the sodium butyrate vs. 88.4% of the patients receiving placebo (p=0.002). After the intervention there was a significant difference between the groups regarding diarrhea – 18.5% and 58.8% (p=0.006) in sodium butyrate and placebo groups respectively. A decrease in the incidence of bloating in the sodium butyrate group was observed - 100% before vs. 29,6% after the intervention (p<0.00001). The study also showed a decrease in BMI level, the HOMA index and glycated hemoglobin level after consumption of the sodium butyrate vs. placebo for 6 weeks. These results need confirmation in a larger group.

Conclusion

To our knowledge this is the first study reporting the effectiveness of oral butyric sodium supplementation in relieving abdominal symptoms (abdominal pain, diarrhea, flatulence) in patients with type 2 diabetes. Furthermore, an improvement in carbohydrate metabolism parameters was noted and body weight decrease was observed after the intervention.

Disclosure

Sodium butyrate (Intesta Max) we received from the company that produces it.

Introduction

Obesity, one of the most common co-morbidities in women of reproductive age, contributes to infertility and obesity-related pregnancy complications. On the other hand, pregnancy is a condition in which, physiologically, the pregnant woman undergoes weight gain. Endoscopic Sleeve Gastroplasty (ESG), an organ-sparing bariatric procedure aimed to reduce gastric volume and modify gastric motility with full-thickness endoscopic sutures, may be used for the treatment of obesity in women of childbearing age.

Aims & Methods

A retrospective analysis of a prospective database was conducted to evaluate weight trajectories, the evolution of obesity-related comorbidities, and lifestyle modification in women who became pregnant after ESG.
A comparison was made between childbearing-age women who became pregnant after ESG and non-pregnant women who reached at least the 6-month follow-up after ESG.

Results

Between January 2018 and December 2021, a total of 150 childbearing-age women underwent ESG at a large Italian tertiary medical center. Out of the total, 18 patients (12,0 %) reported a desire for pregnancy associated with unsuccessful attempts in the 12 months preceding ESG.
Eleven patients (mean age 33,4±6,2 years) became pregnant after the procedure, following a mean time interval of 5,5±3,9 months. The mean preconception BMI was 31,9±4,0 kg/m² (with a mean reduction of 7,24±4,0 kg/m² after ESG). Three patients were affected by hyperinsulinemia (H-INS), while an additional patient had both H-INS and high blood pressure (HBP). Three women reported difficulty in becoming pregnant before the ESG: two were affected by PCOS.
Total body weight loss (TBWL) of at least 5% was achieved before pregnancy in all patients (73% reached a TBWL ≥ 10%).
Six out of eleven (55%) patients had weight gain in the ranges recommended by the Institute of Medicine (IOM) during pregnancy. Among the 18 women with a reported desire for maternity associated with difficult attempts in the previous 12 months, 16,6 % (3/18) managed to start and carry out a pregnancy.
TBWL (%) was 18,08±8,00, 10,35±11,53, and 12,08±8,49, at the beginning of pregnancy, at the delivery, and at the first follow-up (mean interval, 5,18±3,57 months).
No significant differences in WL, TBWL, EWL, BMI, BAROS, and QoL were found between the pregnancy and non-pregnancy groups (99 childbearing-age women) up to 24 months after ESG.

Conclusion

ESG produces adequate weight loss before pregnancy in patients with obesity and is potentially a useful treatment option for women who have difficulty becoming pregnant, such as those with PCOS. Pregnancy after ESG does not adversely affect weight loss outcomes after delivery as lifestyle changes induced by ESG are maintained after pregnancy and allow for a gradual loss of weight gained during pregnancy.

Introduction

Ustekinumab has been proven to be effective for treatment of patients with Crohn's disease; however, 30–40% of patients have been reported to lose clinical response within 2 years. We aimed to evaluate the efficacy of ustekinumab and identify predictors of short- and long-term efficacy in Crohn's disease.

Aims & Methods

Patients with Crohn's disease receiving their first ustekinumab infusion in our hospital between June 2017 and September 2020 were prospectively enrolled. Concentrations of serum cytokines and chemokines were measured using a multiplex bead array assay. Trough concentration of ustekinumab in serum samples collected after 8 weeks of intravenous administration were measured by ELISA.

Results

Fifty-nine Crohn's disease patients were enrolled in this study. Among 34 clinically active patients, 38.2% achieved a clinical response at week 8. None of the assayed factors were associated with short-term clinical response. Cumulative persistence rates of ustekinumab were 77.6% at 1 year and 58.9% at 2 years. Univariate Cox regression analysis revealed that Harvey–Bradshaw Index scores at baseline, concomitant immunomodulator treatment, and concentrations of interferon gamma-induced protein-10, monocyte chemoattractant protein-1 (MCP-1), and interleukin (IL)-1RA, IL-4, IL-6, and IL-8, but not other baseline parameters and trough concentrations of ustekinumab (hazard ratio (HR): 0.9846, 95% confidence interval (CI): 0.9561–1.014), were significantly associated with loss of efficacy. Multivariate Cox regression analysis found that biologic naïve status (HR: 0.1264, 95% CI: 0.02595–0.6158) and MCP-1 concentrations (HR: 1.037, 95% CI: 1.014–1.062) were significantly and associated with loss of sustained efficacy for ustekinumab treatment.

	Univariate analysis HR	Lower limit of the 95% CI	Upper limit of the 95% CI	p value	Multivariate analysis HR	Lower limit of the 95% CI	Upper limit of the 95% CI	p value
Biologic naïve, Yes	0.2367	0.05582	1.004	0.05061	0.1264	0.02595	0.6158	0.01047
Concomitant IM, Yes	2.644	1.144	6.113	0.02297
IL-4, pg/mL	1.562	1.028	2.375	0.03685
IL-6, pg/mL	1.07	1.02	1.123	0.00568
IL-8, pg/mL	1.067	1.025	1.111	0.001415
IL-1RA, pg/mL	1.003	1.001	1.005	0.00439
IP-10, pg/mL	1.001	1.001	1.001	0.02067
MCP-1, pg/mL	1.022	1.003	1.04	0.02055	1.037	1.014	1.062	0.001754
Trough level of UST at week 8	0.9846	0.9561	1.014	0.3029

Furthermore, if patients were divided into four groups according to prior biologics use and MCP-1 level which cut-off value was determined from receiver operating characteristics (ROC) at 1 year, MCP-1 low and biologics naïve group had 100% cumulative persistence rate of ustekinumab at week 140. On the other hand, MCP-1 high and biologics exposure group had below 20%.

Conclusion

Our findings suggest that pre-treatment serum MCP-1 analysis, combined with a history of biologic use could be a novel biomarker for predicting the long-term efficacy of ustekinumab in patients with Crohn's disease. However, predicting of long-term efficacy by a trough concentration of ustekinumab at week 8 might be limited.

Disclosure

The authors declare no conflicts of interest associated with this manuscript.

Introduction

Transmural response (TR) and healing (TH) assessed by intestinal ultrasound (IUS) are gaining increasing relevance as treatment targets in Crohn’s disease (CD) [1]. Even though less established in ulcerative colitis [UC], in which the inflammation mainly affects mucosa and submucosa, there is clear evidence that applying IUS in UC is beneficial to monitor short-term response to therapy [2]. However, the long-term IUS outcome, its association to clinical and lab parameters as well as the predictive value of early TR remain elusive.

Aims & Methods

The TRUST BEYOND study is an ongoing, prospective, non-interventional, multi-centre study in patients with active CD or UC who receive a biologic- or Januskinase-inhibitor (JAKi)-therapy at baseline. The study aims to assess the predictive value of TR or TH, evaluated at week 12 for the disease outcome after 52 weeks (TR: reduction of bowel wall thickness (BWT) of at least 25% and/or normalization; TH: normalization of BWT and Colour Doppler signal). For this interim analysis, we report IUS and clinical results as well as fecal calprotectin levels of 77 UC patients on the same therapy after 12 (W12) and 52 weeks (W52) and assessed the predictive value of TR at W12 for clinical remission at W52.

Results

Seventy-seven UC patients (63.6% were male, median age was 38.6 years (30.6 – 55.7) median disease duration of 5.85 years (2.49–12.77)) with clinically active disease (SCCAI 8.5 ± 2.2) with increased BWT at baseline had a documented visit after 52 weeks until February 2023. For the vast majority, the most affected bowel wall segment was the sigmoid colon with a mean BWT of 5.22 ± 1.28 mm at baseline.
At W12 after induction of therapy, the proportion of UC patients with TR and TH was 67.5% (n = 52) and 31.2% (n = 24). At W52, the rates of UC patients increased to 77.9% (n = 60) for TR and 41.6% (n = 32) for TH. Over the study course, patients with TR at W12 and W52 had a numerically lower SCCAI score and reduced fecal calprotectin levels than patients without TR.
Of note, 72.2% (n = 39) of patients with TR at W12 were in clinical remission at W52 compared to 27.8% (n = 15) of patients without early transmural response (p = 0.178).

Conclusion

In this interim analysis of the TRUST BEYOND study, UC patients demonstrated substantial rates of transmural improvements on IUS after 12 and 52 weeks. Patients with early transmural response were more likely to be in remission after one year. This suggests that in UC, IUS has to some degree a predictive value as observed for CD.

References

1. Kucharzik T, Wittig BM, Helwig U, et al. Use of Intestinal Ultrasound to Monitor Crohn's Disease Activity. Clin Gastroenterol Hepatol. 2017; 15:4, 535-42 e2.
2. Maaser C, Petersen F, Helwig U On behalf of the German IBD Study Group and the TRUST&UC study group, et alIntestinal ultrasound for monitoring therapeutic response in patients with ulcerative colitis: results from the TRUST&UC studyGut 2020;69:1629-1636.

Disclosure

T. Kucharzik, U. Helwig, F. Seibold, L. Biedermann, C. Högenauer and C. Maaser have received lecture and consulting fees from AbbVie.
I. Fischer has received consulting fees from AbbVie. L. Hammer and S. Rath are AbbVie employees and may own AbbVie stock or options.
AbbVie sponsored the study; contributed to the design; participated in the collection, analysis, and interpretation of data; in writing, reviewing, and approval of the final version. No honoraria or payments were made for authorship.