Introduction

Helicobacter pylori infection involves a high proportion of the Colombian population (1). It has been established that Helicobacter pylori infection increases the risk of developing gastric cancer (2). Multiple treatment regimens have been proposed to eradicate Helicobacter pylori, but it is not known which one could be associated with the best eradication rate in our population (3).

Aims & Methods

The aim of this research was to determine the factors most associated with the successful eradication of Helicobacter pylori in an adult population in Colombia.
An analytical cross-sectional study was conducted to assess risk factors associated with the eradication of Helicobacter pylori in an adult population in Colombia. The cross-sectional design facilitated data collection at a specific time point, while the analytical approach aimed to uncover connections between risk factors and the success of eradication.
A sample size calculation was performed for logistic regression using the Freeman formula. Based on estimated proportions of patients experiencing treatment failure, an approximate sample size of 400 patients was determined for the evaluation of 10 variables. Participant patients were adults diagnosed with Helicobacter pylori infection who were prescribed eradication treatment and underwent verification of eradication between January 1, 2022, and December 31, 2022. Patients with incomplete information, the pediatric population, or those without eradication verification were excluded from the analysis.
A descriptive analysis was conducted to characterize the sample and risk factors. Subsequently, a bivariate analysis examined the relationship between each independent variable and Helicobacter pylori eradication. Variables with a p-value < 0.05 in the bivariate analysis were included in a multivariate logistic regression model to identify independent risk factors associated with successful eradication. The multivariate analysis was adjusted for treatment adherence and compliance.

Results

Variable	Odds ratio	95% Confidence Interval		p value
Proper treatment adherence*	13.72	3.1840	59.0874	< .001
Regimen with esomeprazole	4.97	1.1034	22.3592	0.037
Regimen with bismuth	2.04	1.1580	3.5977	0.014
Duration of the regimen: 14 days	7.21	1.2304	42.2908	0.029
Lactobacillus reuteri	1.79	0.8633	3.7249	0.117
Eradication regimen with amoxicillin	2.58	0.1512	43.9183	0.513
Eradication regimen with clarithromycin	6.88	0.4417	107.1126	0.169
Eradication regimen with metronidazole	6.94	0.4185	115.1961	0.176
Eradication regimen with levofloxacin	11.76	0.7801	177.1968	0.075

Table 1. Multivariable analysis, factors associated with Helicobacter pylori eradication. * Adherence assessed by the Morisky-Green Test.
A total of 386 patients were included in the study, of whom 74% achieved successful eradication of Helicobacter pylori. The multivariate analysis identified factors associated with successful eradication of Helicobacter pylori: proper adherence to the treatment, the inclusion of esomeprazole and bismuth subsalicylate in the treatment, and a eradication regimen duration of 14 days (Table 1).

Conclusion

Our results support the promotion of treatment regimens lasting 14 days. Strategies to ensure proper adherence to treatment should be encouraged, always incorporating esomeprazole and bismuth subsalicylate in the regimen.

References

1. Virulence Genes of Helicobacter pylori Increase the Risk of Premalignant Gastric Lesions in a Colombian Population - PMC [Internet]. [citado 12 de agosto de 2023]. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9534724/
2. Valladales-Restrepo LF, Correa-Sánchez Y, Aristizábal-Carmona BS, Machado-Alba JE. Treatment regimens used in the management of Helicobacter pylori in Colombia. Braz J Infect Dis. 16 de febrero de 2022;26(1):102331.
3. Piazuelo MB, Bravo LE, Mera RM, Camargo MC, Bravo JC, Delgado AG, et al. The Colombian chemoprevention trial. Twenty-year follow-up of a cohort of patients with gastric precancerous lesions. Gastroenterology. marzo de 2021;160(4):1106-1117.e3.

Disclosure

The authors declare no conflict of interest.

Clinical Case Summary

Intestinal involvement in systemic lupus erythematosus (SLE) is usually due to vasculitis that predominantly affects the small bowel (1, 2). The coexistence of lupus and inflammatory bowel disease (IBD) is uncommon (1), with a prevalence of 0.4% in ulcerative colitis and even lower in Crohn's disease (2). Drug-induced lupus is more common than lupus associated with IBD itself (2). Moreover, when both conditions coexist, it usually involves systemic lupus rather than oligosymptomatic forms (2).
We present a 20-year-old female patient diagnosed with SLE at age 13 with only joint involvement and well-controlled with methotrexate, hydroxychloroquine and oral prednisone that was referred due to diarrhoea with mucus and blood, diffuse abdominal pain and weight loss. A colonoscopy revealed patchy mucosal involvement with deep, medium-sized ulcers in the cecum, left colon, and especially the rectum. The ileum was lesion-free. Histological analysis showed intense acute and chronic inflammatory processes in the colon mucosa, consistent with IBD (clinically suspected Crohn's disease). Signs of vasculitis were not observed. Treatment with oral Mesalamine 3600 mg/day, rectal Mesalamine suppositories and oral corticosteroids led to improved stools, abdominal pain and normalization of inflammatory markers. However, after three months, she was admitted to our hospital due to increased bloody diarrhoea and diffuse abdominal pain, so we decided to treated with infliximab (5 mg/kg). After six months, the patient was asymptomatic with normal laboratory parameters and no signs of inflammatory activity on follow-up colonoscopy.
This case is interesting due to its low prevalence and association with joint-dominant S.L.E. and colonic involvement. Management is similar to CD patients, with positive results seen with infliximab in corticosteroid non-responders (3). The coexistence of both diseases presents a diagnostic and therapeutic challenge that requires multidisciplinary management.

References

1. Jin X;Wang G;Xu X;Bai Y;An R;Jiang D; (2020) Coexistence of crohn's disease and systemic lupus erythematosus: A case report and literature review, European journal of gastroenterology & hepatology. Available at: https://pubmed.ncbi.nlm.nih.gov/32732809/
2. E.V.;, K.K.P. (2012) Inflammatory bowel disease and lupus: A systematic review of the literature, Journal of Crohn's & colitis. Available at: https://pubmed.ncbi.nlm.nih.gov/22504032/
3. Algassim, A. et al. (2021) Systemic lupus erythematosus with crohn's disease: A rare combination and unusual presentation, European Journal of Case Reports in Internal Medicine. Available at: https://www.ejcrim.com/index.php/EJCRIM/article/view/2678

Introduction

Short bowel syndrome (SBS) is the most common cause of intestinal failure (IF) in children and is generally managed using parenteral nutrition and/or intravenous fluids (PN/IV). Long-term PN/IV can cause potentially life-threatening complications. Patients may receive teduglutide (TED) to encourage adaptation of the remaining intestine and to reduce dependence on PN/IV. Short-term studies have shown that TED is effective and has an acceptable safety profile in children and adults with SBS-associated IF (SBS-IF). However, assessment of long-term treatment with TED in paediatric patients with SBS-IF is limited.

Aims & Methods

We report real-world long-term safety and effectiveness data of TED from a paediatric cohort enrolled in the prospective, multinational SBS Registry (NCT01990040; EUPAS7973). Data were analysed cumulatively for up to 6 years between enrolment and interim data cut-off (June 23, 2014 to June 30, 2023). Patients were categorised based on whether they received TED (ever-treated; received ≥1 dose of TED 0.05 mg/kg/day [median]) or never received TED (never-treated; received PN/IV for ≥6 months before study entry). Safety endpoints included: occurrence of colorectal cancer in patients with any remnant colon; other malignancy; colorectal polyps; and adverse events (AEs). Effectiveness endpoints included clinical response (≥20% reduction in PN/IV volume from baseline) and change from baseline in volume of PN/IV (per weight [L/kg]) and number of days/week receiving PN/IV.

Results

In total, 398 paediatric patients were enrolled: 266 never-treated, 132 ever-treated (per-protocol set, n=397; 266 never-treated, 131 ever-treated). Patients had a mean (standard deviation [SD]) age of 5.4 (4.01) years (ever-treated 6.8 [4.12] years; never-treated 4.8 [3.80] years) and the majority were male (63.7%; ever-treated 68.7%; never-treated 61.3%). The median (range) length of exposure in ever-treated patients was 29.0 (1.15–106.61) months.
No new cases of colorectal cancer or new/worsening colorectal polyps were reported between baseline and interim cut-off. New/worsening malignancies were reported for one never-treated patient. A greater proportion of ever-treated patients reported AEs (87.0% vs 74.4%) and serious AEs (SAEs; 72.5% vs 59.0%) than never-treated patients. AEs and SAEs related to TED were reported in 15.3% and 6.1% of ever-treated patients, respectively. There were no allergic or hypersensitivity reactions to TED. The most common TED-related AEs were vomiting (3.8%) and abdominal pain (2.3%). Fatal events were recorded for one ever-treated and three never-treated patients.
A greater proportion of ever-treated patients had achieved a clinical response (year 1, 18/30, 60.0%; year 3, 11/17, 64.7%) than never-treated patients (year 1, 23/100, 23.0%; year 3, 17/82, 20.7%). Ever-treated patients had a greater mean (SD) reduction from baseline in PN/IV volume (L/kg; ever-treated: year 1, −39.4% [35.97], n=19; year 3, −61.6% [23.64]; n=7; never-treated: year 1, −21.1% [50.70], n=80; year 3, −34.4% [36.83], n=49) and number of days/week receiving PN/IV (ever-treated: year 1, −1.6 [2.16], n=30; year 3, −1.5 [1.77], n=17; never-treated: year 1, −1.0 [2.22], n=100; year 3, −0.6 [1.51]; n=82) than never-treated patients.

Conclusion

This 6-year interim analysis of real-world data from a large cohort of paediatric patients with SBS-IF supports that the safety profile of TED is consistent with the previous 5-year follow-up and suggests that TED improves intestinal adaptation in paediatric patients with SBS-IF over a 3-year period.

Disclosure

Palle B Jeppesen: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; commercial relationships as consultant and speaker with Albumedix, ArTara Therapeutics, Baxter, Coloplast, Ferring Pharmaceuticals, Fresenius Kabi, GLyPharma Therapeutic, Ironwood Pharmaceuticals, Naia Pharmaceuticals, NorthSea Therapeutics, Novo Nordisk Foundation, Protara Therapeutics, Takeda, Therachon, VectivBio and Zealand Pharma.
Martina Kohl-Sobania: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; study investigator for NPS Pharmaceuticals and Takeda; honoraria from Aposan, Takeda and Tauro-Implant as a speaker; advisory board member for Takeda.
Francisca Joly: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; study investigator for NPS Pharmaceuticals, Takeda, VectivBio and Zealand Pharma; advisory board member for Alira Health, ArTara Therapeutics, Baxter, M3E Solutions, Takeda, Therachon, VectivBio and Zealand Pharma; commercial relationships as consultant and speaker for Baxter, B. Braun, Fresenius Kabi, Nestlé Health Sciences, Takeda, Therachon and Théradial.
Joel B Mason: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; research support from Takeda as a site for the study; compensation from Care/of, a producer of nutritional supplements; honoraria from UpToDate, a web-based medical information platform, for authoring chapters.
Johane P Allard: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; fees from Takeda as a consultant and speaker, and research support from Takeda as a study site principal investigator (PI); research support from Fresenius Kabi and OMS as a PI; honoraria from Baxter as a speaker and consultant; research support from Zealand Pharma as a site PI.
Ulrich-Frank Pape: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; honoraria from Takeda as a consultant and speaker, and research support from Takeda, VectivBio and Zealand Pharma as a study site PI.
Loris Pironi: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; advisory board member for Baxter, NorthSea Therapeutics and Takeda.
Gabriel E Gondolesi: speaker for Takeda; compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; received investigator-initiated research grant from Takeda.
Lauren K Schwartz: compensation received from Takeda as a member of the Scientific Advisory Committee for the SBS Registry study; speaker for Bristol Myers Squibb; advisory board member for Takeda.
Pinggao Zhang, Sasan Sabrdaran and Yi Wen Huang: employees of Takeda Pharmaceuticals U.S.A., Inc. and receive stock and/or stock options.
André Gabriel: former employee of Takeda Pharmaceuticals U.S.A., Inc. who received stock and/or stock options.

Acknowledgements: This study was funded by Takeda Pharmaceuticals U.S.A., Inc., MA, USA. Medical writing support, funded by Takeda Pharmaceuticals U.S.A., Inc., was provided by Elizabeth Coe, PhD of PharmaGenesis Cardiff, Cardiff, UK.

Introduction

Inflammatory bowel diseases (IBD) are chronic systemic conditions that affect patients' lives in various ways. To date, there is a scarce evidence correlating fecal incontinence, sexual dysfunctions, disease activity, and quality of life (QoL) in these patients. This study aimed to evaluate the impact of fecal incontinence on sexual functions such as erectile and prostatic function in a cohort of IBD patients; and to analyse the relationship among fecal incontinence, sexual function and QoL.

Aims & Methods

IBD patients were enrolled from IBD clinic of the Gastroenterology Unit of the University Hospital of Salerno. Demographic characteristics, anthropometric data, and usage of immunosuppressive drugs were collected. Patients underwent a physical examination, and laboratory tests, including C-reactive protein (CRP) and fecal calprotectin (FC). A standardized questionnaire was used to assess gastrointestinal (GI) symptoms such as abdominal pain and fecal incontinence. For the latter, we also used the Wexner score. Crohn's Disease Activity Index (CDAI) and Mayo score as well as FC levels, and endoscopic findings were used to classify IBD patients as in active or in remission phase. Patients with perianal manifestations were excluded. Hormonal values (FSH, LH, Prolactin, 17-betaestradiol, testosterone) were measured. Sexual function was evaluated using the International Index of Erectile Function (IIEF), Male Sexual Health Questionnaire (MSHQ), Ejaculatory Dysfuction (EjD), prostatic dysfunction using the National Institute of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) and International Prostatic Symptoms Score (IPSS). QoL was assessed by FiQol domains (lifestyle, coping behaviour, self‐perception and depression, embarrassment).

Results

Eighty-five male IBD patients (47 Crohn's disease [CD] and 38 ulcerative colitis [UC]), were enrolled. Mean age was 43.7 ± 15.9 years; mean BMI was 36.4±25.5 Kg/m². Twenty-four CD patients had an active disease and 23 were in remission, while 20 UC patients had an active disease and 18 were in remission. UC patients showed significantly higher fecal incontinence and Wexner scores compared to CD patients (1.0±1.9 vs 0.4±1.2, p=0.05 and 2.84±4.2 vs 2.3±1.1, p=0.01, respectively). Only the Mayo score significantly correlated with Wexner score (Rs=0.578; p<0.001), and fecal incontinence (Rs=0.584; p<0.001). Sexual function, evaluated by erectile and prostatic scores, nicely correlated each other’s (p<0.05 in all cases). However, no association was found between fecal incontinence and all sexual function scores. The FiQol domain self‐perception and depression was significantly associated with IIEF (p=0.01).

Conclusion

This study highlighted the prevalence of fecal incontinence is higher in UC than CD patients. However, fecal incontinence did not impact on sexual function, evaluated by erectile and prostatic scores. QoL influenced erectile function.

Introduction

Quality of life (QoL) measures and symptom frequency/severity are common patient-centred outcomes in clinical practice and drug trials. However, the relationship between QoL measures and symptom burden among patients with celiac disease (CeD) is poorly understood. This study evaluated QoL scores in relation to self-reported symptom severity.

Aims & Methods

The Virtual Celiac Symptoms Study (NCT05309330) is a patient survey that followed US adults (≥ 18 years) and adolescents (12–17 years) with CeD currently adhering to a gluten-free diet, for a study period of 12 weeks. Participants self-reported daily symptom severity through the Celiac Disease Symptom Diary 2.1^© (CDSD 2.1) and completed the Celiac Disease Quality of Life 20-item questionnaire (CD-QoL) covering a 30-day recall period through a web application. The CDSD 2.1 included five core CeD symptoms (abdominal pain, bloating, diarrhoea, nausea, and tiredness) scored 1 to 5 as none, mild, moderate, severe, and very severe, respectively. The CD-QoL total scores range from 20 to 100, with higher scores corresponding to better QoL. The CDSD 2.1 score was calculated as the daily average symptom severity during the 4 weeks prior to completing the CD-QoL and was categorized as increasing score quartiles; quartile 1 (Q1, reference) represented the lowest possible score and Q4 the highest possible score. In addition, individual CDSD 2.1 symptoms were categorized by severity (none/mild [reference], moderate, and severe/very severe). The mean adjusted percentage difference and 95% confidence interval (95% CI) in CD-QoL scores was estimated by generalized linear regression which included terms for age, sex, race, years since CeD diagnosis, and body mass index.

Results

At Week 7, 404 participants in total had complete information on CD-QoL and CDSD 2.1 scores. The mean (standard deviation [SD]) CD-QoL score was 56.83 (19.21) and the mean (SD) score for CDSD 2.1 was 0.72 (0.56). The CD-QoL scores had a positive linear association with CDSD 2.1 overall scores as well as with individual symptom severity scores. Participants had a 52.7% (95% CI: 39.2%, 67.4%) higher CD-QoL score when comparing those in CDSD 2.1 Q4 (median [min–max] score 1.19 [0.85–3.00]) with those in Q1 (reference; median [min–max] score 0.07 [0.00–0.19]), which was unchanged when tiredness was excluded from the CDSD 2.1 score (53.2% [95% CI: 39.9%, 67.8%]). The positive association between CD-QoL and CDSD 2.1 was mainly driven by abdominal pain, tiredness, and bloating. Comparing participants with severe/very severe symptoms with those with none/mild symptoms, the CD-QoL score was 38.8% (95% CI: 28.2%, 50.2%) higher for abdominal pain, 37.8% (95% CI: 25.5%, 51.3%) higher for tiredness, and 32.2% (95% CI: 21.7%, 43.6%) higher for bloating.

Conclusion

In patients with CeD assessed via a digital platform, those with a higher symptom severity burden, assessed with CDSD 2.1, had significantly greater (worse) CD-QoL scores, which suggests that the CDSD 2.1 might be a good indicator of clinically active disease among patients with CeD.

Disclosure

MA, NC, SG, RS, and DAL are employees and shareholders of Takeda. LMM was an employee of Takeda at the time of the study. JRM and ES are employees of Analysis Group, Inc., which received research support from Takeda Development Center Americas, Inc. DA has served as a consultant for Takeda Pharmaceuticals and Ironwood Pharmaceuticals. MG is an employee of the Celiac Disease Foundation, which received financial support from Takeda Development Center Americas, Inc. EL serves as a consultant for Takeda Pharmaceuticals and is an author for UpToDate (celiac section) for which he receives royalties.