Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease

Launched by LATERZA LUCREZIA · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called endoscopic sleeve gastroplasty (ESG) to see if it is safe and effective for people with obesity who also have inflammatory bowel disease (IBD). Obesity, which is when a person's body mass index (BMI) is over 30, can worsen IBD and lead to other health problems. The trial aims to help patients lose weight and improve their overall health, especially since obesity can make IBD harder to manage.

To be eligible for this study, participants must be between 18 and 70 years old, have a BMI between 30 and 40, and have been in stable remission from IBD for at least six months without using steroids. They should also be on stable medication for IBD. Participants can expect to receive the ESG procedure and will be monitored closely throughout the study. It's important for potential participants to know that those with certain health issues or active IBD symptoms will not be able to join, as the trial is focused on evaluating the procedure's safety in a specific group of patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 to 70 years
• • BMI between 30 to 40 kg/m2
• • Willingness to participate in the study and ability to comply and understand the study protocol
• • Patients with steroid-free clinical remission of IBD for at least 6 months before screening as defined by HBI ≤4 for patients with Crohn's disease OR by partial Mayo score (3-point Mayo score) ≤1 with rectal bleeding subscore =0 for patients with ulcerative colitis AND no use of systemic steroids during the 6 months before screening
• • Patients with a previous diagnosis of Crohn's disease or Ulcerative colitis at least 3 months before screening
• • Patients with stable maintenance therapy for IBD, meaning a stable dose of mesalamine, immunosuppressants of biological drugs for at least 8 weeks before ESG (baseline).
• Exclusion Criteria:
• • Active Helicobacter pylori infection, causing erosions or ulcers of the stomach or duodenum.
• • Organic or motility disorder of the stomach and / or esophagus
• • Previous bariatric surgery or any other type of surgery that causes alteration of the lumen of the esophagus, stomach and duodenum
• • Ongoing or active malignancy during the last 5 years.
• • Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
• • Drug or alcohol abuse
• • Bulimic or binge eating pattern
• • Uncontrolled thyroid disease
• • Pregnancy, breastfeeding
• • Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
• • Liver cirrhosis of any Child-Pugh stage or MELD\> 15 Chronic Severe Renal Insufficiency (eGFR \< 30 ml/min/1.73 m2 based on CKD-EPI equation)
• • Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
• • Active IBD as defined by HBI \>4 for patients with Crohn's disease OR by partial Mayo score \>1 with rectal bleeding subscore ≥1 for patients with ulcerative colitis OR by the concomitant use of systemic steroids to control disease activity in both Crohn's disease and ulcerative colitis
• • Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.