Endoscopic sleeve gastroplasty for obesity in patients with inflammatory bowel disease

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

This study is testing if a procedure called endoscopic sleeve gastroplasty can help people with obesity and inflammatory bowel disease improve their health and quality of life.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Roma)
• Trial ID: NCT06616714 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the feasibility and safety of endoscopic sleeve gastroplasty (ESG) in patients suffering from obesity and inflammatory bowel disease (IBD). Participants aged 18 to 70 with a BMI between 30 and 40 kg/m2 will undergo ESG as part of their clinical treatment, alongside lifestyle modifications and nutritional support. The study will follow patients for 12 months post-procedure, assessing their health outcomes and quality of life. The research will be conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS, focusing on the intersection of obesity and IBD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a BMI between 30 and 40 kg/m2 who are in steroid-free clinical remission from IBD.

Not a fit: Patients with active Helicobacter pylori infection, organic or motility disorders of the stomach, or those who have had previous bariatric surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for obese patients with inflammatory bowel disease, potentially improving their health outcomes and quality of life.

How similar studies have performed: While ESG is a common procedure, this specific application in patients with IBD is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Roma

• Lucrezia Laterza — Roma, Italy (RECRUITING)

Study contacts

• Principal investigator: Lucrezia Laterza, PI — Fondazione Policlinico A. Gemelli IRCCS, Rome
• Study coordinator: Lucrezia Laterza, PI

Conditions: Inflammatory Bowel Diseases, Obesity