Actively Recruiting
Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease
Led by Laterza Lucrezia · Updated on 2024-10-01
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obesity is classified as a body mass index (BMI) above 30 kg/m2 by the World Health Organization. Both overweight (BMI \> 25 kg/m2) and obesity (BMI \>30 kg/m2) have increased worldwide during the last decades: 1.46 billion of the adult population were estimated to be overweight in 2008, particularly 205 million men and 297 millions of women were estimated to be obese. Obesity is associated with lower quality of life and is linked to serious comorbidities such as type 2 diabetes mellitus, hypertension, cardiovascular diseases and several cancers. Furthermore, obesity is significantly linked to a higher mortality risk compared to normal weight individuals. Obesity is also significantly increasing in patients with IBD. Obesity enhances the inflammatory activity in IBD, leads to longer hospitalization, and increases the possibility to develop extra intestinal manifestations. Also, the frequency of having extended systemic steroid treatment and use of antibiotics seems greater in IBD patients with obesity. Hence, treatment and prevention of obesity, especially in IBD patients, should have high priority.
CONDITIONS
Official Title
Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Body mass index (BMI) between 30 to 40 kg/m2
- Willingness and ability to participate and understand the study
- Steroid-free clinical remission of IBD for at least 6 months before screening (HBI for Crohn's disease or partial Mayo score with rectal bleeding subscore =0 for ulcerative colitis)
- Diagnosis of Crohn's disease or ulcerative colitis at least 3 months before screening
- Stable maintenance therapy for IBD with mesalamine, immunosuppressants, or biological drugs for at least 8 weeks before ESG
You will not qualify if you...
- Active Helicobacter pylori infection causing stomach or duodenal erosions or ulcers
- Organic or motility disorder of the stomach or esophagus
- Previous bariatric surgery or surgery altering the esophagus, stomach, or duodenum
- Ongoing or active cancer within the last 5 years
- Heart attack in past 6 months or severe heart failure (class III or IV)
- Drug or alcohol abuse
- Bulimic or binge eating patterns
- Uncontrolled thyroid disease
- Pregnancy or breastfeeding
- Psychiatric or cooperation problems preventing study participation
- Liver cirrhosis or severe kidney failure
- Participation in another experimental drug study within 30 days or five drug half-lives
- Active IBD with higher disease activity or recent steroid use
- Any health condition judged by the investigator to pose risk during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lucrezia Laterza
Roma, Italy, 00168
Actively Recruiting
Research Team
L
Lucrezia Laterza, PI
CONTACT
E
Elisa Foscarini, SC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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