IBD (general)Recruiting
Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease
Observational · No treatment assigned · 1 site · Laterza Lucrezia
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases and Obesity. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 3 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2024-05-20.
- Main results expected around 2026-05-20 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Feasibility Assessment Based on Completion Rate of ESG Procedure Without Complications (24 month)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Obesity |
| Lead sponsor | Laterza Lucrezia |
| Enrollment | 20 (estimated) |
| Start date | 2024-05-20 |
| Primary completion (est.) | 2026-05-20 |
| First posted | 2024-09-27 |
| Last updated | 2024-10-01 |
| Official title | Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and inflammatoRy Bowel Disease |
| ClinicalTrials.gov ID | NCT06616714 |
Interventions
- Observtional Study (Other)
Observtional Study
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Lucrezia Laterza | Roma | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.