Inflammatory Bowel DiseasesFLOWERNCT06616714
Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease
An observational study of Inflammatory Bowel Diseases and Obesity, run by Laterza Lucrezia at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Obesity
- What is being tested?
- Observtional Study
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 20 May 2024to 20 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IBD in remission and obesity
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Lucrezia Laterza
Roma, 00168
Elisa Foscarini, SC, +390630156876, elisa.foscarini@guest.policlinicogemelli.it
Francesca Profeta, SC, +390630156876, francesca.profeta@guest.policlinicogemelli.it
About this study
Official title: Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and inflammatoRy Bowel Disease
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.
Read the detailed description
This is a single center, observational, prospective clinical study. ESG is a procedure commonly performed in our center thus only patients who have indication to ESG for clinical reasons will be included and ESG will be performed as per clinical practice. Follow-up of the enrolled patients will be planned according to the routine follow-up for patients with IBD regarding timing and laboratory procedures.
All participants will undergo a lifestyle modification treatment, nutritional and psychological support as per clinical standard of practice. Investigators and study personnel from the study site will ensure that equal instructions for diet, physical activity, laboratory analysis and other procedures will be used for each patient. All patients will also perform ESG within 90 days after the enrollment and they will be followed-up for 12 months after ESG. Patients will be evaluated before, immediately after and at 1, 3, 6 and 12 months after ESG.
The total duration of this study will be about 27 months. It will take place at Fondazione Policlinico Universitario A. Gemelli IRCCS, CEMAD unit and Digestive Endoscopy unit.
- Conditions
- Inflammatory Bowel Diseases, Obesity
- Being tested
- Observtional Study
- Medical subject headings
- Inflammatory Bowel Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observtional StudyOther
Observtional Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Assessment Based on Completion Rate of ESG Procedure Without Complications
Feasibility will be expressed as the percentage of patients who will complete the ESG procedure without intra-procedural and post-procedural (within 48 hours) complications.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start20 May 2024
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laterza Lucrezia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laterza Lucrezia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Lucrezia Laterza, PI, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616714
- Sponsor's protocol ID
- 6359
- Acronym
- FLOWER
- Status last verified
- Sep 2024
- First submitted
- 16 Feb 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and inflammatoRy Bowel Disease
- ClinicalTrials.gov ID
- NCT06616714
- Acronym / sponsor ID
- FLOWER / 6359
- Conditions
- Inflammatory Bowel Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Laterza LucreziaUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single center, observational, prospective clinical study. ESG is a procedure commonly performed in our center thus only patients who have indication to ESG for clinical reasons will be included and ESG will be performed as per clinical practice. Follow-up of the enrolled patients will be planned according to the routine follow-up for patients with IBD regarding timing and laboratory procedures.
All participants will undergo a lifestyle modification treatment, nutritional and psychological support as per clinical standard of practice. Investigators and study personnel from the study site will ensure that equal instructions for diet, physical activity, laboratory analysis and other procedures will be used for each patient. All patients will also perform ESG within 90 days after the enrollment and they will be followed-up for 12 months after ESG. Patients will be evaluated before, immediately after and at 1, 3, 6 and 12 months after ESG.
The total duration of this study will be about 27 months. It will take place at Fondazione Policlinico Universitario A. Gemelli IRCCS, CEMAD unit and Digestive Endoscopy unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IBD in remission and obesity
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observtional StudyObservtional Study | Other | – |
Primary outcome
Feasibility Assessment Based on Completion Rate of ESG Procedure Without Complications
Time frame: 24 month
Feasibility will be expressed as the percentage of patients who will complete the ESG procedure without intra-procedural and post-procedural (within 48 hours) complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucrezia Laterza, PI principal investigator
Fondazione Policlinico A. Gemelli IRCCS, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Obesity, run by Laterza Lucrezia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucrezia Laterza, PI (+390630156876, lucrezia.laterza@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Assessment Based on Completion Rate of ESG Procedure Without Complications (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.