BridgeMD
New treatment option for Ulcerative Colitis (Disorder)
Official title Partial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA
ClinicalTrials.gov ID: NCT07433946
What this study is testing
- What it's testing
- This is a multicenter, open-label, randomized two-arm interventional nutritional study evaluating the effects of partial enteral nutrition (LH VIOLA) in patients with Inflammatory Bowel Disease (IBD) at risk of malnutrition. A total of 146 patients (73 per arm) will be enrolled across 4 centers.
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18-65 years
- Diagnosis of Crohn's Disease or Ulcerative Colitis
- At risk of malnutrition according to the Malnutrition Universal Screening Tool (MUST)
- Ability to provide informed consent
- Women of childbearing potential must use effective contraception
You likely can't join if
- Following an exclusion diet (CDED)
- Current hospitalization
- Pregnancy
- Requirement for a low-protein diet
The study team makes the final eligibility decision.
Where it's taking place
- Rozzano, Milano, Italy
- Naples, Italy
- Pavia, Italy
- Roma, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rozzano, Milano, Italy; Naples, Italy; Pavia, Italy; Roma, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.