Nutritional Support With TGF-β2 Food for Special Medical Purposes (TGF-β2 FSMP) in Adult Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) for the Prevention of Malnutrition: a Prospective, Randomized, Multicenter Study
Launched by AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA · Jun 4, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a special nutritional supplement called TGF-β2 food for patients who are undergoing a type of treatment known as allogeneic stem cell transplantation (allo-HSCT). The main goal of the study is to see if this supplement can help prevent malnutrition in these patients compared to the best supportive care currently available. Additionally, the researchers will also check if the supplement can reduce the chances of a severe complication called acute graft-versus-host disease (GVHD) within the first 100 days after the transplant.
To be eligible for this trial, participants need to have a proper working digestive system and expect to live for more than 12 weeks. They must also be scheduled to receive an allogeneic stem cell transplant and agree to participate by signing a consent form. However, people with certain medical conditions, such as active blood cancers or previous bowel surgeries, cannot join the study. If you or a loved one are interested in this trial, it could offer a chance to receive additional nutritional support during a challenging time.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Intact intestinal tract
- • Life expectancy more than 12 weeks
- • Allogeneic stem cell transplantation
- • Signed informed consent
- Exclusion Criteria:
- • Active hematological disease at the beginning of conditioning
- • Personal history of inflammatory bowel diseases
- • Personal history of bowel resection
- • Personal history of gastric bypass procedures
- • Enrolment in a competitive prospective study (malnutrition or GVHD as primary outcome)
- • Subjects with known hypersensitivity to milk proteins or components of Modulen-IBD
About Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
The Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is a leading healthcare organization based in Brescia, Italy, dedicated to providing high-quality medical services and promoting clinical research. As a prominent clinical trial sponsor, it focuses on advancing medical knowledge and improving patient care through innovative research initiatives. The institution integrates multidisciplinary expertise and state-of-the-art facilities to facilitate the development of new therapies and treatments, ensuring adherence to rigorous ethical and regulatory standards. With a commitment to enhancing public health, the Azienda plays a pivotal role in fostering collaborations among healthcare professionals, researchers, and industry partners.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Enrico Morello, MD, PhD
Principal Investigator
Asst Degli Spedali Civili Di Brescia
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported