Not Yet RecruitingNot Applicable

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

214 participantsStarted 2025-06-01

Plain-language summary

prospective, randomized, multicenter study to confirm the potential benefits of TGF-β2 enriched FSMP. The primary objective is to evaluate the superiority of supplementing with TGF-β2 FSMP (experimental arm) compared to best supportive treatment (BST) in preventing malnutrition in patients submitted to allo-SCT. The secondary endpoints include the assessment of reduction of incidence of severe acute GVHD at day +100.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Prevention

Timeframe: given from day -7 to day +28

Trial details

NCT IDNCT07010068

SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Enrico Morello, MD, PhD

0303996811 enrico.morello@asst-spedalicivili.it

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