A Randomized Controlled Trial to study the efficacy of Fructo-OligoSaccharides (FOS) Peri-transplant to Restore gut microbiome and improve Outcomes in Allogeneic Hematopoietic Cell Transplantation (FOS-PRO-ACT study) - (FOS-PRO-ACT study)

Department of Internal Medicine PGIMER0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

研究概览

暂无简介。

•1.Males or females with underlying hematological diseases.
•2.Age > 12 years
•3.Undergoing Allogeneic Hematopoietic Cell Transplantation
•4.Donor of stem cells: Matched sibling, Haploidentical, and Matched unrelated donor
•5.Conditioning regimen: Myeloablative Conditioning or Reduced-Intensity conditioning
•6.Able to take oral nutrition, specifically able to swallow a suspension of 10mg/day of Fructose oligosaccharide by mouth.
•7.Study treatment both planned and able to start within 7 days of registration/randomization.
•8.Willing and able to comply with all study requirements, including consumption of dietary supplements (e.g. able to swallow suspension of FOS), timing and/or nature of required assessments (including the provision of stool samples at the predefined time points )
•9.Signed, written informed consent (main study and tissue banking).

•1.Pre-existing inflammatory gastrointestinal disease such as IBD, IBS.
•2.History of GI surgery in past involving resection of any intestinal length or creation of a blind intestinal loop.
•3.Known allergy or hypersensitivity to any prebiotic product in the past

发起方

Department of Internal Medicine PGIMER