To study the effect of FOS (nutritional supplement) in preventing post transplant complications

Phase 2

Conditions: Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue

Registration Number: CTRI/2021/08/035927

Lead Sponsor: Department of Internal Medicine PGIMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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).

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of grade II-IV acute GVHDTimepoint: 100 days

Secondary Outcome Measures

Name	Time	Method
To determine/ compare: <br/ ><br>1.Incidence of severe acute GVHD (Grade III-IV) <br/ ><br>2.Incidence of grade II-IV gut GVHD <br/ ><br>3. Incidence of CDAD <br/ ><br>4. Incidence of MDR bacteremia <br/ ><br>5. Non-relapse related mortality (NRM) <br/ ><br>6. Overall survival (OS)Timepoint: 100 days, 365 days