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

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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035927

Enrollment

Registered

2021-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Oral Prebiotic Supplementation: administration of 10 grams of fructose oligosaccharide dissolved in water daily after dinner from Day -30 until day 90 post transplant Control Interventi

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To compare the incidence of grade II-IV acute GVHDTimepoint: 100 days	—

Secondary

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

Countries

India

Contacts

Public ContactLekshmon KS

PGIMER

lad.deepesh@pgimer.edu.in94177701112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026