Mucositis is one of the most common problem in patients who are undergoing stem cell transplant receiving high dose chemotherapy.Lactobacillus cd2(probiotics is being investigated)in this study in the prevention of mucositis(oral ulcers).

A Randomized Double Blind Placebo Controlled Phase III Study of Efficacy of Lactobacillus CD2 lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantationâ??

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003393

Enrollment

108

Registered

2013-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Prevention of mucositis in the group of patients undergoing myeloablative hematopoetic stem cell transplant

Interventions

Intervention1: Lactobacillus CD2 lozenges: It contains not less than 2x109 viable cells of Lactobacillus CD2 as active ingredient. Control Intervention1: placebo: Placebo contains a mix of fillers (li

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 10 and 70 years. 2. Karnofsky Performance Score >= 70%. 3. Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is as approved modality of therapy. 4. Patients eligible to receive high-dose chemotherapy as part of conditioning regime. 5. Concomitant co morbid condition if present, controlled by medicines. 6. Serum creatinine ï?¼ 1.8mg/dl. 7. Total bilirubin ï?¼ 2mg/dl. 8. Liver enzymes within three times of normal limit. 9. Expected survival > 6 months

Exclusion criteria

Exclusion criteria: 1. Pregnant women and lactating mothers. 2. Patients with history of AIDS 3. Patients who have taken any other investigational product in last 4 weeks. 4. Patients having untreated symptomatic dental infection. 5. Patients with WHO Grade 3 or 4 oral Mucositis. 6. Other serious concurrent illness. 7. Inconclusive histological diagnosis. 8. Patients on anticancer antibiotics. 9. Patients with signs and symptoms of systemic infections. 10. Patientâ??s/guardianâ??s refusal to sign informed consent.

Design outcomes

Primary

Measure	Time frame
Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups.Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.	—

Secondary

Measure	Time frame
1. Determine the incidence of Grade I and II mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups . 2. Duration of and time period for healing of chemotherapy induced oral mucositis. 3. Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.	—

Measure

Time frame

1. Determine the incidence of Grade I and II mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups . 2. Duration of and time period for healing of chemotherapy induced oral mucositis. 3. Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.

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Countries

India

Contacts

Public ContactDr Atul sharma

All India Institute of Medical Sciences

atul1@hotmail.com919818548149

Outcome results

None listed

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