Mucositis is one of the most common problem in patients who are undergoing stem cell transplant receiving high dose chemotherapy in patients undergoing hematopoietic stem cell transplantation.

â??A pilot study of efficacy of Lactobacillus CD2 lozenges in preventing high-dose chemotherapy induced oral mucositis in patients undergoing hematopoietic stem cell transplantationâ??

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002140

Enrollment

Registered

2011-11-17

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 hematopoetic stem cell transplant

Interventions

Intervention1: Lactobacillus CD2 logenzes: The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient Intervention2: lactobacillus: The study drug c

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
1. Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantationTimepoint: daily assessment of mucositis till resolution or till 24 days. whichever is earlier.	—

Secondary

Measure	Time frame
2. Determine the incidence of Grade I and II mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation (Criteria for assessment is given in Appendix 1). 3. Duration of and time period for healing of chemotherapy induced oral mucositis. 4. Determine incidence and severity of dysphagia Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.	—

Measure

Time frame

2. Determine the incidence of Grade I and II mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation (Criteria for assessment is given in Appendix 1). 3. Duration of and time period for healing of chemotherapy induced oral mucositis. 4. Determine incidence and severity of dysphagia Timepoint: daily assessment of mucostits till resolution or day 24 of the treatment.

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Countries

India

Contacts

Public ContactDr Atul sharma

atul1@hotmail.com01126589490

Outcome results

None listed

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