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A prospective randomized controlled clinical trial of Lactobacillus to reduce the incidence of severe acute graft versus host disease after unrelated umbilical cord blood transplantation

A prospective randomized controlled clinical trial of Lactobacillus to reduce the incidence of severe acute graft versus host disease after unrelated umbilical cord blood transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015902
Enrollment
Unknown
Registered
2018-04-27
Start date
2018-07-20
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

hematologic malignancies after umbilical cord blood transplantation

Interventions

Probiotics Treatment Group:From pretreatment to 30d daily intake of a quantitative probiotics components, adults 2 times a day, 10g
children 2 times a day, once 5g, 40 degree C, the following warm boiling water blunt (taboo and antibiotics taken at the same time)
Blank control Group:No Probiotics component

Sponsors

Anhui Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clearly diagnosed patients with malignant hematological diseases any weight, age, and race; 2. Patients and their families voluntarily carry out unrelated umbilical blood transplantation (UCBT) and sign informed consent; 3. Patients and their families volunteered to participate in this study and sign informed consent; 4. Each participant must sign an informed consent (ICF) to indicate that he/she understands the purpose and procedure of the study and is willing to participate in the study; from the patient's condition, if the patient's signature is not conducive to the treatment of the illness, the legal representative will sign ICF.

Exclusion criteria

Exclusion criteria: 1. Patients with serious disorders of organ dysfunction or disease, such as heart, liver, kidney and pancreas, and other serious diseases and dysfunction; 2. Those who cannot tolerate oral probiotics components; 3. Participants and/or authorized family members refused to UCBT and probiotic components; 4. Three months to participate in other similar clinical studies; 5. The researchers found that the group was not suitable (for example, patients who were expected to be unable to adhere to the treatment due to funding problems).

Design outcomes

Primary

MeasureTime frame
The incidence of severe acute graft-versus-host disease (aGVHD);

Secondary

MeasureTime frame
The incidence of pre-engraftment syndrome;The incidence and time of neutrophil implantation;The incidence and time of platelet implantation;Immune function reconstruction;The incidence of infection;180d transplant related mortality;Sequencing of fecal bacteria group;

Countries

China

Contacts

Public ContactHui-Lan Liu

Department of Hematology, Anhui Provincial Hospital, Anhui Provincial Hospital

13866771269@163.com+86 13866771269

Outcome results

None listed

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