Clinical Observation on the Efficacy of Patient-Donor Derived Probiotics in Improving Intestinal Flora Disorder in Patients With Intestinal Acute Graft-Versus-Host Disease (aGVHD)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >50 years, regardless of gender;

Scheduled for haploidentical hematopoietic stem cell transplantation;

ECOG performance status score ≤2;

Voluntarily participate and provide written informed consent.

Disqualifiers

Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);

Clostridioides difficile infection (CDI): Recurrent or refractory CDI;

Other conditions: Ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS), diarrhea associated with dysbiosis, liver cirrhosis;

Antibiotic usage within 7 days prior to enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Patient-Donor Derived Probiotics

    Drug

    To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Patient-Donor Derived ProbioticsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical response rate of intestinal acute graft-versus-host disease (aGVHD)

Changes of stool frequency of subjects before and after taking probiotic capsules from patients.

Time frame
within 100 days

Secondary outcomes

1

To study the changes of intestinal flora of subjects before and after taking probiotics from patients for 100 days

16SrDNA intestinal flora detection, to study the changes of Bifidobacterium, Lactobacillus and Clostridium before and after taking probiotics from patients for 100 days.

Time frame
within 100 days

Other outcomes

Sponsors and contacts

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