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The effects of synbiotics on the gut microbiota in patients with cancer therapy

The effects of synbiotic 1-kestose and Bifidobacterium longum on the gut microbiota in patients with cancer therapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041210128
Enrollment
200
Registered
2022-01-18
Start date
2022-01-18
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

cancer patients

Interventions

Assign patients to either kestose plus B. longum (synbiotics) administration group or non-administration group.

Sponsors

Hirooka Yoshiki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have received sufficient explanation before participating in this study, and have obtained written consent by their own free will with sufficient understanding. 2. Patients aged 20 at the time of consent. 3. Patients who have been receiving chemotherapy.

Exclusion criteria

Exclusion criteria: Patients who are judged to be inappropriate by the investigator and the investigator.

Design outcomes

Primary

MeasureTime frame
Evaluation of the intestinal microbiota and the Bristol stool scale

Secondary

MeasureTime frame
: Determining overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) according to Response Evaluation Criteria (RECIST 1.1). : Improvement of nutrition state (body weight, muscle mass, body cell mass, phase angle, serum albumin) : Evaluating nutrition state using Visual Analogue Scale (VAS) : Assessing performance status : Evaluating adverse events using CTCAE v5.0 : Characterizing overall survival (OS) : Assessing Liver function Child-Pugh (CP) score and the Albumin-Bilirubin (ALBI) Grade

Contacts

Public ContactKohei Funasaka

Fujita Health University Hospital

k-funa@fujita-hu.ac.jp+81-562-93-2688

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026