NCT06126432

Brief Summary

To determine whether probiotics have beneficial effect on gut dysbiosis and postoperative ascending cholangitis in patients with pancreaticoduodenectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3.8 years

First QC Date

November 6, 2023

Last Update Submit

November 6, 2023

Conditions

Precancerous Lesions

Keywords

AmpullaryPancreas

Outcome Measures

Primary Outcomes (1)

  • The effects of probiotics on the postoperative ascending cholangitis

    To determine the gut microbiota in control of ascending cholangitis before and after pancreaticoduodenectomy through the analysis of microbial community by next generation sequencing.

    12 weeks

Study Arms (1)

To evaluate the effects of probiotics consumption

EXPERIMENTAL

Subjects consumed 2 bottles of probiotics-containing yogurt per day for 1 month

Dietary Supplement: Yugart

Interventions

YugartDIETARY_SUPPLEMENT

Yugart 2 bottles per day for 1 month

To evaluate the effects of probiotics consumption

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with peri-ampullary lesions and scheduled to receive pancreaticoduodenectomy (PD) were designed as experimental group; subjects with pancreatic lesions and scheduled to receive distal pancreatectomy (DP) were designed as control group.
  • Subjects that already received PD for more than 6 months to join the study and aim to evaluate the effect of probiotics on gut microbiota and postoperative ascending cholangitis (POAC).
  • Subjects with the amount of two bottles a day (one provided in the morning and the other in the afternoon) for a duration of 4 weeks.

You may not qualify if:

  • Subjects are currently participating in any other clinical trials or studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single intervention arm with trial treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 13, 2023

Study Start

March 30, 2015

Primary Completion

December 31, 2018

Study Completion

July 31, 2019

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)