The effects of synbiotics on the improvement of intestinal microenvironment: A randomized controlled study

JRCT ID: jRCTs041190128

Registered date:13/03/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who are going to undergo highly invasive abdominal surgery listed above.
• Date of first enrollment: 13/03/2020
• Target sample size: 105
• Study type: Interventional

Intervention(s)

Drug: Super Synbiotics LBG-P (a supplement for medical use), which contains Lactobacillus casei Shirota (100-1000 million) and Bifidobacterium breve Yakult (100-1000 million) per one packet as probiotics and galactooligosaccharide (6.8g) per one packet as prebiotics.
1) Probiotics group: intake three packets of probiotics per day for 2 weeks.
2) Prebiotics group: intake three packets of prebiotics per day for 2 weeks.
3) Synbiotics group: intake three packets of probiotics and prebiotics per day for 2 weeks.

Outcome(s)

• Primary Outcome: Compare the relative changes of intestinal micribiota profile, fecal organic acid concentrations, and pH before and after the intake of probiotics, prebiotics, and synbiotics.
• Secondary Outcome: Compare the intestinal microbiota profile, fecal organic acid concentrations, and pH after two weeks intake of probiotics, prebiotics, and synbiotics.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who are going to undergo highly invasive abdominal surgery in Nagoya University Hospital.
Highly invasive surgeries in this study include followings:
Major hepatectomy
Hepatopancreatoduodenectomy
Pancreatoduodenectomy
Distal pancreatectomy with celiac axis resection
Subtotal esophagectomy
Other surgeris that are considered as highly invasive by primary investigator
Target diseases: every diseases that require highly invasive surgery (irrespective of malignancy)
Patients with the age equal to or more than 20

Exclude criteria

Patients who reject participation for this study
Patients wiht severe cognitive disease
Other patients who are considered not eligible for this study (by the decision of investigators)

Related Information

• Primary Sponsor: Yokoyama Yukihiro