SYNbiotics Effect Research after sleeve Gastrectomy In Severely obese patients on intestinal flora: a double blind, randoMized controlled trial

Not Applicable

Recruiting

• Conditions: severe obesity

• Registration Number: JPRN-jRCTs031210451
• Lead Sponsor: Kusumoto Tetsuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients who meet all of the following criteria are included in this study:
1. patients with severe obesity (whose BMI is 35 kg/m2 or more at the first visit)
2. patients with obesity-related complication (type 2 diabetes mellitus, hypertension, dyslipidemia, or sleep apnea syndrome)
3. patients who are planned to take laparoscopic sleeve gastrectomy due to the severe obesity in the medical institutions that conduct this study
4. patients who are aged of 20 years or older and 65 years or younger at giving their consent
5. patients who provide their consent in a written form by themselves after full explanation of this study

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study:
1. patients with history of allergy against bifidobacteria, lactic acid bacteria, or galacto-oligosaccharide
2. patients who take supplements including prebiotics and probiotics other than the study food in this study
3. patients who take supplements or medical agents that consist with bifidobacteria, lactic acid bacteria, or galacto-oligosaccharide routinely, or patients who take yogurt (that includes lactic acid bacteria or Lactobacillus delbrueckii subsp. bulgaricus) or lactic acid bacteria beverage routinely for the purpose of intestinal regulation
4. patients with dementia
5. patients with alcoholism at giving their consent
6. patients who need legal representative for giving consent
7. patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified