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

JRCT ID: jRCTs031210451

Registered date:26/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: severe obesity
• Date of first enrollment: 11/01/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Patients who are planned to take laparoscopic sleeve gastrectomy due to the severe obesity in the medical institutions that conduct this study are randomly assigned into symbiotics group and placebo group, and intake the symbiotics or placebo 3 times/day after the laparoscopic sleeve gastrectomy.

Symbiotics group:
Intake symbiotics (Synprotec, Yakult Honsha Co., Ltd.) including 1 package of living bifidobacteria and lactic acid bacteria-containing food (1.0 g/time) and 1 package of oligosaccharide-containing food (6.8 g/time) 3 times/day at the time of every meal for 12 months

Placebo group:
Intake two types of placebo (1.0 g/time and 6.8 g/time) 3 times/day at the time of every meal for 12 months

Outcome(s)

• Primary Outcome: Change in total number of fecal bacteria from baseline (before the laparoscopic sleeve gastrectomy to week 52 (52 weeks after the laparoscopic sleeve gastrectomy)

Secondary Outcome

1. measurements of total number of fecal bacteria at baseline, week 4, 12, 26, and 52, and change in the total number of fecal bacteria from baseline to week 4, 12, and 26
2. composition of fecal microbiota at baseline, week 4, 12, 26, and 52, and change in the composition of fecal microbiota from baseline to week 4, 12, 26, and 52
3. number and detection rate of major bacteria in the intestinal microflora at baseline, week 4, 12, 26, and 52, and change in the number of the major bacteria in the intestinal microflora from baseline to week 4, 12, 26, and 52
4. number of genus and species and detection rate of oral bacteria in feces at baseline, week 4, 12, 26, and 52, and change in number of genus and species of oral bacteria in feces from baseline to week 4, 12, 26, and 52
5. concentration of organic acid in blood at baseline, week 4, 12, 26, and 52, and change in concentration of organic acid in blood from baseline to week 4, 12, 26, and 52
6. concentration of organic acid and bile acid in feces at baseline, week 4, 12, 26, and 52, and change in concentration of organic acid and bile acid in feces from baseline to week 4, 12, 26, and 52
7. composition of salivary microbiota and number of genus and species and detection rate of oral bacteria in saliva at baseline, week 4, 12, 26, and 52, and change in the composition of salivary microbiota and number of genus and species and detection rate of oral bacteria in saliva from baseline to week 4, 12, 26, and 52
8. change in body weight from baseline to week 4, 12, 26, and 52
9. proportion of patients who achieve amelioration of obesity-related complication (type 2 diabetes mellitus, hypertension, dyslipidemia, or sleep apnea syndrome) from baseline til week 4, 12, 26, and 52
10. change in blood glucose-related biomarkers, lipid biomarkers, hepatic function biomarkers, hemocytometric tests, and hs-CRP from baseline to week 4, 12, 26, and 52
11. change in daily energy and nutrients intake measured by BDHQ before the laparoscopic sleeve gastrectomy to week 52

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kusumoto Tetsuya
• Secondary Sponsor: Soiken Inc.