Big STAR study

JRCT ID: jRCTs051190109

Registered date:19/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastrointestinal symptoms
• Date of first enrollment: 08/04/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Study subjects take the study agent for 10 weeks (plus/minus 2 weeks)

Outcome(s)

• Primary Outcome: Change in GSRS score from baseline to week 10

Secondary Outcome

1. Change and percent change in following parameters from baseline to week 12
- GSRS score
- fecal properties / Bristol Scale score
- HbA1c
- Glycoalbumin
- fasting plasma glucose
- C-peptide
- active GLP-1
- total bile acid
- gut microbiota (type of enterobacteria, relative abundance, alpha diversity, and beta diversity)
2. Change in GSRS score from baseline to week 10 stratified by following factors
- age
- gender
- BMI
- type of gastrointestinal symptoms
- administrating drugs
3. Correlations between change in fecal properties and change in biomarkers above

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria are included in this study:
1.Patients with gastrointestinal symptoms such as diarrhea or constipation
2.Patients whose mean Gastrointestinal Symptom Rating Scale (GSRS) subdomain score (diarrhea, constipation) is three or higher
3.Patients who are diagnosed with type 2 diabetes mellitus without neuropathy
4.Patients who use metformin and who do not use four or more antidiabetic agents
5.Patients who do not use new antibiotics within 12 weeks before giving their consent
6.Patients who are not treated with new interventions for diet therapy within 12 weeks before giving their consent
7.Patients who do not change concomitant drugs (addition or withdrawal of the concomitant drugs or change of usage or dose of the concomitant drugs) within 12 weeks before giving their consent
8.Male and female aged 20 years or older, and 75 years or younger when giving their consent
9.Patients who give their consent in a written form

Exclude criteria

Patients who fall into any of the following criteria are excluded from participating in the study:
1.Patients whose mean weekly defecation is less than once, or 42 times or more within 1 month before giving their consent
2.Patients who are diagnosed to have structural diseases by colonoscopy within 5 years before giving their consent
3.Patients with history or combination of celiac disease or inflammatory bowel disease
4.Patients with HbA1c of 9% or higher at giving their consent
5.Patients who are suffered by myocardial infarction, cerebral infarction, or stroke within 12 weeks before giving their consent
6.Patients with severe hepatic dysfunction (AST or ALT is 5 times or more higher than upper limit in the collaborative research institutions
7.Patients with severe renal dysfunction (eGFR is less than 30 ml/min/1.73 square meter)
8.Patients with malignant neoplasm
9.Patients with history of allergy against bifidobacteria
10.Patients who use any other drugs or supplements which affect the functions of the inestines
11.Patients who use GLP-1 receptor antagonists or drugs which have high possibility to cause gastrointestinal symptoms (prokinetic agents, gastrointestinal dysfunction therapeutic agents, antiemetic agents, or anticholinergic agents, etc.)
12.Patients who routinely take foods, supplements or pharmaceutical agents including bifidobacteria (such as yogurt or chocolates)
13.Patients with other conditions that the investigator or researcher thinks inappropriate for the study

Related Information

• Primary Sponsor: Fukui Michiaki
• Source(s) of Monetary Support: Biofermin Seiyaku Co., Ltd.