Meteor study

JRCT ID: jRCTs031220740

Registered date:01/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic constipation
• Date of first enrollment: 15/07/2023
• Target sample size: 35
• Study type: Interventional
• Intervention(s): In this study, the first 14 days after enrollment will be used as the baseline period to keep a defecation diary. On the 15th day after enrollment, patients will start oral administration of BIOFERMIN Tablets. Two Biofermin tablets will be orally administered three times a day after each meal for 8 consecutive weeks.

Outcome(s)

• Primary Outcome: Change in butyric acid in stool at enrollment and at week 8 (Day 56) after treatment initiation

Secondary Outcome

- Organic acids in stool (formic acid, acetic acid, propionic acid, valeric acid, succinic acid, lactic acid)
- Serotonin and dopamine in blood
- Bile acids in blood and stool
- Shotgun metagenomic analysis of the intestinal microbiota
- fecal metabolite
- Days of bowel movements, bowel movements, Stool form, Straining, Sense of incomplete evacuation
- Number of rescue use
- Japanese version of the Patient Assessment of Constipation Quality of Life

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1) Patients diagnosed with chronic constipation by ROME IV or previously diagnosed with chronic constipation by ROME IV and under treatment
2) Men and women between the ages of 18 and 85 at the time consent is obtained
3) Patients who can provide written consent for participation in this study from the subject him/herself
4) Patients with a JPAC-QOL overall score of 1 or higher

Exclude criteria

1) Patients with or suspected of having abnormal rectoanal function
2) Patients with organic abnormalities that cause constipation noted on colonoscopy within 5 years
3) Patients with serious complications (liver disease: Child-Pugh classification C or higher, renal disease: CKD stage 4 or higher, cardiac disease: NYHA classification III or higher, metabolic disease: HbA1c 10% or higher, malignant tumor diagnosed within the past 5 years [Excluded if fully cured], etc.)
4) Patients with pre-existing or complicated celiac disease or inflammatory bowel disease
5) Patients with serious psychiatric complications
6) Patients with alcohol and drug abuse
7) Patients with a history of allergy to the study drug
8) Patients newly treated for constipation within 2 weeks prior to enrollment
9) Patients whose dosage and administration of ongoing medications for constipation was adjusted within 2 weeks prior to enrollment
10) Patients taking probiotics other than protocol therapy (e.g.over-the-counter intestinal medications, etc.)
11) Patients newly treated with opioids or sleeping pills within 2 weeks prior to enrollment
12) Patients entering a clinical study with intervention within 4 weeks
13) Patients with pre-existing or complicated Parkinson's disease
14) Patients deemed inappropriate by a physician

Related Information

• Primary Sponsor: Kobayashi Takashi
• Source(s) of Monetary Support: Biofermin Pharmaceutical Co., Ltd.