constipation constipation, irritable bowel syndrome with constipation
Conditions
Interventions
consume psyllium approximately 6.6g/day or natto 2 packs /day for 4 weeks
D011620, D045730
psyllium, natto
Sponsors
Sawada Akinari
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who meet the Rome IV criteria for functional constipation or constipation-predominant irritable bowel syndrome (IBS-C) 2. Patients who have complete spontaneous bowel movement without the need for laxatives three times or fewer per week 3. Patients aged from 18 years to 70 years at the time of obtaining consent 4. Patients who have received sufficient explanation about this study, fully understood it, and provided written informed consent voluntarily 5. Patients who are able to participate in this study according to the research protocol
Exclusion criteria
Exclusion criteria: 1. Patients who habitually consume natto, psyllium, fermented foods, or probiotics 2. Patients with severe abdominal pain 3. Patients with warning symptoms (e.g., bloody stools, weight loss, fever) 4. Patients with active anal fistulas 5. Patients with serious comorbidities (e.g., malignancies, severe liver, heart, or renal failure, or inflammatory bowel disease) 6. Patients with severe gastrointestinal motility disorders such as chronic intestinal pseudo-obstruction or scleroderma 7. Patients with a history of gastrointestinal surgery involving bowel resection (excluding appendectomy or cholecystectomy) 8. Patients with neurological disorders (e.g., dementia, Parkinson disease, stroke) 9. Patients with psychiatric disorders 10. Patients with poorly controlled diabetes 11. Patients currently taking warfarin 12. Patients with allergies to natto or psyllium 13. Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the number of the complete spontaneous bowel movement | — |
Secondary
| Measure | Time frame |
|---|---|
| A two-group comparison will be conducted between the natto group and the psyllium group for the following items Changes in the number of complete spontaneous bowel movements and total bowel movements associated with food intake Changes in abdominal symptoms assessed by the Gastrointestinal Symptom Rating Scale and symptom diaries (Bristol Stool Form Scale, abdominal pain, abdominal discomfort, abdominal bloating, urgency of defecation, degree of straining during defecation (NRS 0-10), and sensation of incomplete evacuation (present or absent)) associated with food intake Changes in abdominal symptoms associated with food intake Satisfaction with constipation treatment associated with food intake Frequency of rescue medication use during the study period Changes in SF-8 scores associated with food intake Predictive factors for achieving the primary endpoint associated with food intake Analysis of the gut microbiota using fecal samples Associations between the gut microbiota and abdominal symptoms | — |
Contacts
Public ContactAkinari Sawada
Osaka Metropolitan University Hospital
Outcome results
None listed