Chronic constipation
Conditions
Interventions
After taking magnesium oxide preparations (330 mg/dose, 3 times a day) for 8 weeks, take magnesium oxide preparations (330 mg/dose, 3 times a day) and Biosly combination OD tablets (2 tablets/dose, 3
Sponsors
Tomita Toshihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included in the study. 1) Patients aged 18 or older and younger than 90 years. 2) Patients diagnosed with functional constipation (FC) or constipation-predominant irritable bowel syndrome (IBS-C) according to Rome IV criteria. 3) Patients with fewer than three spontaneous bowel movements (SBM) per week during the observation period. 4) Patients who understand the content of this study and have provided written consent.
Exclusion criteria
Exclusion criteria: Patients who do not fall under any of the following categories will be included in the study. 1) Patients who have taken constipation medication (prescription or over-the-counter) within two weeks prior to obtaining consent. However, this does not include the use of stimulant laxatives at a frequency equivalent to rescue therapy (generally once every 72 hours). 2) Patients who have taken probiotic preparations (prescription, over-the-counter, or quasi-drugs) within four weeks prior to obtaining consent. 3) Patients who had muddy or watery stools (Bristol Stool Scale 6 or 7) during spontaneous bowel movements during the observation period. 4) Patients with megacolon or megarectum. 5) Pregnant patients. 6) Patients taking opioids. 7) Patients with constipation due to organic disease. 8) Patients with constipation due to rectal or anal dysfunction. 9) Patients with a history of or concurrent inflammatory bowel disease. 10) Patients with concomitant infectious gastroenteritis. 11) Patients with a history of surgical resection of the stomach, gallbladder, small intestine, or large intestine (excluding appendicitis and benign polypectomy). 12) Patients with a history of malignant tumors of the digestive system or patients with malignant tumors (excluding digestive tract cancers cured by endoscopic treatment). 13) Patients with other severe cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, or neurological/psychiatric disorders. 14) Other patients deemed inappropriate as study subjects by the principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Complete sponteneous bowel movement (CSBM) frequency per week during the 8-week combination therapy period compared to the 8-week MgO monotherapy period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in the following during the baseline, MgO monotherapy period, and combination therapy period 1) Number of CSBM 2) Number of SBM 3) CSBM rate 4) Bristol stool form scale(BSFS) 5) Bowel movement score 6) Intensity of stool odor 2.Changes in the following during the baseline, Visit 3, Visit 4, Visit 5, and Visit 6 1) JPAC-QOL(total score and each subscore:physical discomfort, mental discomfort, satisfaction, concern/interest) 2) SF-12v2 (8 subscales and summary scores:PCS, MCS) 3) WPAI:GH v2.0(each score:absenteeism, reduced work productivity during attendance, total loss of work productivity, reduced activity) 4) Izumo Scale(total score and each subscore: heartburn symptoms, stomach pain symptoms, stomach discomfort symptoms, FD symptoms, constipation symptoms, diarrhea symptoms) 5) Treatment satisfaction 6) Abdominal symptoms(abdominal bloating, abdominal discomfort, straining, residual stool sensation, abdominal pain) 7) mCSS 3.Changes in the following at baseline, Visit 4, and Visit 6 1) Fecal microbiota analysis 2) Bacterial metabolites in feces 4.The following information on safety during the observation period, MgO monotherapy period, and combination therapy period 1) Incidence of drug-related adverse events 2) Frequency of rescue medication (stimulant laxatives) use 3) Serum magnesium levels | — |
Contacts
Public ContactChiho Shibata
DOT WORLD Co., Ltd.
Outcome results
None listed