Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058839) titled 'A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on loose stool' on Aug. 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Matsumoto City Hospital
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of probiotic ingestion on stool consistency and frequency in healthy adults with loose stool tendency.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intake of test foods for 12 weeks
Interventions/Control_2 - Intake of placebo foods for 12 weeks
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1) Participants aged 18-64 years at the time of obtaining consent.
2) Participants with loose stool tendency who defecate more than 7 times a week, with more than 50% of stools categorized as 5 or 6 in the Bristol stool scale.
Key exclusion criteria - 1) Participants who regularly take medicines that affect the intestinal environment (antibiotics, bowel medicines, laxatives, etc.).
2) Participants who regularly take foods or supplements that contain lactic acid bacteria, bifidobacteria or oligosaccharides, or that affect the intestinal environment.
3) Participants who cannot stop taking health foods, supplements, foods for specified health uses, foods with functional claims, or foods with nutritional function claims which affect the intestinal environment during the study period.
4) Participants receiving treatment for malignant tumors, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine or metabolic diseases, or those with a serious history of these diseases.
5) Participants with a history of digestive tract surgery (except adenoidectomy, appendicitis, etc.).
6) Participants who are diagnosed with, or are suspected of having, irritable bowel syndrome (IBS), functional diarrhea, or functional abdominal pain by principal investigator.
7) Participants with serious drug or food allergies or a history of such allergies.
8) Participants who are pregnant, lactating, or planning to become pregnant during the study period.
9) Participants who regularly drink more than moderate alcohol consumption (pure alcohol equivalent 20 g/day).
10) Participants who smoke habitually 20 or more cigarettes per day.
11) Participants who are expected to experience major changes in their environment during the study period (relocation, job change, etc.).
12) Participants with irregular lifestyle or irregular eating habits.
13) Participants who are planning overseas travel or long-term business trips during the study period.
14) Participants who have participated in other clinical trials within 3 months prior to the date of consent, or who plan to participate in other clinical trials during the study period.
15) Participants who are judged ineligible to this study by principal investigator.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 05 Day
Date of IRB - 2025 Year 08 Month 05 Day
Anticipated trial start date - 2025 Year 08 Month 27 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067282
Disclaimer: Curated by HT Syndication.
