A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients
NCT05900752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2023-11-24
Summary
The goal of this interventional clinical study is to study whether the consumption of QiMeiYan Probiotics in 25-35 young people with Mild irritable bowel syndrome (IBS Score 75 - 175) will reduce the frequency of Diarrhea.
140 eligible participants (70 males and 70 females) will be enrolled in two study sites and randomly assigned to two groups of products QiMeiYan Probiotics and placebo. All participants will consume assigned products once a day after meals and record the critical data such as photo of feces. Three site visits will be arranged and all clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis.
Researchers will compare the two groups to validate if the daily consumption of QiMeiYan Probiotics will reduce the frequency of Diarrhea in the study population.
Conditions
- IBS - Irritable Bowel Syndrome
- Diarrhea
Interventions
- DIETARY_SUPPLEMENT
-
QiMeiYan Probiotics
consume one sachet of the assigned product, once a day after meals.
- DIETARY_SUPPLEMENT
-
Placebo product
consume one sachet of the assigned product, once a day after meals.
Sponsors & Collaborators
-
Shenzhen Precision Health Food Technology Co. Ltd.,
lead OTHER_GOV
Principal Investigators
-
Ruiming Xu, MD · Shanghai Jiao Tong University School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-19
- Primary Completion
- 2023-07-16
- Completion
- 2023-07-16
Countries
- China
Study Locations
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