Research on the Role of Compound Probiotic Freeze-dried Powder in Improving Gastrointestinal Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Improvement of gastrointestinal function in study participants
Study Overview
Brief Summary
This study aims to evaluate the effect of four high-activity compound probiotic freeze-dried powders on improving gastrointestinal function, observing their regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 4-week intervention period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study
- •Able to complete the study according to the requirements of the trial protocol
- •Age between 18 and 65 years old
- •Meet the diagnostic criteria for gastrointestinal dysfunction established in the "Chinese Precision Health Communication Expert Consensus on Citizen's Guide to Gastrointestinal Health"
- •Symptoms: Irregular bowel movements, loose or hard stools, abdominal bloating, belching, flatulence, severe intestinal gas, abdominal pain, acid reflux, heartburn, pain in the stomach or abdomen when hungry, nausea
- •Signs: Abdominal pain and bloating, diarrhea and constipation, indigestion, gastric acid reflux, bad breath and foul-smelling flatulence, skin problems, changes in stool color and shape -
Exclusion Criteria
- •Use of drugs affecting the intestinal flora (including antimicrobials, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week continuously within 1 month prior to screening
- •Short-term consumption of products similar to the test substance, which affects the judgment of the results
- •Use of antibiotics during illness
- •Participants with severe systemic diseases or malignant tumors
- •Participants allergic to any components of the compound probiotic freeze-dried powder used in this trial
- •Women who are pregnant or breastfeeding, or those who have plans to conceive in the near future
- •Participants who cannot participate in the trial due to personal reasons
- •Other participants deemed unsuitable for participation by the researcher -
Arms & Interventions
Wec1000B group
Participants will take the probiotic freeze-dried powder daily, each serving being 3.0 grams, to be consumed half an hour after meals.
Intervention: Probiotic (Dietary Supplement)
Wec600B group
Participants will take the probiotic freeze-dried powder daily, each serving being 3.0 grams, to be consumed half an hour after meals.
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
Improvement of gastrointestinal function in study participants
Time Frame: 4 weeks
Bowel movement frequency improvement: use the "bowel movement frequency scale" to record the number of bowel movements per week for participants, in order to assess changes in bowel movement frequency.
Secondary Outcomes
- Concentration of Short-Chain Fatty Acids in Fecal Samples(4 weeks)
- Metabolite Profile in Fecal Samples as an Indicator of Intestinal Microbiota Health(4 weeks)