Research on the Role of Compound Probiotic Freeze-dried Powder in Improving Gastrointestinal Function

Wecare Probiotics

Status: Completed

Conditions: Gastrointestinal Function

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06781814

WK20241231

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study
2. Able to complete the study according to the requirements of the trial protocol
3. Age between 18 and 65 years old
4. Meet the diagnostic criteria for gastrointestinal dysfunction established in the "Chinese Precision Health Communication Expert Consensus on Citizen's Guide to Gastrointestinal Health"
5. 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
6. 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

1. 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
2. Short-term consumption of products similar to the test substance, which affects the judgment of the results
3. Use of antibiotics during illness
4. Participants with severe systemic diseases or malignant tumors
5. Participants allergic to any components of the compound probiotic freeze-dried powder used in this trial
6. Women who are pregnant or breastfeeding, or those who have plans to conceive in the near future
7. Participants who cannot participate in the trial due to personal reasons
8. Other participants deemed unsuitable for participation by the researcher -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Wec600B group

Experimental group

Description:

Participants will take the probiotic freeze-dried powder daily, each serving being 3.0 grams, to be consumed half an hour after meals.

Treatment:

Dietary Supplement: Probiotic

Wec1000B group

Experimental group

Description:

Participants will take the probiotic freeze-dried powder daily, each serving being 3.0 grams, to be consumed half an hour after meals.

Treatment:

Dietary Supplement: Probiotic