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Completed

NCT Number: NCT06781814

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Food and Bioengineering, Henan University of Science and Technology

Luoyang, Henan, 471000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Probiotic

Dietary Supplement

Probiotic strips with different strain formulas, specification: 3g/bag. Storage method: Keep away from light, seal tightly, and store in a cool, dry place.

Primary outcomes

  1. 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

  1. Concentration of Short-Chain Fatty Acids in Fecal Samples

    Time frame: 4 weeks

    The concentration of short-chain fatty acids in fecal samples was determined by gas chromatography-mass spectrometry (GC-MS).

  2. Metabolite Profile in Fecal Samples as an Indicator of Intestinal Microbiota Health

    Time frame: 4 weeks

    The metabolites in fecal samples were detected by liquid chromatography-mass spectrometry (LC-MS).

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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