GUTPROH: Probiotic-Herbal Formula for Self-Reported Constipation in Community Adults

Beijing Hospital

Status: Not yet enrolling

Conditions: Functional Constipation (FC)

Treatments: Other: Placebo Intervention; Dietary Supplement: Probiotic Intervention; Dietary Supplement: Probiotic with Herbal Powder Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06955819

2025BJYYEC-KY016-02

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effects of probiotic combined with or without herbal powder on relieving constipation and improving the gut microbiota in community - dwelling people with a demand for improved bowel movements through human feeding trials, and to explore their potential mechanisms of action.

The main research questions are as follows:

Can the probiotic combined with or without herbal powder significantly increase the frequency of defecation in subjects, and at the same time improve fecal characteristics and defecation conditions? Can the the probiotic combined with or without herbal powder regulate the gut microbiota? What are the biological mechanisms by which the probiotic combined with or without herbal powder improve constipation and gut microbiota function? Researchers will compare experimental group 1 (taking the compound probiotic combined with herbal powder), experimental group 2 (taking probiotics alone) with the placebo control group (taking an identical - looking blank matrix powder) to observe their effects on defecation and the gut microbiota.

The main tasks for participants include:

Taking the compound probiotic combined with herbal powder (experimental group 1), probiotics alone (experimental group 2), or blank matrix powder (placebo control group) as required for 12 weeks.

Recording daily defecation frequency, defecation conditions, fecal characteristics, and daily diet, and reporting any adverse reactions.

Longitudinal monitoring employs serial assessments comprising: 1) physical examinations (mental status/vital signs); 2) laboratory diagnostics (hematology/urinalysis/fecal routine tests, hepatic-renal-metabolic panels); 3) ECG and abdominal ultrasonography; and 4) advanced analyses (gut microbiome sequencing and serum metabolomic profiling via LC/MS/MS).

Enrollment: 300 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 35 years or older.
• Self - reported good comprehensive physical health status. Have complaints of irregular bowel movement frequency and a need for improved defecation, or have a spontaneous defecation frequency of less than 3 times per week in the 2 weeks before administration, or meet two or more of the following Rome IV criteria for functional constipation (FC): ① >25% of defecations are difficult; ② >25% of defecations are dry, hard, or pellet - shaped; ③ >25% of defecations have a sense of incomplete evacuation; ④ >25% of defecations have a feeling of anorectal obstruction or blockage; ⑤ >25% of defecations require manual assistance; ⑥ Fewer than 3 spontaneous defecations per week.
• Provide written informed consent voluntarily before the study and be able to fill out the subject log card and research questionnaire as required by the trial protocol.

Exclusion criteria

• Frail elderly people with a score of ≥3 on the FRAIL Frailty Screening Scale.
• Self - reported presence of loose stools.
• Those who have undergone surgery within 30 days, had an acute gastrointestinal disease within 30 days, or have been diagnosed with severe organic diseases causing defecation difficulties (such as colon cancer, intestinal obstruction, inflammatory bowel disease, etc.).
• Patients with severe systemic diseases in the acute phase of cardiovascular, liver, kidney, and hematopoietic systems.
• Patients with symptoms of yin deficiency and internal heat, such as dry mouth, night sweats, restlessness of the five centers (palms, soles, and chest), hard and dry stools with bad breath, red tongue with yellow coating.
• Those who have taken antibiotics within 30 days before the start of the trial.
• Those who have taken probiotics, fermented products, other laxative drugs, or health supplements within 14 days before the start of the trial (i.e., during the wash - out period).
• Those who have not signed the informed consent form. Other situations considered unsuitable for enrollment by the researchers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Placebo Control Group

Placebo Comparator group

Description:

Participants in the placebo control group will take a blank matrix powder. The dosage and administration method are the same as those of the experimental groups. That is, they will take a certain amount of the powder twice a day (the same frequency as the probiotic powder intake in the experimental groups) and once every other day (the same frequency as the herbal powder intake in the experimental groups). The blank matrix powder does not contain probiotics or herbal powder but is designed to have the same appearance as the experimental products. This is to eliminate the placebo effect and serve as a baseline for comparison. During the 12 - week study period, participants in this group also need to record their daily defecation, diet, and adverse reactions, and undergo the same fecal gut microbiota examination and serum mass spectrometry non - targeted metabolomics measurement at week 0, week 4, and week 12 as the experimental groups.

Treatment:

Other: Placebo Intervention

Probiotic Intervention Group

Experimental group

Description:

Subjects in this group will consume Zhigu Zhijian (QingzhiningTM) probiotic powder. The dosage is 2g per time, and it should be taken twice a day, specifically after breakfast and dinner. The probiotic powder is taken with lukewarm water (water temperature ≤ 30℃). The purpose of this intervention is to explore the individual effect of the probiotic on improving defecation and gut microbiota in participants with a need for better bowel movements. The intervention period is 12 weeks. Similar to the other groups, participants are required to keep daily records of defecation - related information, diet, and adverse reactions. They also need to participate in the same series of examinations at week 0, week 4, and week 12 to assess the impact on gut microbiota and metabolic function.

Treatment:

Dietary Supplement: Probiotic Intervention

Probiotic with Herbal Powder Intervention Group

Experimental group

Description:

Participants in this group will take Zhigu Zhijian (QingzhiningTM) probiotic powder at a dosage of 2g per time, twice a day (after breakfast and dinner), and Zhigu Zhijian (QingzhiningTM) herbal powder at a dosage of 15g per time, once every other day (before breakfast). The probiotic powder should be taken with lukewarm water (water temperature ≤ 30℃), and the herbal powder should be taken after being brewed with boiling water. This intervention aims to evaluate the combined effect of the compound probiotic and herbal powder on improving defecation problems and gut microbiota in subjects with defecation - related demands. The duration of the intervention is 12 weeks. During this period, participants need to record their daily defecation frequency, defecation status, fecal characteristics, daily diet, and report any adverse reactions. They also need to participate in the same series of examinations at week 0, week 4, and week 12.

Treatment:

Dietary Supplement: Probiotic with Herbal Powder Intervention