NCT06955819

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

GUTPROH Trial: A Double-Blind, Randomized, Placebo-Controlled Study of Probiotic-Multiherb Formula for Self-Reported Constipation Symptoms in Community-Dwelling Adults

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Functional Constipation (FC)

Interventions

Type	Name	Description
OTHER	Placebo Intervention	Subjects will be given a blank matrix powder with the same appearance as the products in the experimental groups, which does not contain probiotics or herbal powder. The dosage, frequency, and administration method are exactly the same as those in Experimental Group. Intervention duration will be 12 weeks, carried out synchronously with the experimental groups to ensure the consistency of research conditions.
DIETARY_SUPPLEMENT	Probiotic Intervention	Subjects will take Zhigu Zhijian (QingzhiningTM) probiotic powder, 2g per sachet, twice a day, one sachet after breakfast and one after dinner, taken with lukewarm water (water temperature ≤ 30℃). Intervention duration will also be 12 weeks, for parallel comparison with other groups.
DIETARY_SUPPLEMENT	Probiotic with Herbal Powder Intervention	Subjects in this group will be given Zhigu Zhijian (QingzhiningTM) probiotic powder and Zhigu Zhijian (QingzhiningTM) herbal powder. The probiotic powder is 2g per sachet, taken twice a day, one sachet after breakfast and one after dinner, and should be taken with lukewarm water (water temperature ≤ 30℃). The herbal powder is 15g per sachet, taken once every other day before breakfast, and should be taken after being brewed with boiling water. Intervention duration will be last for 12 weeks to ensure sufficient time to observe the long - term effects on defecation and gut microbiota.

Timeline

• Start date: 2025-07-10
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2025-05-02
• Last updated: 2025-06-26