Functional Constipation (FC)NCT06955819
GUTPROH: Probiotic-Herbal Formula for Self-Reported Constipation in Community Adults
A study testing Probiotic Intervention and Probiotic with Herbal Powder Intervention in people with Functional Constipation (FC), run by Beijing Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Probiotic Intervention and Probiotic with Herbal Powder Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: GUTPROH Trial: A Double-Blind, Randomized, Placebo-Controlled Study of Probiotic-Multiherb Formula for Self-Reported Constipation Symptoms in Community-Dwelling Adults
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:
Read more
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)
- Being tested
- Placebo Intervention, Probiotic Intervention, Probiotic with Herbal Powder Intervention
- Keywords
- Probiotic, Herbal powder, Functional constipation, Gut microbiota, Randomized controlled trial, Placebo control, Community population, Efficacy evaluation, Mechanism exploration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo InterventionOther
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.
Probiotic InterventionDietary supplement
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.
Probiotic with Herbal Powder InterventionDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control Group | Placebo comparator | 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. Receives: Other: Placebo Intervention |
| Probiotic Intervention Group | Experimental | 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. Receives: Dietary Supplement: Probiotic Intervention |
| Probiotic with Herbal Powder Intervention Group | Experimental | 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. Receives: Dietary Supplement: Probiotic with Herbal Powder Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spontaneous defecation frequency
The number of spontaneous bowel movements per week. An increase in the frequency of spontaneous defecation in the experimental groups compared to the placebo control group would indicate a potential positive effect of the interventions.
Measured: From the start of intervention (week 0) to the end of the 12 - week intervention period.
Secondary outcomes (2)
Improvement in fecal characteristics
Evaluated using the Bristol Stool Form Scale (a 1-to-7 scale, where 1 represents the most abnormal stool form [e.g., separate hard lumps] and 7 represents the most watery/diarrheal form). An improvement in fecal characteristics is defined as moving from lower-scored forms (1-2, indicating constipation-predominant states) to higher-scored, more "normal" forms (3-5, indicating optimal bowel movement consistency). Higher scores within this context (toward the 3-5 range) signify a better outcome, suggesting a beneficial impact on defecation.
Measured: From the start of intervention (week 0) to the end of the 12 - week intervention period.
Alteration in defecation status
Assessed using a defecation difficulty scoring system (a 0-to-3 scale, where 0 indicates no defecation difficulty and 3 indicates severe defecation difficulty). The scale includes the following scores: 0 = no difficulty; 1 = mild difficulty (e.g., occasional straining); 2 = moderate difficulty (e.g., frequent straining or incomplete evacuation); 3 = severe difficulty (e.g., prolonged straining, use of laxatives, or inability to defecate without assistance). In this scoring system, higher scores represent worse outcomes (i.e., greater defecation difficulty), whereas a reduction in the score (e.g., from 3 to 1) indicates an improvement in defecation status.
Measured: From the start of intervention (week 0) to the end of the 12 - week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start10 Jul 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Collaborators
- Chinese Aging Well Association
- Responsible party
- Sponsor
- Investigators
- Liang Sun, Ph.D, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955819
- Sponsor's protocol ID
- 2025BJYYEC-KY016-02
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUTPROH Trial: A Double-Blind, Randomized, Placebo-Controlled Study of Probiotic-Multiherb Formula for Self-Reported Constipation Symptoms in Community-Dwelling Adults
- ClinicalTrials.gov ID
- NCT06955819
- Acronym / sponsor ID
- 2025BJYYEC-KY016-02
- Conditions
- Functional Constipation (FC)
- Keywords
- Probiotic, Herbal powder, Functional constipation, Gut microbiota, Randomized controlled trial, Placebo control, Community population, Efficacy evaluation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Collaborators
- Chinese Aging Well Association
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Control Group | Placebo comparator | Other: Placebo InterventionParticipants 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. |
| Probiotic Intervention Group | Experimental | Dietary Supplement: Probiotic InterventionSubjects 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. |
| Probiotic with Herbal Powder Intervention Group | Experimental | Dietary Supplement: Probiotic with Herbal Powder InterventionParticipants 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo InterventionSubjects 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. | Other | Placebo Control Group |
| Probiotic InterventionSubjects 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 Intervention Group |
| Probiotic with Herbal Powder InterventionSubjects 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. | Dietary supplement | Probiotic with Herbal Powder Intervention Group |
Primary outcome
Change in spontaneous defecation frequency
Time frame: From the start of intervention (week 0) to the end of the 12 - week intervention period.
The number of spontaneous bowel movements per week. An increase in the frequency of spontaneous defecation in the experimental groups compared to the placebo control group would indicate a potential positive effect of the interventions.
2 secondary outcomes
Improvement in fecal characteristics
Time frame: From the start of intervention (week 0) to the end of the 12 - week intervention period.
Alteration in defecation status
Time frame: From the start of intervention (week 0) to the end of the 12 - week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liang Sun, Ph.D principal investigator
Beijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Intervention and Probiotic with Herbal Powder Intervention in people with Functional Constipation (FC), run by Beijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruiyue Yang, Ph.D (+861085138520, ruiyue_yang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spontaneous defecation frequency (time frame: From the start of intervention (week 0) to the end of the 12 - week intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.