ConstipationNCT07302542
Oat Milk for Laxation
A study testing oat milk in people with Constipation, run by Capital Medical University at 1 site in China.
Trial summary
This study intends to recruit 90-100 constipated participants aged 25-50 years, including an equal number of males and females, from the faculty and logistics staff of Capital Medical University. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- oat milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of non-organic and habitual constipation;
- Reduced defecation frequency;
- Increased stool hardness;
- Fewer than 4 bowel movements per week;
Who cannot join
- Inability to take food orally or inability to comply with the required intake of the test product;
- Known allergy to oats or related products;
- Unclear primary gastrointestinal complaints;
- Physical weakness that prevents participation in the trial;
- History of surgery within the past 30 days that may cause constipation；
- Recent constipation caused by severe organic gastrointestinal lesions (e.g., colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease);
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- Constipation accompanied by significant abdominal pain;
- Acute gastrointestinal diseases within the past 30 days;
- Severe systemic diseases involving the cardiovascular, hepatic, renal, or hematopoietic systems;
- Ongoing treatment for comorbid conditions that may interfere with study participation;
- Recent use of substances related to the tested function that may influence outcome measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Oat Milk Consumption on Gastrointestinal Transit and Defecation Frequency: A Controlled Intervention Trial in Adults
This study intends to recruit 90-100 constipated participants aged 25-50 years, including an equal number of males and females, from the faculty and logistics staff of Capital Medical University. Participants will be randomly divided into an intervention group (55-60 individuals) and a control group (35-40 individuals). The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 4 weeks, while the control group will not receive oat milk intervention. Both groups will maintain their original lifestyles, including diet, sleep, and exercise, throughout the study period. Baseline surveys, dietary surveys, blood and urine routine tests, blood biochemical indices, and intestinal flora detection will be conducted before and after the intervention. Defecation status will be recorded, and gastrointestinal symptoms will be assessed using a Gastrointestinal Symptom Rating Scale. Statistical analysis will be performed to determine the laxative efficacy of oat milk.
- Conditions
- Constipation
- Being tested
- oat milk
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oat milkDietary supplement
The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Dietary Supplement: oat milk |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing
Fecal samples from a randomly selected subgroup (30 participants in the intervention group and 15 in the control group) will be collected before and after the intervention. Metagenomic sequencing will be used to evaluate changes in intestinal microbiota composition and functional gene pathways, including metabolism-, immunity-, and disease-related gene sets. This outcome explores potential mechanisms by which the intervention exerts laxative effects.
Measured: Collect feces and evaluate at baseline and at the fourth week.
Secondary outcomes (1)
Changes in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale
Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS, 15 items; score range: 1-7, with higher scores indicating more severe symptoms). Assessments will be conducted at baseline, Week 2, and Week 4. Symptoms include reflux, abdominal pain, indigestion, diarrhea, and constipation.
Measured: Participates will fill out the questionnaire at baseline, Week 2, and Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start15 Dec 2025
- Primary completion15 Jan 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuwen Ren, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302542
- Sponsor's protocol ID
- MNCGJH-20250903-0022
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oat Milk Consumption on Gastrointestinal Transit and Defecation Frequency: A Controlled Intervention Trial in Adults
- ClinicalTrials.gov ID
- NCT07302542
- Acronym / sponsor ID
- MNCGJH-20250903-0022
- Conditions
- Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 24 Dec 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.
This study intends to recruit 90-100 constipated participants aged 25-50 years, including an equal number of males and females, from the faculty and logistics staff of Capital Medical University. Participants will be randomly divided into an intervention group (55-60 individuals) and a control group (35-40 individuals). The intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 4 weeks, while the control group will not receive oat milk intervention. Both groups will maintain their original lifestyles, including diet, sleep, and exercise, throughout the study period. Baseline surveys, dietary surveys, blood and urine routine tests, blood biochemical indices, and intestinal flora detection will be conducted before and after the intervention. Defecation status will be recorded, and gastrointestinal symptoms will be assessed using a Gastrointestinal Symptom Rating Scale. Statistical analysis will be performed to determine the laxative efficacy of oat milk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: oat milk |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of non-organic and habitual constipation;
- Reduced defecation frequency;
- Increased stool hardness;
- Fewer than 4 bowel movements per week;
Key exclusion criteria (11 listed)
- Inability to take food orally or inability to comply with the required intake of the test product;
- Known allergy to oats or related products;
- Unclear primary gastrointestinal complaints;
- Physical weakness that prevents participation in the trial;
- History of surgery within the past 30 days that may cause constipation；
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 |
|---|---|---|
| oat milkThe intervention group will consume 250 mL of Mengniu Daily Fiber Oat Milk daily for 28 consecutive days | Dietary supplement | Intervention Group |
Primary outcome
Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing
Time frame: Collect feces and evaluate at baseline and at the fourth week.
Fecal samples from a randomly selected subgroup (30 participants in the intervention group and 15 in the control group) will be collected before and after the intervention. Metagenomic sequencing will be used to evaluate changes in intestinal microbiota composition and functional gene pathways, including metabolism-, immunity-, and disease-related gene sets. This outcome explores potential mechanisms by which the intervention exerts laxative effects.
1 secondary outcome
Changes in Gastrointestinal Symptoms Assessed by the Gastrointestinal Symptom Rating Scale
Time frame: Participates will fill out the questionnaire at baseline, Week 2, and Week 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oat milk in people with Constipation, run by Capital Medical University at 1 site in China.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Intestinal Flora Composition Assessed by Metagenomic Sequencing (time frame: Collect feces and evaluate at baseline and at the fourth week.). 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 22 Oct 2026.