GoutNCT04199325
Probiotics for Gout / Hyperuricemia: A Randomized, Intervention, Parallel Controlled, Multicenter Clinical Trial
A study testing Probiotics and uric-acid-lowering drug in people with Gout and Hyperuricemia, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
Trial summary
Under the premise of double-blind and non-interference clinical treatment, to evaluate the clinical efficacy and safety of probiotic Lactobacillus Zhang combined with routine treatment for gout hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Probiotics and uric-acid-lowering drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to Mar 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible for inclusion in this study only if they meet all of the following criteria
- 18-70 years old, gender unlimited ；
- Previous history of gout ；
- According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015；
- fasting serum uric acid ≥ 480 μ mol / L (8mg / dl)
Who cannot join
- If the subjects meet any of the following criteria, they will not be selected ：
- Gout in the past two weeks ；
- Secondary hyperuricemia ；
- Patients with abnormal liver and kidney function (ALT, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the upper limit of the normal value；
- WBC < 4.0 × 109 / L, PLT < 100 × 109 / L, HGB < 90g / L, or other hematological diseases ；
- bad blood pressure control (BP>160mmHg/100 mmHg)
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- Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ；
- Patients with active peptic ulcer ；
- Patients with gastrointestinal cancer ；
- Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ；
- Use of drugs that affect the metabolism or excretion of uric acid and cannot / cannot be stopped, including azathioprine, 6-mercaptopterin, thiazide diuretics, aspirin (more than 325mg / day) or other salicylates ；
- Those who need continuous prednisone treatment ；
- Those who need antibiotic treatment for infectious diseases ；
- Those with body mass index (BMI) greater than 30 ；
- people with alcoholism ；
- People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ；
- Researchers who have received other drugs within 3 months before screening ；
- The people who are researchers thinks it is not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Inner Mongolia Medical College Affiliated Hospital
Hohhot, Inner Mongolia, 010000
Hong-bin LI, M.D, +86 13948536552, lhbwb73@126.com
About this study
Official title: Probiotics for Gout / Hyperuricemia: A Randomized, Double-blind, Intervention, Parallel Controlled, Multicenter Clinical Trial
Under the premise of double-blind and non-interference clinical treatment, to evaluate the clinical efficacy and safety of probiotic Lactobacillus Zhang combined with routine treatment for gout hyperuricemia.
- Conditions
- Gout, Hyperuricemia
- Being tested
- Probiotics, uric-acid-lowering drug
- Keywords
- gout, hyperuricemia, probiotics
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
uric-acid-lowering drugDrug
Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Dietary Supplement: Probiotics; Drug: uric-acid-lowering drug |
| Control group | Placebo comparator | Not described Receives: Drug: uric-acid-lowering drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum uric acid level
The serum uric acid level was standard-reaching rate at the end of 24 weeks(Percentage of patients whose serum uric acid level has decreased to less than 360umol / L )
Measured: 24 weeks
Secondary outcomes (3)
serum uric acid level at the 4、8、12、24 weeks
the serum uric acid level and the percentage of patients with < 360umol / L at the end of 4, 8, 12 and 24 weeks after treatment
Measured: 4、8、12、24 weeks
serum uric acid decreased from baseline
At the end of 4, 8, 12 and 24 weeks after treatment, the serum uric acid level decreased from baseline
Measured: 4、8、12、24 weeks
Acute attack of gout
Number of acute gout attacks during 24 weeks of treatment
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Nov 2018
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies 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, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia University of Science and Technology, Inner Mongolia Hulunboir hospital, Inner Mongolia People's Hospital, Inner Mongolia Ordos Central Hospital, Inner Mongolia Baogang Hospital, Inner Mongolia Medical College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199325
- Sponsor's protocol ID
- qpfff@126.com
- Status last verified
- Jul 2023
- First submitted
- 12 Dec 2019
- Last updated
- 20 Jul 2023
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Gout / Hyperuricemia: A Randomized, Double-blind, Intervention, Parallel Controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04199325
- Acronym / sponsor ID
- qpfff@126.com
- Conditions
- Gout, Hyperuricemia
- Keywords
- gout, hyperuricemia, probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical UniversityUniversity, hospital or other
- Collaborators
- Inner Mongolia University of Science and Technology, Inner Mongolia Hulunboir hospital, Inner Mongolia People's Hospital, Inner Mongolia Ordos Central Hospital, Inner Mongolia Baogang Hospital, Inner Mongolia Medical College
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Dec 2019 (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.
Under the premise of double-blind and non-interference clinical treatment, to evaluate the clinical efficacy and safety of probiotic Lactobacillus Zhang combined with routine treatment for gout hyperuricemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Probiotics, Drug: uric-acid-lowering drug |
| Control group | Placebo comparator | Drug: uric-acid-lowering drug |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects are eligible for inclusion in this study only if they meet all of the following criteria
- 18-70 years old, gender unlimited ；
- Previous history of gout ；
- According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015；
- fasting serum uric acid ≥ 480 μ mol / L (8mg / dl)
Key exclusion criteria (18 listed)
- If the subjects meet any of the following criteria, they will not be selected ：
- Gout in the past two weeks ；
- Secondary hyperuricemia ；
- Patients with abnormal liver and kidney function (ALT, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the upper limit of the normal value；
- WBC < 4.0 × 109 / L, PLT < 100 × 109 / L, HGB < 90g / L, or other hematological diseases ；
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 |
|---|---|---|
| ProbioticsPatients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio. | Dietary supplement | Intervention group |
| uric-acid-lowering drugPatients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio. | Drug | Control group, Intervention group |
Primary outcome
serum uric acid level
Time frame: 24 weeks
The serum uric acid level was standard-reaching rate at the end of 24 weeks(Percentage of patients whose serum uric acid level has decreased to less than 360umol / L )
3 secondary outcomes
serum uric acid level at the 4、8、12、24 weeks
Time frame: 4、8、12、24 weeks
serum uric acid decreased from baseline
Time frame: 4、8、12、24 weeks
Acute attack of gout
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics and uric-acid-lowering drug in people with Gout and Hyperuricemia, run by The Affiliated Hospital of Inner Mongolia 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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum uric acid level (time frame: 24 weeks). 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 20 Jul 2023.