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RecruitingNCT04199325Updated Jul 20, 2023

Probiotics for Gout / Hyperuricemia: A Randomized, Intervention, Parallel Controlled, Multicenter Clinical Trial

An interventional study of Probiotics and uric-acid-lowering drug in Gout and Hyperuricemia, sponsored by The Affiliated Hospital of Inner Mongolia Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by The Affiliated Hospital of Inner Mongolia Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2018, registered Dec 2019).
  • Started Nov 2018; still recruiting 8 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gout
  • Hyperuricemia

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Keywords

  • gout
  • hyperuricemia
  • probiotics
03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's planned enrollment of 300 is above the median of 83 across 286 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

The Affiliated Hospital of Inner Mongolia Medical University is the lead sponsor of 9 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subjects are eligible for inclusion in this study only if they meet all of the following criteria

  1. 18-70 years old, gender unlimited ;
  2. Previous history of gout ;
  3. According to the criteria of gout classification and diagnosis of EULAR / ACR in 2015;
  4. fasting serum uric acid ≥ 480 μ mol / L (8mg / dl)

Exclusion criteria

Exclusion Criteria:

If the subjects meet any of the following criteria, they will not be selected :

  1. Gout in the past two weeks ;
  2. Secondary hyperuricemia ;
  3. Patients with abnormal liver and kidney function (, AST are 1.5 times higher than the normal value, Cr is 1.5 times higher than the value;
  4. WBC \< 4.0 × 109 / L, \< 100 × 109 / L, HGB \< 90g / L, or other hematological diseases ;
  5. bad blood pressure control (BP>160mmHg/100 mmHg)
  6. Type I diabetes or poorly controlled type II diabetes: fasting blood glucose ≥ 8.5mmol/l ;
  7. Patients with active peptic ulcer ;
  8. Patients with gastrointestinal cancer ;
  9. Patients with previous intestinal diseases such as lactose intolerance, irritable bowel syndrome, inflammatory bowel disease and habitual diarrhea ;
  10. 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 ;
  11. Those who need continuous prednisone treatment ;
  12. Those who need antibiotic treatment for infectious diseases ;
  13. Those with (BMI) greater than 30 ;
  14. people with alcoholism ;
  15. People with a history of allergy to Lactobacillus and its products or with high sensitive constitution ;
  16. Researchers who have received other drugs within 3 months before screening ;
  17. The people who are researchers thinks it is not suitable to participate in the study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Dietary Supplement: Probiotics · Drug: uric-acid-lowering drug

  • Placebo comparator
    Control group

    Drug: uric-acid-lowering drug

Interventions

  • Dietary supplementProbiotics

    Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.

  • Druguric-acid-lowering drug

    Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.

06

What researchers measure

Primary outcomes

  1. 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 )

    Time frame: 24 weeks

Secondary outcomes

  1. 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

    Time frame: 4、8、12、24 weeks

  2. 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

    Time frame: 4、8、12、24 weeks

  3. Acute attack of gout

    Number of acute gout attacks during 24 weeks of treatment

    Time frame: 24 week

07

Study locations

1 of 1 sites recruiting
  • Inner Mongolia Medical College Affiliated Hospital
    Hohhot, Inner Mongolia 010000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04199325
Lead sponsor
The Affiliated Hospital of Inner Mongolia Medical University
Collaborators
Inner Mongolia Agricultural University, 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
First posted
Dec 13, 2019
Start date
Nov 1, 2018
Primary completion
Dec 2023 (estimated)
Completion
Mar 2024 (estimated)
Last update
Jul 20, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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